Effectiveness of nutrition counseling for pregnant women in low‐ and middle‐income countries to improve maternal and infant behavioral, nutritional, and health outcomes: A systematic review

Omar Dewidar; Jessica John; Aqeel Baqar; Mohamad Tarek Madani; Ammar Saad; Alison Riddle; Erika Ota; Jacqueline K Kung'u; Mandana Arabi; Manoj Kumar Raut; Seth S Klobodu; Sarah Rowe; Jennifer Hatchard; Jennifer Busch‐Hallen; Chowdhury Jalal; Sara Wuehler; Vivian Welch

doi:10.1002/cl2.1361

. 2023 Nov 29;19(4):e1361. doi: 10.1002/cl2.1361

Effectiveness of nutrition counseling for pregnant women in low‐ and middle‐income countries to improve maternal and infant behavioral, nutritional, and health outcomes: A systematic review

Omar Dewidar ^1,^✉, Jessica John ², Aqeel Baqar ³, Mohamad Tarek Madani ¹, Ammar Saad ³, Alison Riddle ¹, Erika Ota ⁴, Jacqueline K Kung'u ⁵, Mandana Arabi ⁶, Manoj Kumar Raut ⁷, Seth S Klobodu ⁸, Sarah Rowe ⁹, Jennifer Hatchard ⁹, Jennifer Busch‐Hallen ⁹, Chowdhury Jalal ¹⁰, Sara Wuehler ⁹, Vivian Welch ^1,³

PMCID: PMC10687348 PMID: 38034903

Abstract

Background

Nutritional counseling, which includes two‐way interactive education, has been hypothesized to improve the health and nutritional status of pregnant women, but little is known about the impact such practice of care might have on maternal and infant health and behavioral outcomes of pregnant women living in low income, low‐middle income, and upper‐middle‐income countries (LMIC)s.

Objectives

We conducted a systematic review to appraise the effectiveness and impact on health equity of two‐way nutritional counseling practices in LMICs on maternal and infant behavioral, nutritional, and health outcomes.

Search Methods

We conducted electronic searches for relevant studies on Medline, Embase, CINAHL, PsychInfo, and the Cochrane CENTRAL for randomized and non‐randomized trials on the effectiveness of two‐way interactive nutritional counseling among pregnant women from the date of database inception up to June 22, 2021. In addition, we searched references of included studies in systematic reviews, gray literature resources, and unpublished studies or reports that satisfied our eligibility criteria using a focused Google search.

Selection Criteria

We included randomized and non‐randomized controlled studies (NRS), controlled before and after, and interrupted time series that assessed the effectiveness of two‐way interactive nutrition counseling targeting pregnant women in LMICs.

Data Collection and Analysis

Data extraction and risk of bias were conducted in duplicate. The risk of bias (ROB) for randomized trials (RCT) was assessed according to the Cochrane Handbook of Systematic Reviews, and ROB for NRS was assessed using the Newcastle‐Ottawa scale (NOS). RCT and NRS were meta‐analyzed separately.

Main Results

Our search identified 6418 records and 52 studies met our inclusion criteria, but only 28 were used in the quantitative analysis. Twenty‐eight studies were conducted in Asia, the most in Iran. Eight studies were conducted in Africa. Two‐way interactive nutritional counseling during pregnancy may improve dietary caloric intake (mean difference [MD]: 81.65 calories, 95% confidence interval [CI], 15.37–147.93, three RCTs; I ² = 42%; moderate certainty of evidence using GRADE assessment), may reduce hemorrhage (relative risk [RR]: 0.63; 95% CI, 0.25–1.54, two RCTs; I ² = 40%; very low certainty of evidence using GRADE assessment), may improve protein (MD: 10.44 g, 95% CI, 1.83–19.05, two RCTs; I ² = 95%; high certainty of evidence using GRADE assessment), fat intake (MD: 3.42 g, 95% CI, −0.20 to 7.04, two RCTs; I ² = 0%; high certainty of evidence using GRADE assessment), and may improve gestational weight gain within recommendations (RR: 1.84; 95% CI, 1.10–3.09, three RCTs; I ² = 69%). Nutrition counseling probably leads to the initiation of breastfeeding immediately after birth (RR: 1.72; 95% CI, 1.42–2.09, one RCT). There was little to no effect on reducing anemia (RR: 0.77; 95% CI, 0.50–1.20, three RCTs; I ² = 67%; very low certainty of evidence using GRADE assessment) risk of stillbirths (RR: 0.81; 95% CI, 0.52–1.27, three RCTs; I ² = 0%; moderate certainty of evidence using GRADE assessment) and risk of cesarean section delivery (RR: 0.96; 95% CI, 0.76–1.20, four RCTs; I ² = 36%; moderate certainty of evidence using GRADE assessment).

Authors’ Conclusions

Our review highlights improvements in maternal behavioral and health outcomes through interactive nutrition counseling during pregnancy. However, we are uncertain about the effects of nutrition counseling due to the low certainty of evidence and a low number of studies for some key outcomes. Moreover, the effects on health equity remain unknown. More methodologically rigorous trials that focus on a precise selection of outcomes driven by the theory of change of nutrition counseling to improve maternal and infant behavioral and health outcomes and consider equity are required.

1. PLAIN LANGUAGE SUMMARY

1.1. Nutrition counseling may improve some maternal and infant health and behavioral nutrition outcomes, but more high‐quality studies are needed

A balanced diet during pregnancy is vital for women's health, positive pregnancy outcomes, and proper fetal growth and development. The World Health Organization (WHO) recommends nutrition counseling as part of regular antenatal care contacts to improve nutrition practices and health outcomes.

Two‐way interactive nutrition counseling involves discussions and shared decision‐making between patient and provider. Our review found that this approach for nutrition counseling has a positive effect on some maternal outcomes but not others.

1.2. What is this review about?

Poor maternal nutrition is prevalent among pregnant women in low‐ and middle‐income countries (LMICs). Nutrition deficiencies are strongly associated with maternal and infant health complications. This review aims to identify and synthesize the evidence for the effects of nutrition counseling on pregnant women living in LMICs on maternal infant and child behavioral, nutritional, and health outcomes.

What is the aim of this review?

This Campbell systematic review examines the effectiveness of two‐way interactive nutrition counseling for pregnant women in LMICs on improving maternal and infant health and behavioral outcomes and its impact on health equity.

1.3. What studies are included?

Eligible studies had to be randomized controlled trials (RCTs), non‐randomized controlled studies, controlled before‐after studies, or interrupted time series studies evaluating the impact of nutrition counseling compared to standard care among pregnant women with no pregnancy‐related complications living in LMICs.

Fifty‐two studies were included in the review. Of these, 28 reported outcomes of interest. All the studies compared nutrition counseling to standard antenatal care. Studies were conducted mainly in Asia (28 studies) and Africa (8 studies).

1.4. What are the main findings of this review?

Nutrition counseling may improve dietary caloric intake, protein and fat intake, and gestational weight gain within health recommendations and may reduce hemorrhage during post‐delivery.

Little to no effect was found in reducing the risk of cesarian delivery or improving hemoglobin concentration.

Nutrition counseling shows little to no difference in reducing the rate of stillbirths and anemia.

No studies reported the effects of nutrition counseling on maternal mortality, iron deficiency, or assessed iron intake.

1.5. What do the findings of this review mean?

Our review highlights improvements in maternal behavioral and health outcomes through interactive nutrition counseling during pregnancy. However, inconsistencies in the definition of nutrition counseling studies conducted in LMICs and low certainty of evidence limit our interpretation of the findings. Thus, high‐quality studies with a standardized definition of nutrition counseling that highlights the interactive nature of the practice and a clear theory of change for maternal and infant behavioral and health outcomes are needed.

Findings for impact on health equity were scarce and uncertain.

1.6. How up‐to‐date is this review?

The review authors searched for studies up to June 2021.

2. BACKGROUND

2.1. The problem, condition, or issue

A healthy, balanced diet is necessary for a positive pregnancy experience. Pregnant women have the right to quality antenatal care (ANC). Evidence shows that fetal growth and maternal physical and mental health during pregnancy require increased nutritional demands (Mousa et al., 2019). Nutritional deficiencies are highly prevalent among pregnant women, specifically in low‐ and middle‐income countries (LMICs), contributing to preventable adverse maternal and birth outcomes (Darnton‐Hill & Mkparu, 2015; Viswanathan et al., 2008). Observational studies have indicated that gestational weight gain and energy intake are strongly associated with better birth outcomes, especially in undernourished women (Kramer, 1987; Kramer et al., 2008; Rush, 2001). Additionally, micronutrient deficiencies affect the maternal capacity to conceive and support the pregnancy through birth (Gernand et al., 2016). Substantial evidence exists to support that nutrition counseling, in the presence or absence of other communication channels and tools, carries the potential to improve nutrition practices and health outcomes, in part, through health education and promotion (Bhutta et al., 2008; Bhutta et al., 2013; Graziose et al., 2018; Mbuagbaw et al., 2015; Tekelab et al., 2019; World Health Organization, 2016).

The World Health Organization recommends “Counseling on healthy eating and physical activity” to be integral to women's ANC (World Health Organization, 2016). Despite the potential impact of nutrition counseling, limited time, infrastructure, staff capacity, and motivation often hinder or prevent the delivery of quality ANC in low‐resource settings—and often, challenges in the delivery of nutrition counseling occur (Girard & Olude, 2012). Nutrition counseling provides a critical communication channel between the patient and healthcare provider to identify the patient's nutritional problems, needs and goals, and ways to achieve them. However, the setting where the counseling is conducted may impact the effectiveness of the practice. For example, many evidence‐based nutrition actions achieve the desired outcomes when women and mothers use a recommended nutrition practice at home (Fox et al., 2018). Furthermore, if a supportive enabling environment is in place (e.g., if maternal micronutrient supplements are available at distribution points in adequate quantities and quality, supportive health care policies are in place, and there is adequately compensated and distributed health staff), then quality nutritional counseling with beneficiaries has been shown to improve provider job satisfaction, retention, and ability to provide nutrition services to a higher quality standard (Girard & Olude, 2012; Sunguya, Poudel, Mlunde, Shakya, et al., 2013; Sunguya, Poudel, Mlunde, Urassa, et al., 2013). This, in turn, can affect maternal and infant health outcomes. A better understanding of the current coverage of interactive nutrition counseling during ANC in LMICs can help better target resources and advocacy for accelerated progress toward the Sustainable Development Goals (SDGs).

