Abstract
Objective
To assess the efficacy of a home-based lifestyle intervention delivered through Parents as Teachers (PAT), a national home visiting organization, designed to minimize excessive weight gain through 12-months postpartum in socioeconomically disadvantaged (SED) African American women with overweight or obesity.
Methods
This randomized controlled trial was conducted at a single center as part of the LIFE-Moms consortium. Analysis was conducted with 185 SED African American women (BMI 25.0–45.0 kg/m2 at pregnancy onset), retained from an original sample of 267 randomized to standard PAT or PAT+Lifestyle, which embedded lifestyle therapy within standard PAT delivered prenatally and for 12-months postpartum.
Results
Compared with standard PAT, the PAT+Lifestyle group gained less weight (2.5 kg vs. 5.7 kg, P=0.01) and were more likely to return to their baseline weight (38.0% vs. 21.5% P=0.01) from baseline to 12-months postpartum. There were no differences between groups in cardiometabolic outcomes, indices of glycemic control and insulin sensitivity, and plasma lipid profile. The estimated cost of PAT+Lifestyle was $81 more to deliver per family than standard PAT.
Conclusions
PAT+Lifestyle decreases weight gain during pregnancy through 12-months postpartum in SED African American women with overweight or obesity at the start of pregnancy with minimal additional cost.
Keywords: Obesity, Postpartum weight, African American women, Home-based lifestyle therapy
Introduction
The prevalence of overweight and obesity is high among African American women, particularly those who are underserved and socioeconomically disadvantaged (SED) (1–4). Women with obesity are at increased risk of excessive gestational weight gain (GWG) during pregnancy and have greater weight retention one year after delivery, thereby increasing the severity of their obesity and the risk of obesity-related medical co-morbidities (4–6). Although lifestyle intervention is recommended for pregnant women with obesity to prevent excessive GWG and postpartum weight retention (7), providing effective real-world therapy in SED women is difficult because of the many barriers to program participation related to parenting responsibilities, costs, limited transportation, and other stressors (8–10).
Partnerships with organizations trusted by women in the community offer an infrastructure for overcoming challenges associated with reaching young mothers, particularly those who are SED (8, 11–14). Parents As Teachers (PAT) is a national home visiting organization whose mission is to empower parents as their child’s most influential teacher. PAT trains parent educators to deliver an evidence-based curriculum through home visits. PAT visits are generally reimbursed via federal (e.g. Maternal Infant, and Early Childhood Home Visiting Program) and/or state programs (e.g. State Department of Elementary or Secondary Education). PAT visits are provided free of charge to any high needs parents as defined by: low educational attainment, low income, parent or child with disabilities/chronic health condition, recent immigrant family, parent with mental illness, or unstable housing (15). In 2016–17 PAT was located in all 50 states and reached nearly 190,000 families, 227,000 children, and 20,100 pregnant women (16).
We previously found that working with PAT provided an effective approach for implementing dietary interventions targeted to African American parents of infants (17), rural parents of young children (18), teen mothers (9), and overweight mothers at risk for diabetes (19). In addition, we recently completed a randomized controlled trial to determine whether partnering with PAT to provide a home-based lifestyle intervention could overcome barriers to behavior change and decrease GWG in this high-risk population (20). Our data demonstrated that, compared with standard PAT, embedding a lifestyle intervention focused on eating and physical activity behavior change strategies within the PAT prenatal program (PAT+Lifestyle) decreased GWG and lowered maternal systolic blood pressure. However, there was no difference in other maternal cardiometabolic outcomes, pregnancy complications, or neonatal outcomes. The effect of continuing this intervention on postpartum weight and metabolic health is not known.
The primary purpose of the present randomized controlled trial was to determine the efficacy of PAT+Lifestyle, provided both prenatally and postpartum, in minimizing the long-term, 12-month postpartum increase in body weight that often occurs in SED African American women who are overweight or obese at the onset of pregnancy. In addition, we assessed obesity-related cardiometabolic outcomes (i.e. blood pressure, insulin sensitivity and lipid profile) at 12-months postpartum as well as the cost of providing the PAT+Lifestyle intervention. We hypothesized that compared with women randomized to standard PAT, those randomized to PAT+Lifestyle would have a blunted increase in body weight at 12-months postpartum and a healthier cardiometabolic profile, at minimal additional cost.
