Table 1.

Completed and other ongoing randomized, controlled trials aiming to prevent obesity through during infancy

Name/trial registry number	Framework	Sample size	Intervention(s)	Outcome(s)
Completed trials
Educational intervention to modify bottle-feeding behaviors [73]	Experiential Learning Cycle for Adult Learning	40	- Group intervention for Women, Infants, and Children (WIC) participating mothers of 1–2 month old formula-fed infants	- No difference in daily formula intake at 4–5 months
			- Increase awareness of satiety cues	- Intervention group had greater weight gain than control between time of intervention and follow-up at infant age 4–5 months
			- Limit bottle size to 6 ounces or less in first 4 months
First steps for mommy and Me [74]	Motivational Interviewing	84	- Primary care provider “negotiations” at well child care to endorse behavior change	- Later introduction of solids
			- Health educator calls between visits to discuss maternal healthy lifestyle plus infant obesity preventive guidance	- Modestly less TV viewing
			- Printed Materials	- Larger increases in nocturnal sleep duration from baseline to follow-up and improvements in sleep hygeine
			- Monthly group parent training sessions	- No significant difference in weight-for-length z-score
SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Study [71]	Responsive Parenting	160	- 2×2 design using home nurse visits among mothers intending to breastfeed	- “Soothe/Sleep” breastfeeding infants slept more, had fewer noctural and total daytime feeds
			- “Soothe/Sleep” - discriminate hunger vs. other distress, educate on soothing strategies, day/night differences	- “Introduction of Solids” infants – later intro & were more likely to accept novel healthy foods at age 1 year
			- “Introduction of Solids” - delay introduction, hunger/satiety cues education (2–3 weeks), repeated exposure to vegetables (~4-6 months)	- Infants receiving both interventions had a significantly lower weight-for-length z-score at age 1 year
Healthy Beginnings Trial [75,76]	Health Beliefs	667	- Intensive home nurse visitation over first 2 years plus phone support vs. usual care among socially high-risk families	- At age 2 years, BMI significantly lower for intervention group vs. control
			- Key messages: “Breast is best”, “No solids for me until 6 months”, “I eat a variety of fruit and vegetables every day”, “Only water in my cup”, “I am part of an active family”	- Intervention group ate more vegetables, less meals with TV, and more physical activity
NOURISH Trial [77-79]	Cognitive Behavioral with Anticipatory Guidance	698	- Two modules of group parent education and peer support sessions held co-led by dietician and psychologist timed around a) introduction of solids and b) emergence of autonomy and independence	- Lower BMI-for-age Z-score and less rapid infant weight gain since birth at 13–14 months
			- Parents instructed to overcome neophobia and increase healthy food acceptance through teaching on healthy infant growth and requirements, variability of intake within/between infants, amount/timing of snacks, hunger/satiety cues	- No difference with control group for BMI at age 2 years
			- Parents instructed to help develop infant self-regulation and healthy diet with lessons on managing food refusal/neophobia/fussing, developmental need for autonomy and limit testing, modeling healthy food choices	- Mothers used more responsive feeding practices
				- Mothers less likely to use food as a reward or turn meals into a game
MOMS Project [80,81]	Anticipatory Guidance	292	- Primary care anticipatory guidance-based study comparing 3 interventions delivered at well child care by primary care providers plus handouts: Mother focused (maternal eating habits and modeling eating) vs. Infant focused (serving size, introduction of solids, feeding style) vs. usual care	- No difference in growth parameters between groups at 1 year
				- Mothers in mother and infant focused groups gave less juice and gave more fruit and vegetables than those in the usual care group.
The Infant Feeding Activity and Nutrition Trial (INFANT) [82-84]	Parent support theory; Social cognitive theory	542	- Community-based existing maternal-child health nurse-led groups with dietician led intervention (6 – two hour sessions delivered quarterly) vs. control (usual care)	- At age 20 months there was no difference in BMI between groups, but intervention group showed a modest reduction in sweet snack intake and a modest reduction in TV viewing
			- Developmentally appropriate guidance on parent feeding style, timing of introduction of solids, nutrition, parent modeling, managing food rejection	- No group differences in fruit/veggie/water/sweetened beverage intake, physical activity
Trials with Published Methods				Primary Outcome
Mi Voglio Bene [85]	Anticipatory Guidance	3610	- Primary care based delivery of 10 preventive actions (promotion of breastfeeding, delayed introduction of solids, control of protein intake in first 2 years, avoidance of sweetened beverages, avoidance of bottle use after 2 years, promoting physical activity, identification of early adiposity rebound, limit TV viewing, encouraging play, controlling portion size	- BMI at age 6 years
Prevention of Overweight in Infancy (POI.nz) [86]	Anticipatory Guidance	800	- 4 arm trial comparing usual care with usual care plus either a Food, Activity, and Breastfeeding intervention or a Sleep intervention or both interventions delivered in well care supplemented by research nurses, lactation consultants and/or sleep specialists	- BMI at age 2 years
Healthy Babies [87]	Theory of Planned Behavior	372	- Paraprofessional home visits providing guidance on normative growth and development and skill-building on maternal feeding and feeding responsiveness,	- Weight-for-length at age 1 year
Preventing Childhood Obesity through Early Feeding and Parenting Guidance [88]	Personalized Anticipatory Guidance	140	- Community health worker home visits with focus on preventing obesogenic feeding behaviors, parental recognition of cues, play without screen time, and good sleep hygiene	- Weight-for-length at ages 1 and 2 years
Greenlight Study [89]	Social Cognitive Theory	865	- Low literacy materials delivered during well child visits by pediatric residents focusing on satiety cues, sweetened beverages, introduction of solids, portion sizes, non-sedentary activity, and breastfeeding	- BMI at 2 years