Pregnant women in LMICs are at an increased risk of facing unjust or unfair health disparities, especially during the critical time of their pregnancy. The systematic social disadvantage associated with living in low‐resource settings jeopardizes the quality of the ANC they receive. As well, health inequities, differences in health that are avoidable and unjust (Whitehead, 1992), could be further magnified by the disadvantages they experience due to their place of residence, race and culture, occupation, gender and sex, religion, education, socioeconomic status, social capital, plus: personal characteristics (i.e., age, disabilities), relationship features (i.e., exclusion from school, parent drug use), and time‐dependent relationships (i.e., times when an individual might be temporarily disadvantaged such as pregnancy). Such characteristics are better known using the acronym PROGRESS+, which provides a useful framework to identify differences in health outcomes among socially disadvantaged populations (O'Neill et al., 2014).

2.2. The intervention

Nutrition counseling practices have varied considerably (Vasiloglou et al., 2019). Therefore, we defined the intervention based on the World Food Program (Programme, 2014 ): “Counseling provided to individuals or in group sessions, that includes two‐way interactive education linked to promoting specific behaviors.” There is growing interest in identifying the effectiveness of nutrition counseling during pregnancy on antenatal and postpartum women's health and behavioral outcomes, and neonates’ health outcomes. Thus, this review investigates the effectiveness of identified two‐way interactive nutrition counseling practices at improving maternal and infant nutrition and health in LMICs.

2.3. How the intervention might work

Figure 1's Logic Model summarizes key components of interest on the path from nutrition counseling to desirable outcomes. This model formed the framework for selecting indicators and their analyses while recognizing that published research might only collect and report on certain components of interest. Women's empowerment is positively associated with improved health and nutrition outcomes for women and infants (Carlson et al., 2015; Cunningham et al., 2015; Pratley, 2016). Knowledge, awareness, motivation, and access are desirable outputs and outcomes to support women's empowerment. Thus, nutrition counseling that incorporates an empowerment approach, with a minimum of two‐way interactive education, may improve intervention uptake and effectiveness by increasing women's agency to act on the information provided through nutrition counseling sessions. In turn, the program can create a supportive opportunity structure (Alsop, 2005) where women can access the necessary material, financial and social support to effect positive change. We have adapted the empowerment model used by Riddle et al. to reflect the causal pathways through which an empowerment approach may contribute to improved health and nutrition outcomes for pregnant women and their infants. We adopt the definition of empowerment developed by Kabeer: “The expansion in people's ability to make strategic life choices in a context where this ability was previously denied to them” (Kabeer, 1999). We aimed to collect the characteristics of the counseling programs to determine elements of an effective structure for nutrition counseling.

Logic model: Nutrition counseling to improve maternal and infant behavioral and health outcomes. Figure adapted from Nutrition International's *Quality Nutrition Counseling in Antenatal Care*: *What Is It and What is Needed?* poster presented at the 2020 Micronutrient Forum Conference.

As part of this review, we looked for evidence of nutrition counseling that applied a complete empowerment model. We defined a complete empowerment model as including two components as outlined in Riddle et al.: (1) Nutrition counseling to foster agency and (2) activities to create a supportive opportunity structure.

First, nutrition counseling that fosters agency should provide participants with a “space for self‐reflection and identification of important life areas” in relation to their nutritional status (Shankar et al., 2019). In other words, desirable counseling provides opportunities for participants to identify and assess barriers to improving their nutritional situation and identifying goals and opportunities to improve their nutritional status. In turn, this is expected to increase their motivation for behavior change and self‐efficacy. Second, activities to create a supportive opportunity structure will provide participants with the necessary material, social or financial resources needed to act on the knowledge and skills they acquire through nutrition counseling (Alsop, 2005; Kabeer, 1999). This includes altering the constraining political, economic, socio‐cultural, intrafamilial, or legal structures (both formal and informal) that can limit behavior change (Alsop, 2005; Mahotra Anju & Boender, 2002). Examples of opportunity structure‐related activities are engaging participants’ families in nutrition counseling to increase their awareness and support for proper nutrition during pregnancy or providing financial support to participants to increase their access to food or health services.1

2.3.1. Knowledge and awareness, outputs

Nutrition‐related health education embedded in nutrition counseling to pregnant women can help reduce the risk of developing nutritional‐specific complications throughout pregnancy, during labor and delivery (Girard & Olude, 2012). The common characteristic of such counseling lies in the provision of direct or indirect communication focusing on influencing their knowledge about the importance of a nutritious and balanced diet during pregnancy, and improving their behaviors and attitudes toward the use of necessary nutritional supplements such as fortified foods and micronutrient supplements when appropriate (Arrish et al., 2014). Nutrition counseling for pregnant women also seeks to influence their behavior with regard to accessing quality ANC services, promoting delivery at the health facility, accessing quality postnatal care services, and adequate intent and young child feeding practices (Alam et al., 2005; Girard & Olude, 2012; Perumal et al., 2013).

2.3.2. Empowerment‐based counseling

We hypothesize that nutrition counseling during ANC conducted through home visits, one‐on‐one facility counseling, and/or interactive group meetings with community and facility‐based health personnel while covering the importance of maternal nutrition, including improving food quality and micronutrient supplementation would increase the women's knowledge of nutrition‐related information according to international practice guidelines. Similarly, the frequency (dose) of patient interactions is expected to affect the effectiveness of the intervention. Trained providers must engage with women and provide this information in an interactive fashion. In an empowerment‐based model, the interaction would provide space for women to identify their own nutritional goals and articulate strategies for their achievement, that is, counseling accompanied by nutritional supplements. In turn, women would gain awareness of the importance of prenatal and postpartum nutrition, which is integral to all counseling programs, and feel motivated to act on the information they have obtained. Peer support in the form of key influencers such as grandmother, husband, and other family members and friends in the counseling sessions’ group sessions are anticipated to improve adherence to the actions addressed through counseling sessions by creating a supportive opportunity structure for pregnant women to exercise agency over their nutritional needs. Thus, we hypothesized that nutrition counseling which involves key influencers, would lead to increased motivation and resource support for behavior change, which would translate into improved attitudes and practices, such as increased adherence to the nutrition counseling intervention(s). We also hypothesized that this effect would be more pronounced with multiple opportunities for nutrition education and counseling to take place.

2.3.3. Change in behavior

In the intermediate term, these immediate outcomes would improve behavioral outcomes such as dietary intake and diversity during pregnancy and adherence to micronutrient supplementation. Change in behavior is critical on the path to impact. Nutrition counseling for pregnant women should also seek to influence their behavior with regard to accessing quality ANC services, promoting delivery at the health facility, accessing quality postnatal care services, and adequate intent and young child feeding practices (Alam et al., 2005; Girard & Olude, 2012; Perumal et al., 2013).

2.3.4. Long‐term outcomes

Nutrition counseling is anticipated to improve maternal and infant health outcomes thereby contributing to reduced risk of mortality, pregnancy complications, anemia, stillbirths, and perinatal mortality.

2.3.5. Contextual factors or mediating variables

We acknowledge there are also several factors at an individual and household level that could mediate the effectiveness of the intervention, as well as the suggested outcomes along the causal pathway (Pouchieu et al., 2013). These include a household's socioeconomic status, food security, or an individual's level of education. We applied the PROGRESS+ framework (O'Neill et al., 2014) to identify these socially stratifying factors and where possible, conducted sub‐group analyses to look at the differences in effects by group.

2.4. Why it is important to do this review

There is limited evidence on the effectiveness of nutritional education and counseling among pregnant women. A Cochrane systematic review found that such practices tended to lower the risk of preterm delivery, but had no effect on infant complications or stillbirth (Ota et al., 2015). A similar meta‐analysis of controlled experimental trials found a significant association between receiving nutritional counseling and improved gestational and birth weight, as well as reduced risk of anemia among pregnant mothers (Girard & Olude, 2012). Even though both reviews have shown that nutritional education and counseling carry the potential to positively influence the health status of both the mother and the infant, several methodological limitations in the breadth of their searches (no gray literature or equity terms searched) and selection of study designs prevented a comprehensive synthesis of knowledge around the effectiveness of such practices. To the best of our knowledge, our systematic review provides the most robust and equity‐focused analysis on the effectiveness of nutritional education and two‐way interactive counseling among pregnant women in LMICs for health and nutrition outcomes that were analyzed by the previous review as well as an additional analysis of behavioral outcomes.

Nutrition counseling and education have increased the compliance of pregnant women to dietary guidelines in high income countries (Goodarzi‐Khoigani et al., 2018). The impact of such interventions on maternal and fetal health outcomes in LMICs has not been well examined or documented. Moreover, little evidence is available on the implications that such interventions might carry on the health equity of pregnant women in such socially and economically disadvantaged settings represented by PROGRESS+ characteristics. The added value of our systematic review is to not only provide a comprehensive analysis of the effectiveness of nutrition counseling and education interventions, but also to use an equity lens in interpreting the differences in the magnitude of their effectiveness across participant characteristics. This review aimed to accelerate the progress toward SDGs set by the United Nations (Girard & Olude, 2012). Although the focus of this review was on maternal nutrition and newborns, it also investigated an interdependent relationship of gender equality/socioeconomic status with nutrition. Thus, according to our pathway, we hoped to improve equity in access to social, financial resources for women. Our review will help inform nutrition counseling programmers and policy makers about effective and equitable counseling programs to improve the health status of pregnant women and their infants in countries where malnutrition is highly prevalent.

3. OBJECTIVES

The objective of this systematic review was to identify, appraise, and synthesize the best available evidence on the effectiveness of two‐way interactive nutrition counseling on maternal and infant health outcomes, and assess the differences in effects across participants’ PROGRESS+ characteristics.

To achieve these objectives, we aimed to answer the following research questions:

What is the effect of maternal nutrition counseling during pregnancy in LMICs on maternal, infant and infant behavioral and health outcomes?
What are the documented potential effects of nutrition counseling interventions on maternal and infant behavioral and health outcomes across participants’ PROGRESS+ characteristics?

4. METHODS

4.1. Criteria for considering studies for this review

4.1.1. Types of studies

This review was conducted according to a published protocol (Dewidar et al., 2021). We conformed to the Cochrane Collaboration's Effective Practice and Organisation of Care (EPOC) criteria for the selection of studies (EPOC, 2017) as randomized trials may not be sufficiently available to address the effects of two‐way nutrition counseling on health outcomes. We included individual and cluster randomized controlled trials (RCTs), non‐randomized controlled trials (NRCTs), controlled before and after (CBA) studies as well as interrupted time series or repeated time measures studies (ITSs). We followed EPOC guidance and only included ITS with three data points before and three data points after the intervention (EPOC, 2017). We excluded cross sectional studies. Studies that did not include a control group were excluded from the review as it was difficult to attribute causation with that study design.