Methods
Study participants
The study population was comprised of 267 women who were recruited from the obstetrical clinics at a single medical center (Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, MO) between October 2012 and March 2016. All participants identified as African American and met the following additional eligibility criteria: 1) age 18–45 years; 2) body mass index (BMI) 25.0–45.0 kg/m2 measured at the initial visit during the first trimester; 3) singleton viable gestation at or before 15 0/7 weeks (established by date of last menstrual period if it was within 5 days of first trimester ultrasound dating, or by ultrasound itself); and 4) SED determined by Medicaid status, or home zip code associated with a median household income below the poverty level. All women provided written informed consent before their participation in this study, which was approved by the Institutional Review Board of Washington University in St. Louis, MO (ClinicalTrials.gov: NCT01768793).
Procedures
This study was conducted at one site of the LIFE-Moms consortium, a collaborative group evaluating the effect of lifestyle therapies on maternal GWG and maternal, fetal and infant health in pregnant women with overweight or obesity (21). Women were randomly assigned by study staff in a 1:1 allocation to treatment with either standard PAT or PAT+Lifestyle, which began after the baseline assessment and continued until 12-months after parturition. A random number generator and a fixed allocation block strategy provided by study statisticians were used to determine the randomization sequence. Investigators and clinical research staff who were involved in collecting primary and secondary outcome data, did not deliver the intervention and were blinded to group assignment. The results from the prenatal intervention (baseline to 35 weeks) were previously reported (20). Data were obtained at 15 weeks of gestation (baseline) and 12-months postpartum by research staff at the Washington University Clinical and Translational Research Unit. Body weight, plasma glucose, insulin and lipid concentrations, were collected as well as the plasma glucose and insulin response to an oral glucose load (blood samples obtained before and at 30, 60, 90, and 120 minutes after ingesting a 75-g glucose drink).
Intervention staff, consisting of parent educators overseen by a study interventionist, were responsible for conducting all aspects of either the standard PAT or PAT+Lifestyle intervention. Intervention staff were not involved in primary or secondary data collection. To assure intervention fidelity, parent educators audio-recorded each of their home visits and completed lesson plan checklists documenting delivery of content. The study interventionist randomly observed four home visits and reviewed four audio-recorded visits each year for each parent educator, to assure satisfactory completion of content. The additional per-family cost of providing the PAT+Lifestyle intervention to standard PAT was calculated using PAT recommended cost and budgeting guidelines (15) which includes parent educator salary, training costs, home visit preparation and contact time, travel reimbursement based on car mileage, and cost of supplies per visit.
All participants were seen by parent educators during home visits, every other week during pregnancy, and every month for 12-months postpartum. The standard PAT curriculum provided parents with evidence-based maternal, infant and early childhood information designed to increase parenting knowledge and skills using a family strength-based model to support the role of the parent as their child’s first and best teacher (22). Parent educators delivering the standard PAT prenatal curriculum prepared the mother for what to expect with a new baby by providing developmentally appropriate child-focused information; the curriculum does not include information on maternal weight or lifestyle change. After childbirth, the parent educator offered social support for parents in meeting the physical, emotional, and psychological milestones as children transition across developmental stages (22).
The PAT+Lifestyle postpartum curriculum goal was for mothers to return to their baseline weight by reinforcing the eating and activity behaviors learned prenatally, while also addressing challenges faced by the new parent of an infant (e.g. child feeding, sleep deprivation), as described in detail elsewhere (20). The PAT+Lifestyle curriculum embedded content adapted from the Diabetes Prevention Program within the standard PAT curriculum and home visits (23). An evaluation of the mother by the PAT parent educator was used to individualize the lifestyle content to address specific eating and physical activity behaviors that affect energy intake and physical activity (e.g. substitute water for sugar-sweetened beverages, reduce portion sizes, walk 30 minutes every day). Social Cognitive Theory was used to promote behavior change emphasizing parenting roles, and targeting intrapersonal (e.g. self-assessment, goal setting, reinforcement), interpersonal (e.g. observational learning/parental modeling), and home environment (e.g. child exposure to media/TV, food access) strategies (24). In addition to training on the standard curriculum, PAT+Lifestyle parent educators received 8 hours of additional training including: 1) an overview of the intervention protocol; 2) home visit practice sessions with other parent educators; and 3) feedback from trainers. Because the PAT+Lifestyle intervention was embedded within the standard curriculum it was reimbursable as part of routinely delivered home visits.
The primary outcome of this study was percent change in body weight from baseline to 12-months postpartum. Secondary outcomes were: 1) proportion of women returning to baseline weight at 12-months postpartum, and 2) proportion of women with GWG (total weight gain from the baseline visit to 35–36 weeks gestation visit) categorized as above or not above Institute of Medicine weight gain during pregnancy guidelines (25).
Statistical Analysis
A modified intention-to-treat analysis was performed. All subjects were analyzed within the group to which they were randomized unless they provided no follow-up data or could not provide valid data due to a second pregnancy. Baseline demographic factors and characteristics of each treatment group were compared using the Student’s t-test or Mann Whitney U test (continuous variables) or the χ2 or Fisher’s exact test (categorical variables), as appropriate. Normality was tested with the Kolmogorov-Smirnov test. To test the primary hypothesis, an Analysis of Covariance (ANCOVA) was performed to determine whether there was a significant difference in weight change and metabolic measures between baseline and 12-month postpartum visit by intervention group. Block randomization was used to balance the treatment groups on maternal age, BMI at randomization, baseline weight (weight at randomization), gestational age at randomization, Medicaid status, education, income, gravidity, nulliparity, gestational diabetes, infant birthweight, and breastfeeding initiation. We tested for confounding factors to further evaluate whether any unexpected imbalances between groups could have affected our results. BMI and gestational age at randomization were chosen a priori as confounders in the final models. The proportion of women with a 12-month postpartum weight that returned to or below baseline weight was compared by intervention group using the χ2 or Fisher’s exact test as appropriate, and log binomial regression was used to compute relative risks and 95% confidence intervals. Women with missing data on pre-specified factors were excluded from analysis as per study protocol; missing data were assumed to be missing at random. A sensitivity analysis was conducted to compare women who completed and did not complete the 12-month postpartum visit on maternal age, BMI, weight, and gestational age at baseline, Medicaid status, education, income, gravidity, nulliparity, gestational diabetes, infant birthweight, and breastfeeding initiation. A P-value of <0.05 was considered statistically significant. SAS version 9.4 (SAS Institute Inc., Cary, NC) was used for all analyses.
Power computations were based on the primary endpoint of percent of subjects meeting IOM guidelines for GWG, and on two-sided tests at the 0.05 level of significance, as described previously (20). We estimated that 57% of standard PAT participants would meet IOM recommendations for GWG and that 120 participants who completed the intervention in each group would yield a power of 0.8 to detect a 30% increase to 74% in the PAT+Lifestyle group and a power of 0.9 to detect a 35% increase to 77%. We expected a 10% dropout rate prior to parturition, and successfully sought to randomize 133 participants into each group. Based on the assumption that 100 participants would remain at 12 months postpartum, the power was 0.8 and 0.9 or 93% and 95%, respectively.
Results
Participant demographics and flow
The flow of participants throughout the study is shown in Figure 1. Baseline characteristics of the study participants were not different between groups (Table 1). The mean and standard deviation for gestational age at the prenatal visit used to define BMI is 13.3±1.6 weeks. Among the 267 randomized participants, 185 completed the 12-month postpartum visit. The major reasons for non-completion were women who were withdrawn because of a new pregnancy (8.9%) and women who could not be located (17.9%). Excluding participants who were ineligible due to new pregnancy, the retention rate for the 12-month visit was 76.1%. No significant differences in baseline characteristics were observed between women who completed vs. did not complete the 12-month postpartum visit in the sensitivity analysis (data not shown).
Figure 1.
Flow of study participants
Table 1.