4.1.2. Types of participants

Participants included low risk pregnant women (15–49 years, with no active pregnancy‐related complications that required referral for additional management or specialist care) in different stages of gestation in LMICs, as defined by the World Bank country income group categories at the time of the study's conduct.

4.1.3. Types of interventions

The objective of this systematic review was to identify, appraise and synthesize the best available evidence on the effectiveness of nutrition counseling in improving maternal and infant health outcomes, and assess the differences in effect sizes across participants’ PROGRESS+ characteristics.

The primary comparison was interactive nutrition counseling versus standard ANC with no interactive nutrition counseling. Studies that compared nutrition counseling to another approach of ANC (i.e., educational booklets given to pregnant women) were included and analyzed separately.

Support could be provided in addition to counseling as follows:

1.
Providing nutritious food to malnourished individuals, based on anthropometric entry and exit criteria (low body mass index or low mid‐upper arm circumference).
2.
Providing additional nutrient supplementation (e.g., micronutrient supplements such as iron folic acid supplements).
3.
Educating individuals on a variety of activities that aimed to give them tools to meet their basic needs, including food, so that they do not have to rely on long‐term income transfers or food assistance.

The support must have been present in both study arms for the study to be included as we aimed to assess the efficacy of nutrition counseling.

4.1.4. Types of outcome measures

Studies reporting at least one of the following outcomes were included:

	Primary outcomes	Secondary outcomes
Maternal health	Mortality (up to 6 weeks postpartum)	Gestational weight gain (kg)
	Anemia (hemoglobin lower than 110 g/L) during and post counseling	Hemoglobin concentration postintervention
	Iron deficiency (as defined by study authors)	Hemorrhage (defined by study authors)
	‐	Mode of delivery (c‐section vs. vaginal)
Maternal behaviors	Intent to breastfeed (defined by study authors)	Dietary intake during pregnancy (kcal/day)
	Timely initiation of breastfeeding (proportion of women who initiated breastfeeding within 1 h of birth)	Macronutrient intake during pregnancy
	Adherence to iron containing supplement consumption (proportion of women who reportedly consumed iron supplements during pregnancy as defined by study authors)	‐
	Adherence to ANC (as reported by study authors)	‐
Infant health	Stillbirths (death after 20 week's gestation and before birth)	Low birthweight (less than 2500 g)
	Preterm birth (before 37 week's gestation)	Small for gestational Age (SGA) (as defined by study authors)
	Perinatal mortality (defined by study authors)	‐

Paper	Definition of nutrition counseling						Outcomes of Interest
Paper	How is Nutrition Counseling defined in the paper	Type (1‐1, group etc.)	Frequency (# of times in ANC)	Who provided the counseling	Where the counseling was provided	Content (diet, nutrition supplements, breastfeeding etc.)	Outcomes of Interest
Abdel‐Aziz et al. (2018)	Not reported—Tailored nutrition counseling sessions were designed based on the 1990 IOM guidelines for nutrition and weight during pregnancy. Women in the intervention group received standard care delivered at the center group and attended six extra counseling sessions with the nutrition counselor, with face‐to‐face appointments every 2 weeks during the implementation phase.	1‐1	11–15	member of the research team	ANC centers	How to control weight gain during pregnancy and how to maintain or optimize a healthy lifestyle in a period of physical and mental changes. the nutrition counselor educated participants how to choose healthier foods (whole grains, fruits and vegetables, healthy fats, and protein sources); how to limit intake of unhealthy foods (refined grains and sweets) and beverages (sugary drinks); and how to get rid of the unhealthy habits (frying food, eating fast food, skipping meals, and eating unhealthy snacks between meals) and avoid sedentary life by encouraging walking for 30 min three times per week	Anemia, gestational weight gain, mode of delivery, preterm birth
Belizan et al. (1995)	Not reported—prenatal care (standard hospital procedures) was supplemented with four to six home visits.	1‐1	4–6	Specially trained female social workers	Home visits	reducing stress and anxiety, inadequate health‐related behavior, and untimely or null recognition of pregnancy‐ and labor‐related morbidity and at increasing health services utilization.	Anemia, hemorrhage, adherence to nutrition counseling, stillbirths, Low birthweight
Nyamasege (2018)	An interactive supporting process focusing on the need for diet modification, is a widely used strategy in health facilities to improve the nutritional status of women during pregnancy	1‐1	7	Trained community health volunteers	Home visits	The specific maternal nutrition education key messages included importance of adequate diet during pregnancy, attending ANC, and taking iron and folate supplements. Other maternal health‐related key messages were on seeking early treatment for infections and how to prevent them, encouraging the use of good hygienic practices, avoiding alcohol, smoking, and nonprescription drugs, and good antenatal care.	Mode of delivery, adherence to nutrition counseling, preterm birth, low birthweight
Jahan et al. (2014)	Not reported—The nutrition education sessions were provided in a counseling format and focused on encouraging behavior change.	group	3	Trained member of the research team	Maternal health hospital	The content of the sessions included the nutritional value of food, the importance of exclusive breastfeeding, establishing an adequate diet during pregnancy and lactation, cooking practices for optimum retention of nutrients, and creating awareness about food taboos relating to pregnancy and infant feeding.	Gestational weight gain, timely initiation of breastfeeding
Jing et al. (2015)	Not reported—women in the intervention group received an education manual on diet and physical activity (written by the research team) after randomization, and one‐to‐one counseling for at least 20 min in a private room with a trained graduate student (W. J.), By contrast, pregnant women in the control group received only conventional interventions, such as standard health education manuals produced by the hospital	1‐1 & group	3	Graduate student	West China Second University	The key points of education included the harm of GWG and GDM, the benefit of encouraged behaviors, the difficulty to change habits, and the importance of belief in the efficacy of the interventions.	Gestational weight gain, Macrionutrient intake during pregnancy
Sharifirad (2013)	Not reported—Then the interview based on HBM was performed in two sessions of nutritional education (16 minuets for each session) according to nutrition educational guidelines in health care centers and live lecture, group discussion, colloquy and individual nutrition consultation for experimental group.	Group	2	female researcher	Health care centers	Not reported according to the “nutrition educational Guidelines in health care centers”	Gestational weight gain
Villalon et al. (2010)	Not reported	Group	5	Not reported	Prenatal clinics	individual nutritional advice including a personalized diet adapted to the needs of each woman and educational group sessions. Various subjects were taught such as physiological transformations related to pregnancy, recommended diet, essential nutrients, body weight, breastfeeding, the introduction of solid foods to the child and diet the nursing woman.	Gestational weight gain
Kafatos et al. (1989)	Not reported	1‐1	6–10	Trained nurse counselors	Clinics	Basics of nutrition during pregnancy for the health of mother and fetus, including food sources and nation effects of selecting a balanced diet. The women were also taught practical techniques for improving the quality of their diets. They were encouraged to consume locally grown foods that have a high nutrient value and to prepare and preserve food in such a way as to reduce the loss of nutrients.	Hemoglobin, dietary intake, stillbirths, low birthweight, small for gestational age (SGA)
Kanber et al. (2011)	Not reported	1‐1	One time	Not reported	Obstetrics and Gynecology Hospital and the University Hospital, Istanbul Turkey	Not reported	Hemoglobin concentration
Lin et al. (2020)	Structured but individually modified education regarding a balanced dietary pattern, moderate physical activity, and weight control.	1‐1	One time	Interventionist (no further detail)	Women and Children's Hospital, School of Medicine, Xiamen University, China	The balanced dietary pattern in the intervention was based on the China diagnosis and therapy guideline of pregnancy with diabetes mellitus,24 aimed to achieve or maintain ideal body weight and meet nutritional needs. Pregnant women were encouraged to consume vegetables, fruits, high‐fiber wholegrain products, low‐fat dairy products, and to avoid foods rich in sugar and saturated fatty acids, among other guidance	Gestational weight gain, Hemorrhage, Mode of delivery
Liu et al. (2009)	Not reported‐ The goals of the intervention were to provide information and guidance on contemporary postpartum practices and take away common misconceptions about traditional dietary and health behaviors (e.g., fruit and vegetables should be restricted because of cold nature, postpartum women should stay inside and not go outdoors)	Group	2	Trained health staff by the team	Clinic	The content of the two sessions focused on:	Mode of delivery, dietary intake during pregnancy (kcal/day)
Liu et al. (2009)		Group	2	Trained health staff by the team	Clinic	Food guide pyramid knowledge Nutrient‐food association knowledge The importance of dairy consumption, fruit and vegetable consumption Examples of healthy menus Optimal hygiene behavior and physical exercise patterns during postpartum period Discussions about healthy lifestyle during postpartum period Common misconceptions on hygiene behaviors during puerperium Discussions about nutrition and health problems concerns postpartum practices
Zhou & Tang (2020)	Not reported—individualized nutritional care	1‐1	One time	Experts from the Nutrition Department, West China Second University Hospital, Sichuan University/West China Women's and Children's Hospital	Hospital	The daily caloric requirement in the first trimester and the second and third trimester, in which protein accounted for 25%, carbohydrates accounted for 55% and fat accounted for 20% of the die, while consuming 5–6 meals a day. Adherence to low salt and low sugar diets.	Hemorrhage
Kian et al. (2016)	Not‐reported—face‐to‐face training	1‐1 & group	2	Tehran University of Medical Sciences	Hospital	Training items mentioned in the first session of the training were included; a definition of gestational diabetes, causes, side effects, individuals at risk, and control and treatment of gestational diabetes such as glycemic control. Training items that were taught in the second session were included; nutrition, physical activity and exercise, insulin injection, and following‐up after the pregnancy.	Mode of delivery

Maternal health outcomes of interest	Paper	Inclusion criteria	Exclusion criteria	What trimester was the maternal health outcome measured? (i.e., anemia, gestational weight)	What was the nutrition intervention? (i.e., counseling on Macronutrient intake, counseling on IFA)	What was the change from the intervention (unit: effect size)
Anemia	Abdel‐Aziz et al. (2018)	primigravidae aged between 20 and 30 years in the first trimester (<12 weeks of gestation) of selected ANC clinic, free from history of any chronic medical problems	younger than 18 years, have a history of previous abortion or stillbirth, presence of any chronic disease, and taking any type of medications that might interfere with the bodyweight (steroids, diuretics, and thyroid hormones).	Third trimester	Prevention of excessive GWG, healthy eating	RR: 0.45 [0.22, 0.93]
	Belizan et al. (1995)	Women initiating prenatal care between the fifteenth and twenty‐second weeks of gestation with singleton pregnancies;, with at least one of the following risk factors: (1) previous low‐birth‐weight or infant death; (2) previous fetal, neonatal or infant death (3) <17 years old; (4) body weight < 50 kg and height < 1.5; (5) low family income defined by locally adapted cutoff points; (6) <3 years of schooling; (7) smoking or heavy alcohol consumption; and (8) single, separated, divorced or widowed.	With clinical evidence of cardiovascular, renal, or other chronic diseases; history of cerclage. Rh‐negative, or mental diseases	Third trimester	healthy eating, support during pregnancy	RR: 1.03 [0.85, 1.25]
	Nyamasege (2018)	Pregnant women were prospectively included throughout the trimesters, residents of two densely populated slums (Korogocho, and Viwandani) located 7 km apart from each other.	Women of reproductive age who were to deliver before the intervention started	Third trimester	Knowledge of pregnancy complications, importance of taking iron and folate supplements.	RR: 0.72 [0.45, 1.17]
Gestational weight gain (kg)	Aşcı & Rathfisch (2016)	Pregnant women aged over 18, who had no health problems, did not intend to lose weight in pre‐pregnancy period, got pregnant in natural ways for two times at most, and were pregnant for a period of 3 months or less, were included in the study	Pregnancy complications	Third trimester	Pregnancy weight gain, healthy eating	MD (kg): 0.16 [−1.75, 2.07]
	Jahan et al. (2014)	Women at a gestational age of 24 weeks attending the government Maternal and Child Health Training Institute, Azimpur, and the Marie Stopes Clinic, Bashbari, Dhaka	Complications and special requirements	Third trimester	Pregnancy weight gain, adequate food intake, and breastfeeding for the newborn	MD (kg): 1.03 [−1.79, 3.85]
	Jing et al. (2015)	Women aged at least 18 years, could understand the written Chinese language, and did not have pre‐existing diabetes	pregnancy‐related complications or general medical disorders not associated with pregnancy	Second trimester	Pregnancy weight gain	MD (Kg): −0.45 [−1.40, 0.50]
Gestational weight gain (within recommendations)	Sharifirad (2013)	Pregnant women who were resided in Gonabad and went to urban health care centers for prenatal care	‐	Third trimester	No information reported	RR: 1.92 [1.37, 2.71]
Gestational weight gain (within recommendations)	Villalon et al. (2010)	Women were between 19 and 30 years old, first month of gestation, attended one of the prenatal clinics in the Cotonou region, did not consume any form of tobacco, never experienced a previous pregnancy.	‐	Third trimester	Healthy eating, pregnancy weight gain, breastfeeding	RR: 1.35 [0.38, 4.76]
Hemoglobin concentration	Kafatos et al. (1989)	Women residing in the market towns and villages of Florina, Greece	‐	Third trimester	Healthy eating	MD (mmol/L): −0.05 [−0.05, −0.05]
Hemoglobin concentration	Kanber et al. (2011)	Women in 3rd month of pregnancy	Pregnant women with chronic anemia, chronic kidney disease, parasitic disease, and illiterate people were not included in the study.	Third trimester	No information reported	MD (mmol/L): 0.10 [−0.39, −0.59]
Hemorrhage	Belizan et al. (1995)	Women initiating prenatal care between the 15th and 22nd weeks of gestation with singleton pregnancies;, with at least one of the following risk factors: (1) previous low‐birth‐weight or infant death; (2) previous fetal, neonatal or infant death (3) <17 years old; (4) body weight < 50 kg and height < 1.5; (5) low family income defined by locally adapted cutoff points; (6) <3 years of schooling; (7) smoking or heavy alcohol consumption; and (8) single, separated, divorced or widowed.	With clinical evidence of cardiovascular, renal, or other chronic diseases; history of cerclage. Rh‐negative, or mental diseases	Third trimester	Healthy eating, support during pregnancy	RR: 0.82 [0.51, 1.31]
	Lin et al. (2020)		Pregnant women with pre‐existing diabetes mellitus, multiple pregnancies, use of medication that influences glucose metabolism (e.g., steroids, b‐adrenergic agonists, and anti‐psychotic drugs), physical disability, or severe psychiatric disorders.	Second or third trimester of pregnancy	Healthy eating, exercise	RR: 0.26 [0.10, 0.66]
	Zhou & Tang (2020)	According to the diagnostic methods and standards of IADPSG 2010, fasting plasma glucose (FPG) ‚ ≥5.1 mmol/L when first examined at 24–28 weeks of pregnancy could be diagnosed as GDM.	(1) Twin or multiple pregnancies; (2) combined with other metabolic diseases such as thyroid dysfunction, abnormal secretion of adrenaline or adrenocorticotropic hormone or growth hormone; (3) combined with other diseases.	Postpartum (after delivery)	No information reported	RR: 0.29 [0.06, 1.31]
Cesarean section delivery	Abdel‐Aziz et al. (2018)	Primigravidae aged between 20 and 30 years in the first trimester (<12 weeks of gestation) of selected ANC clinic, free from history of any chronic medical problems were recruited to participate.	Women were not eligible for participation if they were younger than 18 years (to avoid natural linear growth), having a history of previous abortion or stillbirth, presence of any chronic dis‐ease, and taking any type of medications that might interfere with the bodyweight (steroids, diuretics, and thyroid hormones).	Delivery	Weight gain, eating healthy	RR: 0.48 [0.24, 0.95]
	Aşcı & Rathfisch (2016)	Pregnant women aged over 18, who had no health problems, did not intend to lose weight in pre‐pregnancy period, got pregnant in natural ways for two times at most, and were pregnant for a period of 3 months or less, were included in the study	Pregnancy complications	Delivery	Pregnancy weight gain, healthy eating	RR: 1.13 [0.64, 2.02]
	Lin et al. (2020)	Adult pregnant women aged 18 years or older who had at least one risk factor of GDM were included in this study. The risk factors of GDM were defined as follows: age ≥ 35 years, pre‐pregnancy body mass index (BMI) ≥ 25 kg/m², family history of diabetes mellitus, history of PCOS, and history of GDM in a previous pregnancy.	Pregnant women with pre‐existing diabetes mellitus, multiple pregnancies, use of medication that influences glucose metabolism (e.g., steroids, b‐adrenergic agonists, and anti‐psychotic drugs), physical disability, or severe psychiatric disorders.	Delivery	Healthy eating, exercise	RR: 0.72 [0.54, 0.96]
	Liu et al. (2009)	1) healthy pregnant women; 2) at their third trimester; 3) had at least three routine examinations at these antenatal clinics.	1) over 35 years of age; 2) had pregnancy complications such as cardiovascular, digestive, endocrine and reproductive system diseases; 3) had multiple gestations; and 4) could not have a vaginal birth because of predisposing factors such as an abnormal pelvis, malposition, or uterine fibroids.	Delivery	Healthy eating, diversity	RR: 0.99 [0.79, 1.25]
	Nyamasege (2018)	Pregnant women were prospectively included throughout the trimesters, residents of two densely populated slums (Korogocho, and Viwandani) located 7 km apart from each other.	Women of reproductive age who were to deliver before the intervention started.	Delivery	Knowledge of pregnancy complications, importance of taking iron and folate supplements	RR: 1.04 [0.80, 1.35]

Paper	Maternal behavior outcomes of interest	Exclusion criteria	What trimester was maternal health measured? (i.e.)	What was the nutrition intervention? (i.e., counseling on dietary diversity, counseling on IFA)	What was the change from the intervention?
Aşcı & Rathfisch (2016)	Dietary intake	Pregnancy complications	Second trimester	Pregnancy weight gain, healthy eating	Mean difference of 199.00 calories [−43.15, 441.15] from control (standard ANC)
Jing et al. (2015)	Dietary intake	Pregnancy‐related complications or general medical disorders not associated with pregnancy	Second trimester	Pregnancy weight gain	Mean difference of 125.34 calories [26.67, 224.01] from control (standard ANC)
Liu et al. (2009)	Dietary intake	‐	6 weeks after delivery	Healthy eating, exercise, support	Mean difference of 51.27 calories [30.06, 72.48] from control (standard ANC)
Aşcı & Rathfisch (2016)	Macronutrient intake—Protein	Pregnancy complications	Third trimester	Pregnancy weight gain, healthy eating	Mean difference of 14.70 g [12.87, 16.53] from control (standard ANC)
Jing et al. (2015)	Macronutrient intake—Protein	Pregnancy‐related complications or general medical disorders not associated with pregnancy	Second trimester	Pregnancy weight gain	Mean difference of 5.91 g [2.37, 9.45] from control (standard ANC)
Aşcı & Rathfisch (2016)	Macronutrient intake—Fat	Pregnancy complications	Third trimester	Pregnancy weight gain, healthy eating	Mean difference of 7.00 g [−2.01, 16.01] from control (standard ANC)
Jing et al. (2015)	Macronutrient intake—Fat	Pregnancy‐related complications or general medical disorders not associated with pregnancy	Second trimester	Pregnancy weight gain	Mean difference of 2.73 g [−1.23, 6.69] from control (standard ANC)
Aşcı & Rathfisch (2016)	Macronutrient intake—carbohydrates	Pregnancy complications	Third trimester	Pregnancy weight gain, healthy eating	Mean difference of 18.50 g [−20.75, 57.75] from control (standard ANC)
Jing et al. (2015)	Macronutrient intake—carbohydrates	Pregnancy‐related complications or general medical disorders not associated with pregnancy	Second trimester	Pregnancy weight gain	Mean difference of 19.12 g [1.09, 37.41] from control (standard ANC)

Infant health outcomes of interest	Paper	Exclusion criteria	What was the nutrition intervention? (i.e., counseling on Macronutrient intake, counseling on IFA)	What was the change from the intervention (Unit: effect size)
Stillbirths	Belizan et al. (1995)	With clinical evidence of cardiovascular, renal, or other chronic diseases; history of cerclage. Rh‐negative, or mental diseases	Nutrition during pregnancy, support during pregnancy	RR: 0.89 [0.55, 1.44]
	Kafatos et al. (1989)	Not reported	Nutrition during pregnancy	RR: 0.45 [0.11, 1.77]
	Kian et al. (2016)	Women who received diabetes training before entering the study.	Knowledge of pregnancy complications	RR: 0.33 [0.01, 7.96]
Preterm birth	Abdel‐Aziz et al. (2018)	younger than 18 years, have a history of previous abortion or stillbirth, presence of any chronic disease, and taking any type of medications that might interfere with the bodyweight (steroids, diuretics, and thyroid hormones).	Prevention of excessive GWG, healthy eating	RR: 0.84 [0.68, 1.04]
Preterm birth	Nyamasege (2018)	women of reproductive age who were to deliver before the intervention started	Knowledge of pregnancy complications, importance of taking iron and folate supplements	RR: 0.39 [0.17, 0.88]
Low birthweight	Belizan et al. (1995)	With clinical evidence of cardiovascular, renal, or other chronic diseases; history of cerclage. Rh‐negative, or mental diseases	Nutrition during pregnancy, support during pregnancy	RR: 0.92 [0.70, 1.21]
	Kafatos et al. (1989)	Not reported	Nutrition during pregnancy	RR: 1.14 [0.51, 2.56]
	Nyamasege (2018)	women of reproductive age who were to deliver before the intervention started	Knowledge of pregnancy complications, importance of taking iron and folate supplements	RR: 0.37 [0.20, 0.71]