Baseline Characteristics of Standard PAT and PAT+Lifestyle Groups
| Standard PAT (N=93) | PAT+Lifestyle (N=92) | P value | |
|---|---|---|---|
| Maternal age (yrs) a | 26.16 ± 5.0 | 24.74 ± 5.0 | 0.06 |
| Gestational age at randomization (wks) | 14 (12,15) | 14 (12,15) | 0.99 |
| Baseline weight (kg) a | 86.43 ± 15.0 | 87.24 ± 15.8 | 0.72 |
| Baseline BMI (kg/m2) b | 31.93 ± 5.0 | 32.73 ± 5.2 | 0.29 |
| BMI Category c | 0.68 | ||
| Overweight | 34 (35.6) | 31 (33.7) | |
| Obese | 59 (63.4) | 61 (66.3) | |
| On Medicaid c | 84 (90.3) | 83 (90.2) | 0.98 |
| Maternal education c | 0.46 | ||
| Less than high school | 15 (16.1) | 17 (18.5) | |
| High school graduate | 36 (38.7) | 44 (47.8) | |
| Some college | 33 (35.4) | 24 (26.1) | |
| College graduate | 9 (9.7) | 7 (7.6) | |
| Income level c | 0.62 | ||
| <$25,000 | 84 (90.3) | 85 (92.4) | |
| ≥$25,000 | 9 (9.7) | 7 (7.6) | |
| Gravidity b | 2 (1, 3) | 2 (1, 3) | 0.17 |
| Nulliparous | 17 (18.3) | 23 (25.0) | 0.27 |
| Gestational diabetes c | 9 (9.7) | 10 (10.9) | 0.79 |
| Infant birth weight (g) a | 3132.7 ± 442.9 | 3106.4 ± 442.8 | 0.71 |
| Initiated some breastfeeding c | 61 (65.6) | 65 (70.7) | 0.46 |
| Weeks of Breastfeeding b | 8 (4, 24) | 15 (5, 24) | 0.25 |
BMI, body mass index
Data are means ± SD, p-value based on t-test
Data are median (IQR), p-value based on Mann Whitney U test
Data are n (%), p-value based on χ2 or Fisher’s exact test
Body weight
The increase in body weight from baseline to 12-months postpartum, after adjusting for BMI and gestational age at randomization, was less in the PAT+Lifestyle group than in the standard PAT group (2.5 ± 7.4 kg vs. 5.7 ± 8.8 kg, P=0.01) (Figure 2). In women who did not exceed the IOM guidelines for GWG, those treated with PAT+Lifestyle retained less weight at 12-months after delivery than those treated with standard PAT (0.9± 6.8 kg and 4.2± 8.6 kg, p=0.03), after adjusting for BMI and gestational age at randomization. In women who exceeded the IOM guidelines for GWG, those treated with PAT+Lifestyle tended to retain less weight at 12-months postpartum than those treated with standard PAT. However, the differences between groups were not statistically significant (4.9 ±7.7 kg and 7.6 ± 8.9 kg, p=0.19). A greater percentage of women in the PAT+Lifestyle group than in the standard PAT group returned to their baseline weight or less at 12-months postpartum (38.0% and 21.5% in PAT+Lifestyle and standard PAT groups, respectively, P=0.01); the difference between groups remained statistically significant after adjusting for BMI and gestational age at randomization (adjusted relative risk 2.24, 95%CI 1.17–4.29).
Figure 2.
Percent (top panel) and absolute (bottom panel) change in body weight from baseline to 12 months postpartum in women treated with standard PAT (white bars) or PAT+Lifestyle (black bars) in total participants and in subgroups in whom gestational weight gain (GWG) was either not greater than, or was greater than, Institute of Medicine (IOM) guidelines.
* Value significantly different from corresponding standard PAT value, P ≤0.03. Values are means ± SEM.
Cardiometabolic outcomes
No significant differences in changes in blood pressure, indices of glycemic control and insulin sensitivity, or plasma lipid profile, from baseline to 12-months postpartum, were detected between PAT+Lifestyle and standard PAT groups (Table 2).
Table 2.