Outcome	N RCTs	ITT (risk ratio M‐H, random, 95% CI)	Per protocol (risk ratio M‐H, random, 95% CI)
Anemia	3	0.77 [0.50, 1.20]	0.76 [0.48, 1.20]
Gestational weight gain within recommendations	3	1.84 [1.10, 3.09]	1.81 [1.10, 2.98]
C‐section delivery	5	0.89 [0.71, 1.10]	0.91 [0.71, 1.16]
Hemorrhage	3	0.44 [0.18, 1.10]	0.45 [0.18, 1.09]
Stillbirths	3	0.81 [0.52, 1.27]	0.81 [0.51, 1.27]
Preterm births	2	0.63 [0.31, 1.31]	0.62 [0.29, 1.33]
Low birthweight	3	0.74 [0.40, 1.37]	0.74 [0.40, 1.36]

Methods	Individual Randomized Controlled Trial in family health center in Istanbul, Turkey
Participants	Inclusion criteria: Pregnant women aged over 18, who had no health problems, did not intend to lose weight in pre‐pregnancy period, got pregnant in natural ways for two times at most, and were pregnant for a period of 3 months or less, were included in the study. Exclusion criteria: Six people from intervention and control groups were excluded from the study due to reasons such as not coming to regular follow‐ups and pregnancy complications. Age [Mean (SD)]: ‐ Intervention, Control: 24.31 (4.22), 24.28 (4.15) Working status [n (%)]:‐ Intervention, Control: 7 (15.6), 2 (4.4) Education mean (years): ‐ Intervention, Control: 6.6 (2.8), 7.6 (3.2) Income [n (%)]:‐ Intervention, Control: Low: 15 (33.3), 11 (24.4) Middle: 30 (66.7), 34 (75.6) High: 0, 0
Interventions	Intervention—Lifestyle intervention (n = 51) Description: Four meetings were held with women regarding healthy lifestyle, nutrition, exercise, and weight follow‐up. At every meeting, objectives of nutrition and physical activity for optimal GWG were specified until the next meeting. Women reaching their objectives were praised and encouraged. Nutrition and physical activity levels of women who could not reach their objectives were reviewed with women, and a more intensive consultancy (repetition of basic nutrition and physical activity recommendations, reviewing individual objectives, and supportive phone consultancy) was provided. Interviews made in weeks 12–15, 16–18, and 20–24, a 15‐min health training prepared in the computer was carried out and then brochures were delivered. Each of these interviews lasted for about 1 h. In gestational weeks 12–15, the women were interviewed regarding the importance of healthy life and health practices. In gestational weeks 16–18, inter‐views were held concerning physical activity and exercises. Low‐level aerobic exercises recommended for pregnancy were shown and performed. Women were recommended to do mild‐moderate safe exercise types, which increase the heart rate to maximum 140 beats/min while being easily able to talk, for 30 min every other day (elliptical trainer, swimming, pilates, yoga, golf adapted for pregnancy, and mild level aerobic exercises), and maintain a more active lifestyle (taking walks every day, going to work by walking, using stairs instead of elevators, participating in sportive activities in their leisure times). In gestational weeks 20–24, interviews regarding nutrition were held. Women were informed about the basic nutrition principles (eating small but frequent meals at least 5 times a day, having breakfast every day, portions and amounts required to be consumed from all food groups, lessening consumption of sweet foods to once a day or less, increasing fibrin intake from bread, and decreasing fat in diet). Recommendations for consuming more healthy foods (e.g., fruit) instead of foods containing intensive energy (e.g., fast food and sweets) without any energy limitation according to the personal dietary habits were given. In week 37, only weights were followed up. Nutrition counseling messaging: Pender‚ health promotion model was used to allow women to express their experiences and opinions through open‐ended questions, e.g., what problems (barriers) you may have to eat healthier foods (more vegetables, more fruits, lower‐fat foods, and healthy grains), regarding nutrition and physical activity. Therefore, counseling, and behavioral skill‐building interventions were personalized according to the barriers for the individuals to displaying the behavior and their self‐efficacies in terms of performing the behavior. Women were informed about the importance of gaining weight within the recommended range and maintaining a healthy life. Intervention adapted to local context: Not reported Women empowerment approach: Partial empowerment model Control (n = 51) Description: Women are generally followed up by at least four times by midwives or nurses in standard care. In every follow‐up, weights of women are measured; however, they are not informed on what the GWG range appropriate for their BMI is and their personal weight changes.
Outcomes	Gestational weight gain, mode of delivery, Dietary intake during pregnancy, Macronutrient intake during pregnancy,
Notes	Funding: This study did not receive grant from any institution or organization.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Low risk	The women were divided into randomized groups by a staff who was not involved in this study, by drawing lots (control n = 51, intervention = 51).
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Low risk	Participants were blind about which group they were involved in and the evaluated study outcomes. Groups were interviewed at different times and in different rooms in the center to control the interaction between groups.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Low risk	Participants were blinded and carers were possibly not aware of the two groups. No information on failure to implement the intervention or issues of adherence.
Missing outcome data	Some concerns	Two participants discontinued in the intervention group, but not in the control group
Risk of bias in measurement of the outcome	Low risk	Outcomes measured using calibrated instruments, measured twice and mean was calculated.
Risk of bias in selection of the reported result	Low risk	All outcomes measured as stated in methods with defined tools.

Methods	Individual Randomized Controlled Trial of pregnant women in ANC clinic, Center for Social and Preventive Medicine (CSPM), Pediatrics Hospital, Cairo University, Cairo Egypt
Participants	Inclusion: Primigravidae aged between 20 and 30 years in the first trimester (<12 weeks of gestation) of selected ANC clinic, free from history of any chronic medical problems were recruited to participate. Exclusion: Women were not eligible for participation if they were younger than 18 years (to avoid natural linear growth), having a history of previous abortion or stillbirth, presence of any chronic dis‐ease, and taking any type of medications that might interfere with the bodyweight (steroids, diuretics, and thyroid hormones). Social Score [n (%)]—Intervention, Control: Low<8: 1(1.2%), 2(2.5%) Intermediate (8–18): 74(92.5%), 74(92.5%) High (19–28): 5(6.3%), 4(5%)
Interventions	Intervention—Dietary counseling (n = 80) Description: The nutrition counselor who was a member of the research team discussed with the participants how to control weight gain during pregnancy and how to maintain or optimize a healthy lifestyle in a period of physical and mental changes. Each counseling session took about 20 min, except for the first session, which took approximately half an hour; the counselor explained the aim of the study and the intervention again. Participants of both groups received information on the recommendations of IOM7 for total GWG. Nutrition counseling messaging: Dietary counseling focused on the main topics considered important in the prevention of EGWG. The following dietary objectives were set for each participant to achieve or to maintain her body weight, having regular meal patterns based on the dietary guidelines for healthy pregnant women with considerations on the importance of dietary elements taken during pregnancy. Aiming to improve dietary practices, on five food groups of the food guide pyramid. Intervention adapted to local context: Not reported Women empowerment approach: Unclear Control (n = 80) Description: Standard care during routine ANC
Outcomes	Anemia, Gestational weight gain, Mode of delivery, Preterm Birth
Notes	Funding: None declared.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Some concerns	Randomized allocation but no information on allocation concealment. There was no significant differences at baseline.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	No information on blinding of participants or personnel.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	High risk	“A considerable number of participants were illiterate, educational materials were taught, and a copy of written materials was provided to illiterate participants, who were advised to get help at home by their educated spouse. Unfortunately, dropouts at the end of the study endorse difficulty in follow‐up of the studied participants throughout the pregnancy until labor.”
Missing outcome data	Low risk	Data was reported for most participants.
Risk of bias in measurement of the outcome	Unclear risk	No information provided.
Risk of bias in selection of the reported result	Low risk	All outcomes measured as stated in methods with defined tools.

Methods	Non‐randomized controlled study of pregnant women receiving antenatal care in public health center in Amman, Jordan
Participants	Inclusion criteria: Jordanian pregnant women, aged 18–40 years, and in the first or second trimesters. Exclusion criteria: Pregnant women with any medical problems or chronic diseases during pregnancy such as gestational diabetes, pre‐eclampsia, hypertension, or coronary heart disease to exclude the effect of other factors on the study outcomes. Age [Mean (SD)]: 28.38 (6.18) Monthly family income [Mean (SD)]—Intervention, Control: 490.32 (277.31), 451.60 (235.16) Parity [Mean (SD)]—Intervention, Control: 2.66 (2.04), 2.37 (2.23)
Interventions	Intervention—Health education (n = 108) Description: pretest structured questionnaires were completed face‐to‐face before the conduction of onsite educational sessions on six occasions and the posttest only was collected using phone calls after 6 weeks. It took 15–20 min to complete the questionnaires. At each visit, the nurse researcher gathered the assigned subgroup of 15–18 pregnant women in the meeting room where pretest structured questionnaires were completed. Then, one educational lecture was delivered for that group. At the end of the lecture, brochures were distributed to support the explained lecture. The researcher used WhatsApp application after that to communicate added information about dietary knowledge and practices to women at home using tips and videos. The researcher answered all questions by participants using phone calls or through text messages. After 6 weeks, the posttest was collected from all subgroups using phone calls. The nurse implemented an interactive lecture using PowerPoint presentations and discussions with participants to increase the level of dietary knowledge and practices. Nutrition counseling messaging: benefits of a healthy diet and using interactive learning are among the successful nutrition interventions. Examples of the topics covered are the physiological changes that occur in pregnant woman, the importance of diet and supplements for pregnant women and the fetus, the six categories of nutrition, the daily needs of diet during pregnancy, the normal weight gained during pregnancy, and the body mass index categories and its calculation. The teaching materials were adopted from ‚Healthy Eating during Pregnancy and Breastfeeding Nutrition of Women in the Preconception Period, during Pregnancy and the Breastfeeding Period and Diet during Pregnancy: Healthy Eating While Pregnant. Intervention adapted to local context: Minor modifications [questionnaire] were made to accommodate the Jordanian culture and achieve the study purpose. Women empowerment approach: Unclear Control (n = 108) Description: The control group received usual antenatal care in the two other health centers. No questions or discussions were opened about dietary knowledge and practices during pregnancy with the control group.
Outcomes	No outcomes of interest reported.
Notes	Funding: This study was funded by the Deanship of Research in Jordan University of Science and Technology.

Bias	Author's judgment
Representativeness of the exposed cohort	Somewhat representative of the average population of pregnant women in the community *
Selection of the nonexposed cohort	Drawn from the same community as the exposed cohort*
Ascertainment of exposure	Structured interview*
Demonstration that outcome of interest was not present at start of study	Yes*
Comparability of cohorts based on the design or analysis	Secure record (eg surgical records)*
Assessment of outcome	No description
Was follow‐up long enough for outcomes to occur	Yes*
Adequacy of follow up of cohorts	Complete follow up ‐ all subjects accounted for*

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	High Risk	Quasi‐randomized
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	Study conducted in the health centers so carers are likely to know about the intervention.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	No information on blinding of participants or deviations that arose.
Missing outcome data	Low risk	Almost all the participants were included in the analysis, with no difference in dropouts between groups.
Risk of bias in measurement of the outcome	Low risk	Used structured questionnaire to collect outcome data. No information on awareness of outcome assessors.
Risk of bias in selection of the reported result	Low risk	All outcomes reported as specified in the methods.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Low risk	A computer‐generated randomization code was used with balanced blocks of 20 women and stratified by center. A sequence of sealed opaque envelopes was used by a single investigator to assign women to intervention groups
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	Clinic personnel were not made aware of the assigned intervention, but some women may have informed them. Due to the nature of the intervention participants were not blinded to assignment during the trial. The data were analyzed on an intention to treat basis.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	Adhering to the intervention was not assessed by the investigators. A special support office was created for women in the intervention group to encourage compliance, but adherence rates were not reported.
Missing outcome data	High risk	There are around 100 drop‐outs from each study arm, but missingness was not mentioned and no analysis to address this issue was conducted.
Risk of bias in measurement of the outcome	Low risk	Data for the treatment effects were collected by a team of independent professional interviewers who were not informed about the nature of the study.
Risk of bias in selection of the reported result	Low risk	data that produced this result was analyzed in accordance with a pre‐specified analysis plan that was finalized before unblinded outcome data were available for analysis.

Methods	Non‐randomized Controlled Study, health facility in Bharuch district in Gujarat state, India
Participants	Inclusion criteria: Pregnant women with low BMI are defined as those pregnant women whose weight/height is less than 18.5 in the first trimester as on their ANC registration. Exclusion criteria: Not reported Age [Mean (SD)]—Intervention, Control: 23.2 (3.4), 24.8 (3.7)
Interventions	Intervention—nutrition education (n = 54) Description: In the intervention group, pregnant women with low BMI received nutrition education based on a field‐tested flipbook along with demonstration sessions on handwashing and meal preparation for a mean of 18 h over 9 months. Pregnant women in the intervention group were then educated and followed up by a health volunteer from their own community at random to ensure that they practice minimum meal frequency and diversity. Effect of nutrition education was assessed based on the practice of minimum meal frequency (3 meals a day), adoption of dietary diversity through 24‐h recall method, the proportion of change evidenced in handwashing practice and mean weight gain in the third trimester. Nutrition counseling messaging: information on food frequency and dietary diversity. Intervention adapted to local context: Not reported Women empowerment approach: Unclear empowerment approach Control (n = 46) Description: the non‐intervention group received regular entitlements through ICDS.
Outcomes	Gestational weight gain, low birth weight
Notes	Funding: No funding sources

Methods	Cluster Randomized Controlled Trial of 3 woredas (clusters) in West Gojjam zone (Bahir Dar Zuria, South Achefer, and Burie Zuria Woredas), Ethopia
Participants	Inclusion criteria: Pregnant women before 16 weeks of gestation who had planned to stay in the study area until delivery were enrolled in this trial. Exclusion criteria: Women without hypertension or diabetes mellitus. Age [n (%)]—Intervention, Control: Age < 20: 25 (8.0), 16 (4.8) 20–24: 53 (16.9), 74 (22.3) 25–29: 103(32.9), 87(26.2) 30–34: 74(23.7), 84(25.3) ≥35: 58 (18.5), 71 (21.4) Housewife [n (%)]—Intervention, Control: 149 (47.6), 183 (55.1) Religion [n (%)]—Intervention, Control: Muslim: 2 (0.6), 2 (0.6) Orthodox: 311 (99.4), 330 (99.4) No formal education [n (%)]—Intervention, Control: 260 (83.1), 262 (78.9) Socioeconomic status [n (%)]—Intervention, Control: Poorest: 56 (17.9), 60 (18.0) Poor: 72 (23.0), 67 (20.2) Medium: 65 (20.8), 62 (18.7) Rich: 56 (17.9), 78 (23.5) Richest: 64 (20.4), 65 (19.6) Family size [n (%)]—Intervention, Control: < 5: 215 (68.7), 240 (72.3) ≥5: 98(31.3), 92(27.7)
Interventions	Intervention—Community‐based guided counseling (n = 346) Description: The first counseling was given before 16 weeks of gestation, focused on basic nutrition, food groups, food selection, preparation, meal frequency, portion size, and iodized salt utilization. The second and third sessions of the counseling were given during the second trimester of pregnancy and covered the whole contents of the counseling guide. The last counseling was given based on the identified gaps during the early third trimester of pregnancy. Leaflets with the core messages in Amharic (local language) and appropriate pictures were prepared and delivered to each pregnant woman in the intervention arm. For women who could not read, anyone at home or in the neighborhood who could read was requested to read the leaflet to the woman and other family members. Nutrition counseling messaging: The core contents of the counseling guide were increasing meal frequency and portion size with increasing gestational age. Message on taking diversified meals by giving emphasis to iron‐rich foods, animal products, fruits, and vegetables was also one a component of the counseling guide. Messages on the consumption of iron/folic acid supplements and iodized salt were also included in the core contents of the counseling guide. Additional messages of the core contents were reducing heavy workload, taking day rest, impregnated bed net use and utilization of health care services. Intervention adapted to local context: During counseling, counselors used a client‐centered approach to identify women, their dietary practices and their specific needs in terms of nutrition. Leaflets with core messages in Amharic (local language) and appropriate pictures were prepared and delivered to each pregnant woman in the intervention group. Women empowerment approach: Unclear empowerment approach. Control (n = 332) Description: Women in the control group received nutrition education given by the health system. Pregnant women from both the control and intervention groups attended (antenatal clinic) ANC services.
Outcomes	Macronutrient intake during pregnancy
Notes	Funding: This research was funded by Bahir Dar University.

Methods	Quasi‐randomized Controlled Study, Home visit/Community based in Anganwadi centers (AWCs) of the village, India
Participants	Inclusion criteria: pregnant women belonging to low‐SES and in varied periods of gestation ranging from completing their 5th month to completing their 9th month of gestation. Exclusion criteria: not reported. Age [Mean (SD)]: 24.46 (4.1) Literacy: More than half (57%) of the subjects were illiterate Income: The average per capita income was Rs. 699.5.
Interventions	Intervention—Nutrition education (n = 50) Description: The individualized counseling sessions ranged from about 30–40 min at the start of the intervention, where the subjects were asked to follow certain behaviors based on the lacunas identified at baseline. This was followed by weekly home visits to reinforce the messages, listen to subjects’ problems and check the compliance which included checking the IFA tablet strips and cross‐checking with family members if the subject was following the emphasized behaviors. The counseling sessions at the mid‐intervention lasted to about 20–30 min where the messages were again reinforced based on subjects’ 24‐h dietary recall, FFAQ and weight gain. Finally, towards the end of the intervention, the sessions lasted to about 15–20 min for further reinforcement. Monthly weighing of the subjects proved to be a motivating factor and helped to reinforce the messages. Whenever possible, the family members especially the husband and the mother‐in‐law of the subject were also encouraged to take extra care of the subject. Nutrition counseling messaging: (1) increasing quantity of food; (2) improving the quality of food; (3) promoting consumption of iron‐folic acid (IFA) tablets (4) rest during pregnancy; (5) Injection tetanus toxoid (TT) immunization and antenatal checkups (ANC) (getting 2 TT injections immunization completed at an interval of 1 month from ANM or doctor, undergoing periodic health check‐ups for weight gain, blood pressure and anemia)and (6) use of iodized salt (using iodized salt in all food preparations). Intervention adapted to local context: Not reported Women empowerment approach: Unclear empowerment approach. Control (n = 50) Description: The late‐gestation group without any intervention was referred to as non‐NE group for comparisons.
Outcomes	Anemia, Hemoglobin concentration, Adherence to Iron supplement consumption, Dietary intake during pregnancy
Notes	Funding: Not reported

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	High risk	This was a quasi RCT with participants allocated to study arms without randomization or concealment
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	Because of the nature of the intervention, participants and personnel were not blinded to the intervention assignment during the trial, but No reporting of any deviations from the intended intervention due to the trial context.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	The intervention seems to have been implemented properly but no discussion of challenges in implementation, but their statistical analysis was not weighted to adherence and did not consider attrition rates.
Missing outcome data	High risk	Data for this outcome was not available for all participants and no analysis to address this issue was conducted.
Risk of bias in measurement of the outcome	Low risk	The method of measuring the outcome was appropriate but the assessment of the outcomes could have been influenced by knowledge of intervention assignment.
Risk of bias in selection of the reported result	Low risk	All their analysis plans were prespecified before data was available.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	High risk	Randomization occurred in consecutive order at the time of enrollment.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Low risk	Midwives and physicians were blinded to the subject randomization and the educational content of the study to prevent contamination. Computer‑generated codes were sealed in consecutively numbered opaque envelopes and concealed from the investigator by a responsible person who had no other involvement in the study.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Low risk	Participants and carer were not aware of the intervention.
Missing outcome data	High risk	Outcome data were not available for all participant, and it is likely that missingness in the outcome depends in its true value since women dropping from the intervention group.
Risk of bias in measurement of the outcome	Low risk	The outcome was measured using a standardized Pender construct.
Risk of bias in selection of the reported result	Low risk	All the reported measures belong to the Pender construct.