Cardiometabolic Variables at baseline and 12-months postpartum in Standard PAT and PAT+Lifestyle Groups
| Standard PAT (n=93) | PAT+Lifestyle (n=92) | ||||
|---|---|---|---|---|---|
| Baseline | 12-months Postpartum | Baseline | 12-months Postpartum | p-value a | |
| SBP (mmHg) | 110.9 ± 10.9 | 118.6 ± 12.8 | 119.1 ± 10.4 | 115.1 ± 10.7 | 0.80 |
| DBP (mmHg) | 67.3 ± 8.3 | 71.7 ± 10.1 | 67.2 ± 8.8 | 72.4 ± 10.7 | 0.63 |
| Glucose (mg/dL) | 81.0 ± 6.2 | 88.2 ± 7.8 | 89.4 ± 7.6 | 89.4 ± 7.5 | 0.34 |
| Insulin (uU/mL) | 11.8 ± 7.6 | 15.0 ± 9.6 | 13.4 ± 7.7 | 17.2 ± 10.4 | 0.41 |
| HOMA-IR | 2.41 ± 1.7 | 3.29 ± 2.3 | 2.76 ± 1.8 | 3.88 ± 2.6 | 0.33 |
| Glucose AUC (mg/dL x 120 min) | 15341 ± 2134 | 15817 ± 2043 | 15179 ± 1747 | 16021 ± 2235 | 0.26 |
| Insulin AUC (uU/dL x 120 min) | 13787 ± 8669 | 13048.2 ± 8249 | 14744 ± 7622 | 13417 ± 7779 | 0.85 |
| OGIS | 399 ± 69 | 376 ± 66 | 391 ± 68 | 367 ± 64 | 0.56 |
| Cholesterol (mg/dL) | 161.0 ± 31.9 | 144.6 ± 29.6 | 161.1 ± 30.9 | 146.0 ± 27.2 | 0.68 |
| LDL-cholesterol (mg/dL) | 81.5 ± 25.0 | 85.9 ± 24.1 | 83.6 ± 25.4 | 88.0 ± 24.1 | 0.84 |
| Triglycerides (mg/dL) | 84.0 ± 37.5 | 62.0 ± 34.7 | 81.9± 26.8 | 62.3 ± 29.9 | 0.85 |
| HDL-cholesterol (mg/dL) | 62.6 ± 13.9 | 46.3 ± 11.8 | 61.1 ± 11.2 | 46.2 ± 11.0 | 0.56 |
Data are means ± SD
SBP: Systolic Blood Pressure; DBP: Diastolic Blood Pressure; LDL: Low-density-lipoprotein Cholesterol; HDL: High-density-Lipoprotein Cholesterol; HOMA-IR: Homeostatic Model Assessment for Insulin Resistance; AUC: Area under the Curve; OGIS: Oral Glucose Insulin Sensitivity
Significance of difference between intervention groups in the change in measures obtained at baseline and 12-month postpartum, p-value based on ANCOVA
Compliance with visits and cost of intervention
The median number of total prenatal and postpartum home visits were not different between women treated with PAT+Lifestyle and those treated with standard PAT [17 (12, 21) and 16 (13, 20) visits, respectively, P = 0.72]. The postpartum visits accounted for 48.5% of the total number of visits, and the median number of postpartum visits were not different between groups [9 (5, 12) and 8 (4, 12) visits for PAT+Lifestyle and standard PAT, respectively (P = 0.56)]. The average duration of each visit was longer in the PAT+Lifestyle than the standard PAT group (49.8 ±10.3 min and 38.2 ±13.0 min, P < 0.01). Overall, the fidelity to the intervention was 75% (75%−100%).
The cost to implement standard PAT was calculated based on standard parent educator training costs of $1,400 with a yearly professional development cost of $450; average parent educator salary for 2 hours of preparation time plus the cost of a 1-hour home visit ($54.69); mileage estimate per visit ($10.80); and supplies per visit ($5.00). Costs for the PAT+Lifestyle intervention included the standard intervention costs plus the costs for the additional 8 hours of training ($450 per parent educator). Even though the duration of the home visits were longer in the PAT+Lifestyle intervention, they did not exceed the 60 minutes allotted for completing a home visit, and upon which costs for reimbursement were calculated. Therefore, the total cost per family to implement standard PAT and PAT+Lifestyle from early pregnancy until 12-months postpartum was $1,160.65 and $1,241.68. respectively; the additional cost per family for providing PAT+Lifestyle was $81.03. The addition of lifestyle therapy to standard PAT was covered as part of routine home visits and did not result in any charges to the family.
Discussion
This randomized controlled trial was conducted to evaluate whether a home-based parent education program (PAT+Lifestyle) delivered both prenatally and postpartum, could limit weight gain from early pregnancy (~15 weeks gestation) to 12-months postpartum in underserved, SED African American women with overweight or obesity at the onset of pregnancy. Our data demonstrate that women who recieved PAT+Lifestyle gained less weight and were more likely to return to their baseline weight at 12-months after parturition than women treated with the standard PAT program. In addition, the cost of providing PAT+Lifestyle during pregnancy and for 12-months postpartum was only about $81 more than providing standard PAT. This home-based lifestyle intervention program successfully reduced weight gained during pregnancy and retained during the postpartum period in a vulnerable, high-risk population. Moreover, providing this therapy in partnership with an established national home visiting program allows for widespread dissemination at minimal additional cost.