Methods	Non‐randomized Controlled Study in Salak and Dengkil health clinics, Sepang District, Malaysia
Participants	Inclusion criteria: The sampling population is pregnant women in both clinics diagnosed as having anemia in pregnancy with Hemoglobin(Hb) levels of less than 11.0 g/dL and meet all the inclusion criteria. Subjects who met the following inclusion criteria were selected: Malaysian, singleton pregnancy, Hb level between 7.0 and 11 g/dL, came for antenatal booking before 24 weeks of pregnancy and wished to continue her antenatal check‐up at these clinics. Exclusion criteria: Known cases of anemia secondary to hematological disorders, women with severe anemia (Hb < 7 g/dL) and twin pregnancies were excluded. Age [Mean (SD)]—Intervention, Control: 30.1 (4.84), 29.23 (5.05) Race/Ethnicity [n (%)]—Intervention, Control: Malay: 57 (70.3), 62 (76.5) Chinese: 8 (9.9), 1 (1.2) India: 12 (14.8), 14 (17.3) Others: 4 (4.9), 4 (4.9) Employment status [n (%)]—Intervention, Control: Working: 58 (54.7), 48 (45.3) Not working: 23 (41.1), 33 (58.9) Education level (Finished sec school) [n (%)]—Intervention, Control: 50 (56.2), 39 (43.8) Income [n (%)]—Intervention, Control: 0–2999: 49 (51.6), 46 (48.4) 3000 and above: 32 (47.8), 35 (52.2)
Interventions	Intervention—HBM‐based health education intervention (n = 81) Description: The intervention program was developed through the process of consultations with a group of experts including two public health specialists and one family medicine specialist, studying the relevant literature and received opinions from the community being served. The health talk was given once for each participant during the intervention period in the form of power point presentation for about 1 h. The second activity of the health education intervention programme was as small group discussions. This was conducted and facilitated by the researcher between two to 4 weeks after the health talk. The participants were divided into nine small groups with eight to ten participants in one group. Each group participated one session during the intervention period based on timing of the participants. This activity dealt with the issues to enhance the compliance towards iron supplementation and to increase the dietary iron intake by identifying barriers towards anemia preventive behaviors. The participants were also provided with a checklist on compliance for iron supplementation. The materials used in the health education intervention programme were posters and pamphlets. Nutrition counseling messaging: The HBM‐based program addresses four major components for compliance with recommended health action: perceived barrier of recommended health action, perceived benefits of recommended health action, perceived susceptibility of the disease and perceived severity of the disease. The health talk, given by the researcher, was on topics such as introduction to anemia in pregnancy, predisposing factors, signs and symptoms, complications, prevention of anemia in pregnancy, knowledge of the wrong perception of anemia and iron supplementation, misperception about protein‐rich food and food taboos during pregnancy, and knowledge of the various sources of food that contain high iron. The pamphlet also helped to deliver take‐home messages to the participants about anemia in pregnancy. It was covered the information regarding the definition, causes, complications, and prevention of anemia in pregnancy and examples of food rich of iron. These materials were also aimed to maintain adherence towards anemia preventive behavior. Intervention adapted to local context: Not reported Women empowerment approach: Unclear empowerment approach. Control (n = 81) Description: Regular treatment.
Outcomes	Hemoglobin concentration, Adherence to Iron supplement consumption,
Notes	Funding: This research was funded by the Putra IPS Grant (GP‐IPS/2017/9576900) from Universiti Putra Malaysia.

Methods	Individual Randomized Controlled Trial, health centers in Iranshahrm Baluchistan region, Iran
Participants	Inclusion criteria: first pregnancy, wanted pregnancy, first marriage, monogamy, aged between 18 and 35 years, being in the second trimester of pregnancy, residence in the city of Iranshahr, having health care records, and being healthy. Exclusion criteria: Exclusion criteria included abortion, being transferred to another city and nonattendance in the training sessions. Age [Mean (SD)]: ‐ Intervention, Control: 20.78 (2.18), 2.1 (2.97) Occupation [n (%)]: ‐ Intervention, Control: Housewife: 71 (91.1), 70 (93.3) Employee: 69 (8.88), 50 (6.66) Education [n (%)]: ‐ Intervention, Control: 0–6 years (primary): 24 (31.11), 28 (37.77) 7–12 years (secondary): 28 (35.55), 33 (44.44) >12 years (college): 26 (33.33), 13 (17.77) Income [n (%)]: ‐ Intervention, Control: Very low (140$<): 45 (57.77), 50 (66.66) Low ($140 to $280): 21 (26.66), 17 (22.22) Average (280$>): 12 (15.55), 8 (11.11)
Interventions	Intervention—Educational intervention (n = 78) Description: The educational intervention comprised three sessions of 50 to 60 min each, using lectures, question and answers, group discussion, and role playing also benefiting from reliable sources of the Ministry of Health, Education. The control group received routine training at the care centers. Nutrition counseling messaging: The first session of the educational intervention included introduction to prenatal care, the right time to start prenatal care, hygiene, danger signs, frequently occurring disorders and high‐risk pregnancies. The second and the third sessions, based on the Health Belief Model, contained education regarding potential complications of pregnancy (including abortion, maternal death, fetal death, low birth weight, etc.), increasing the mother's perceived benefits regarding receiving prenatal care, as well as efforts to reduce barriers perceived by mothers for receiving prenatal care by highlighting the perceived benefits (to reduce the difficulty of obstacles to them). Additionally, to boost self‐efficacy, the (increasing maternal skills, using successful models, such as the experiences of other mothers who have successfully performed prenatal care in their first pregnancy in the same community with the same conditions, educational videos, setting schedules and verbal encouragement) participants in the intervention group received a training manual. Intervention adapted to local context: Not reported Women empowerment approach: Partial empowerment model Control (n = 75) Description: The control group received routine training at the care centers.
Outcomes	No outcomes of interest reported.
Notes	Funding: This study is a result of a health education and health promotion doctoral thesis approved by the health faculty of Tarbiat Modares University in Tehran. Hereby, we would like to thank the Tarbiat Modares University and Iranshahr Health Center and all the participants in this study.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Some concerns	No information allocation concealment but no baseline imbalance to suggest a problem.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Low risk	This trial was conducted in a single blind fashion in which the statistical analyst was not aware of the allocation of the women to the intervention or control groups, but the observers and participants were aware of their group assignment.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	Participants were probably aware of the intervention.
Missing outcome data	Low risk	All participants were included in the analysis.
Risk of bias in measurement of the outcome	Low risk	The outcome was measured using the standardized Health Belief Model constructs.
Risk of bias in selection of the reported result	Low risk	All the reported measures belong to the Health Belief Model.

PERMALINK

Effectiveness of nutrition counseling for pregnant women in low‐ and middle‐income countries to improve maternal and infant behavioral, nutritional, and health outcomes: A systematic review

Omar Dewidar

Jessica John

Aqeel Baqar

Mohamad Tarek Madani

Ammar Saad

Alison Riddle

Erika Ota

Jacqueline K Kung'u

Mandana Arabi

Manoj Kumar Raut

Seth S Klobodu

Sarah Rowe

Jennifer Hatchard

Jennifer Busch‐Hallen

Chowdhury Jalal

Sara Wuehler

Vivian Welch

Abstract

Background

Objectives

Search Methods

Selection Criteria

Data Collection and Analysis

Main Results

Authors’ Conclusions

1. PLAIN LANGUAGE SUMMARY

1.1. Nutrition counseling may improve some maternal and infant health and behavioral nutrition outcomes, but more high‐quality studies are needed

1.2. What is this review about?

1.3. What studies are included?

1.4. What are the main findings of this review?

1.5. What do the findings of this review mean?

1.6. How up‐to‐date is this review?

2. BACKGROUND

2.1. The problem, condition, or issue

2.2. The intervention

2.3. How the intervention might work

Figure 1.

2.3.1. Knowledge and awareness, outputs

2.3.2. Empowerment‐based counseling

2.3.3. Change in behavior

2.3.4. Long‐term outcomes

2.3.5. Contextual factors or mediating variables

2.4. Why it is important to do this review

3. OBJECTIVES

4. METHODS

4.1. Criteria for considering studies for this review

4.1.1. Types of studies

4.1.2. Types of participants

4.1.3. Types of interventions

4.1.4. Types of outcome measures

4.1.5. Impact of intervention on health equity

4.1.6. Other eligibility criteria

4.2. Search methods for identification of studies

4.2.1. Electronic searches

4.2.2. Searching other resources

4.3. Data collection and analysis

4.3.1. Description of methods used in primary research

4.3.2. Selection of studies

4.3.3. Data extraction and management

4.3.4. Assessment of risk of bias (ROB) in included studies

4.3.5. Measures of treatment effect

4.3.6. Unit of analysis issues

4.3.7. Criteria for determination of independent findings

4.3.8. Dealing with missing data

4.3.9. Assessment of heterogeneity

4.3.10. Assessment of reporting biases

4.3.11. Data synthesis

4.3.12. Subgroup analysis and investigation of heterogeneity

Empowerment approach classification

4.3.13. Sensitivity analysis

4.3.14. Summary of findings and assessment of the certainty of the evidence

5. RESULTS

5.1. Description of studies

5.1.1. Results of the search

Figure 2.

5.1.2. Included studies

Outcomes

Table 1.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Some concerns	There is no information about concealment of the allocation sequence and there were no differences between the study groups for demographic variables.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups as well as no information on adherence.
Missing outcome data	High risk	There is no information on the missingness.
Risk of bias in measurement of the outcome	High risk	There is no information who assessed the outcomes or details on the intervention to inform the possibility of the intervention being influenced by external factors.
Risk of bias in selection of the reported result	Some concerns	There is no information on the planned analysis of the authors and the framework used to develop the questionnaire.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Some concerns risk	No information on how the randomization was conducted. “Participants and data analysts were masked to group assignment.”
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Low	healthcare worker delivering the intervention was aware of the participants assigned to the trial however there were no deviations reported.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	Participants were possibly aware of their assigned intervention as well as the people delivering the intervention.
Missing outcome data	Low risk	Data was reported for most participants. Reason for missing participants was reported.
Risk of bias in measurement of the outcome	Some concerns	outcome measures were appropriate however assessors were not blinded.
Risk of bias in selection of the reported result	Low risk	All outcomes were measured as stated in methods

Methods	Cluster Randomized Controlled Trial of home visits in Florina, Greece
Participants	Inclusion criteria: women residing in the market towns and villages of Florina, Greece. Exclusion criteria: Not reported. Age [Mean (SD)]—Intervention, Control: 23.17 (0.31), 22.92 (0.31)
Interventions	Intervention—Nutrition intervention program (n = 300) Description: Nutrition education for the 300 women in the intervention group was provided through home visits every 2 week by the 10 nurses employed at the intervention group clinics, who had received intensive training for this purpose. Nutrition counseling messaging: basics of nutrition during pregnancy for the health of mother and fetus, including food sources and nation effects of selecting a balanced diet. The women were also taught practical techniques for improving the quality of their diets. They were encouraged to consume locally grown foods that have a high nutrient value and to prepare and preserve food in such a way as to reduce the loss of nutrients. Intervention adapted to local context: Not reported Women empowerment approach: Unclear empowerment approach. Control (n = 268) Description: Not described.
Outcomes	Hemoglobin, dietary intake, stillbirths, low birthweight, small for gestational Age (SGA)
Notes	Funding: Computer analysis of nutrient intake data was done by G Christakis and J Cassady of the Nutrition and Biostatistics Division, Department epidemiology, University of Miami School of Medicine. SN Pantelakis of the Agia Sophia Pediatric Hospital, Athens, and SA Doxiadis, Director of the Foundation for Research in Childhood, Athens, made substantive contributions in implementing the nutrition education program.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Some concerns	Centers were randomized but no explanation of the randomization process, no reporting of allocation conceallment. Baseline characteristics were balanced except for maternal weight, suggesting appropriate randomization.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	High risk	Because of the nature of the intervention, participants and personnel were made aware of their assignment during the trial, and no reporting of analysis to determine the effect of intervention assignment.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	High risk	There were difficulties experienced by the nurses and the program's coordinator in carrying out home visits during the winter months, when many of the county's mountainous villages are cut off by snow for days or weeks at a time, and no reporting of special analysis.
Missing outcome data	High risk	Incomplete sets of assessments were imbalanced across study arms, analysis therefore only focused on paired intergroup comparisons in dietary Intake at different points in time.
Risk of bias in measurement of the outcome	High risk	Nurses who delivered the intervention measured the outcomes. However, to minimize the possible bias associated with the nurses simultaneously delivering nutrition counseling and recording the effects in the intervention group (in terms of dietary histories and weight gain), the program's nurse coordinator periodically accompanied each nurse on their home visits to observe the data gathering and to sort out any associated problems.
Risk of bias in selection of the reported result	Low risk	data that produced this result was analyzed in accordance with a pre‐specified analysis plan that was finalized before unblinded outcome data were available for analysis.

Methods	Non‐randomized Controlled Study of four centers in the south and southeast of Karaj, Iran
Participants	Inclusion criteria: women with a prenatal care record, with a gestational age of 8–14 weeks, with a minimum literacy rate, who intended to live in Karaj during pregnancy, were included in the study from August to September 2011. Exclusion criteria: The person had a history of previously known illnesses such as cardiovascular, renal, respiratory, gastrointestinal, blood, autoimmune, diabetes, thyroid, epilepsy, chronic hypertension, and cancer. Abortion, multiple births, cerclage, preterm labor, pre‐eclampsia and a history of infertility, people using alcohol and drugs and antidepressants, and people on a diet specific to a chronic systemic disease, as well as people who are earlier than 6 weeks later. They were excluded from the study due to the termination of their pregnancy for any reason. Age [n (%)]—Intervention, Control: ‚≤19: 5 (12), 5 (12.2) 20–34: 32 (76), 33 (80.5) ≥35: 5 (12), 3 (7.3) Housewife [n (%)]—Intervention, Control: 40 (95.2), 38 (92.7) Education [n (%)]—Intervention, Control: Elementary and middle school: 13 (31), 17 (41.5) High school: 22 (52.5), 19 (46.3) University: 7 (16.5), 5 (12.2) Income less than 500 thousand tomans [n (%)]—Intervention, Control: 22 (52.5), 25 (61)
Interventions	Intervention—Nutrition intervention program (n = 44) Description: The sessions of each class were separate and at separate times. These classes were held in groups, with a minimum of 5 and a maximum of 11 people, in two sessions of approximately 60–90 min once a week for two consecutive weeks for each selected group of health centers. The presentation of an educational video as well as an educational booklet, which was given to mothers at the end of the first session, was used. Mothers were instructed to read the booklet within a week of the start of the second session. At the beginning of the second session, the researcher addressed the ambiguities of mothers. To answer the possible questions of the experimental group, a contact number was given to them. The content of the educational booklet is based on the basic information of scientific texts related to nutrition during pregnancy, including the book compiled by the Ministry of Health for health workers, and based on the initial assessment of the educational needs of pregnant women by asking open and closed questions. The pre‐intervention stage was developed. The general content of the training, after being prepared and approved by the professors of midwifery and nutrition, was prepared in a simple language and in a way that could be understood by the mothers. Nutrition counseling messaging: The content of nutrition education in the first session includes Familiarity with the main food groups and their recommended amounts in pregnancy and lactation, observing diversity and balance in the diet, improving eating habits and behavior, and explaining how the mother weighs in pregnancy, based on mass index It was the mother's body. To inform mothers about how to gain weight during pregnancy, the body mass index of each pregnant mother was calculated using height and weight before or early pregnancy and was marked in the relevant section of each person's educational booklet. The educational content of the second session included: how to take a variety of dietary supplements, vitamins and minerals during pregnancy and lactation, familiarity with common problems during pregnancy and advice on how to deal with them, as well as nutritional tips for dealing with complications and diseases during pregnancy. The final 30 min in each session were devoted to questions and answers. Intervention adapted to local context: Not reported Women empowerment approach: Unclear empowerment approach. Control (n = 44) Description: The control group received another training with completely different content and did not affect the outcome of this study, with approximately the same number of sessions and duration, which by asking Experts in this field, the control group received training in almost the same way in the field of sexual health.
Outcomes	No outcomes of interest reported.
Notes	Funding: This article has been extracted from a student dissertation, the design of which has been approved by Tabriz University of Medical Sciences with the number 9014 on 2/14/2011. Due to the assistance and cooperation of the Vice Chancellor for Research and the Faculty of Nursing and Midwifery of Tabriz University of Medical Sciences due to the financial and spiritual support of this project, the cooperation of Karaj University of Medical Sciences and Alborz health centers in collecting data.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	High risk	There is no information about randomization process and there are baseline imbalances
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups as well as no information on adherence.
Missing outcome data	High risk	There is no information on the missingness or follow up of participants from eligibility to analysis
Risk of bias in measurement of the outcome	High risk	There is no information who assessed the outcomes or details on the intervention to inform the possibility of the intervention being influenced by external factors.
Risk of bias in selection of the reported result	Some concerns	There is no information on the planned analysis of the authors and the framework used to develop the questionnaire

Methods	Cluster Randomized Controlled Trial, Namkumba area in Mangochi, one of the 12 districts in the southern region of Malawi.
Participants	Inclusion criteria: All consenting pregnant women who were between their 9th and 16th gestational week, both primi‐ and multiparous, were eligible for inclusion. Exclusion criteria: Women carrying multiple fetuses and those with severe illnesses were excluded from the study. Age [Median (IQR)]: ‐ Intervention, Control: 24 (19–30), 23 (18–28) Geographic location [n (%)]: ‐ Intervention, Control: Lakeshore: 43 (46.7), 60 (58.3) Upland: 49 (53.3), 43 (41.7) Household head gender [n (%)]: ‐ Intervention, Control: Female: 7 (4.3), 9 (11.7) Male: 85 (95.7), 94 (88.3) Education [n (%)]: ‐ Intervention, Control: Illiterate/primary: 79 (83.7), 79(78.6) Secondary/above: 13 (16.3), 24(21.4) Socioeconomic status [n (%)]: ‐ Intervention, Control: Very‐poor: 31 (33.7), 29 (28.2) Poor: 39 (42.4), 43 (41.7) Well‐off: 22 (23.9), 31 (30.1) Marital status [n (%)]: ‐ Intervention, Control: Single: 9 (4.3), 12 (16.5) Married: 83 (95.7), 91 (83.5),
Interventions	Intervention—Nutrition education (n = 121) Description: Nutrition education for the 300 women in the intervention group was provided through home visits every 2 weeks by the 10 nurses employed at the intervention group clinics, who had received intensive training for this purpose. Nutrition counseling messaging: Basics of nutrition during pregnancy for the health of mother and fetus, including food sources and nation effects of selecting a balanced diet. The women were also taught practical techniques for improving the quality of their diets. They were encouraged to consume locally grown foods that have a high nutrient value and to prepare and preserve food in such a way as to reduce the loss of nutrients. Intervention adapted to local context: Not reported Women empowerment approach: Partial empowerment model Control (n = 136) Description: Not described
Outcomes	No outcomes of interest reported.
Notes	Funding: This project was funded by the University of Oslo, The Global Health and Vaccination Program (GLOBVAC) of the Research Council of Norway and by the Throne Holst Foundation.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Low risk	The villages were assigned STATA generated random numbers to allocate them to either the intervention or the control group, generating 10 clusters in each study group. The women from these clusters were identified by the study team in their communities and referred to the nearest designated local health center where their pregnancy and the gestational age were confirmed and where they were also invited to consent to participate in the study.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	High risk	There is no information on whether the participants and carers were aware of the intervention groups as well as no information on adherence.
Missing outcome data	High risk	There is no information on the missingness or follow up of participants from eligibility to analysis
Risk of bias in measurement of the outcome	High risk	There is no information who assessed the outcomes or details on the intervention to inform the possibility of the intervention being influenced by external factors.
Risk of bias in selection of the reported result	Some concerns	There is no information on the planned analysis of the authors and the framework used to develop the questionnaire

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	Low risk	Randomization was performed using computer‐generated randomization schedules.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	No information on blinding, no information on deviations that arose.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Some concerns	No information on blinding of participants or deviations that arose.
Missing outcome data	Some concerns	Almost all the participants were analyzed.
Risk of bias in measurement of the outcome	Low risk	outcome measurement was appropriate and similar across groups. No information on outcome assessor's awareness of intervention but highly unlikely to influence measurement.
Risk of bias in selection of the reported result	Low risk	All outcomes reported appropriately.

Bias	Author's judgment	Support for judgment
Risk of bias arising from the randomization process	High risk	Allocation concealment was not mentioned and there was a significant difference across education level (p = 0.001*) and household income across groups.
Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)	Some concerns	participants were likely to be aware of the intervention as mothers who met the inclusion criteria were placed either in the intervention or comparison group according to their respective villages and were recruited on a rolling basis. However, there were no deviations from the trial context and appropriate analysis was conducted.
Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)	Low risk	Participants could have possibly been aware of assigned intervention due to allocation method however there were no failures in implementing the intervention.
Missing outcome data	Some concerns	Data was missing for 105 participants which may have contributed to the baseline imbalance.
Risk of bias in measurement of the outcome	Low risk	Outcome measures were appropriate and assessors were independent for groups. there was probably no differnece in how the outcome was measured across groups.
Risk of bias in selection of the reported result	Low risk	All outcomes reported approprriety