The results from several randomized controlled trials have shown that providing lifestyle therapy only during pregnancy or the postpartum period did not decrease the amount of weight gained from the onset of pregnancy to 12-months postpartum (4, 26–31). We are aware of one study, the Delta Healthy Sprouts Trial, that used PAT to provide home-based lifestyle weight management during pregnancy and 12-months postpartum (10, 32). That trial, conducted in women living in the rural Lower Mississippi Delta region, did not detect a significant difference in postpartum weight loss or retention between women treated with PAT lifestyle enhanced intervention and those treated with PAT alone. The reasons for the different outcomes in the Delta Healthy Sprouts Trial and our study are not clear, but may be related to differences in study populations and the lifestyle curriculum. Nearly half of the participants in the Delta Healthy Sprouts Trial were normal-weight before pregnancy, and that trial enrolled fewer participants than in our study, which may have decreased the ability to detect differences between treatment groups. The lifestyle curriculum in the Delta Healthy Sprouts Trial also involved a complex intervention, including personalized eating plans that targeted energy restriction, diet quality, and multiple behaviors simultaneously. In contrast, PAT+Lifestyle focused on a limited number of specific and simple eating and activity behaviors, individualized to the family’s needs, and embedded within standard parent-child activities and content of routine home visits, requiring limited additional time (20).
Despite the beneficial effects of PAT+Lifestyle on postpartum body weight, there were no therapeutic effects on cardiometabolic outcomes. However, the health benefits of minimizing total weight gain that occurs from the onset of pregnancy to 12-months postpartum in women with overweight or obesity are likely to occur years later by reducing or preventing the medical complications associated with weight retention after pregnancy and a chronic increase in body fat (33). Data from previous studies have shown GWG and postpartum weight retention at 12-months are associated with changes in weight status and the development of obesity-related comorbidities decades after pregnancy (34, 35). Early adulthood (18–35 years of age) is a vulnerable period for excessive weight gain and the development of obesity, particularly among African American women and those who are already overweight (33, 34, 36, 37). A 5-kg weight gain during early adulthood, which is less than the average weight gained in women treated with standard PAT in our study, is associated with an increased risk of serious diseases, including type 2 diabetes, cardiovascular disease, and cancer, by middle and later adulthood (33). Minimizing total prenatal and postpartum weight gain in SED African American women by treatment with PAT+Lifestyle has considerable clinical implications by preventing future obesity-related medical comorbidities.
Implementing effective lifestyle change in pregnant or postpartum SED women is difficult because of the many burdens that interfere with participation or intervention uptake, including limited finances, work responsibilities, and childcare support (38). The use of PAT to provide lifestyle weight management therapy takes advantage of a home visiting structure that is free-of-charge, already accepted by the mother, and overcomes many of the major barriers for implementing successful lifestyle therapy in SED African American women (23, 39, 40). Additionally, PAT services are delivered until the last child in the home reaches school age, allowing for ongoing reinforcement of lifestyle behavior change. The additional cost of PAT+Lifestyle for the entire prenatal and 12-month postpartum intervention was minimal. Because the content is delivered as part of the standard PAT routine visit, it is covered by federal and state funds, providing ongoing support for implementation.
This study has several limitations. The generalizability of our results may be limited because participants were from a single racial/ethnic group and were from homogeneous sociodemographic and geographic backgrounds, which may not translate to other populations. In addition we only evaluated women at 12 months postpartum so we are unable to determine if results will be maintained long-term and to inform patterns of weight gain or loss over time.
In conclusion, the present study demonstrates that providing a home-based lifestyle weight management therapy effectively minimizes maternal weight gain at 12-months postpartum in underserved, SED African American women with obesity at the onset of pregnancy. Embedding PAT+Lifestyle within the national infrastructure of PAT overcomes many of the barriers faced by SED women that prevent active participation in this kind of intervention. Moreover PAT, which has more than 3,200 sites across the United States, provides a sustainable and scalable program for providing an effective weight management intervention for this high-risk population. Based on these findings the PAT National Center, which is responsible for training and certifying all parent educators to deliver PAT curricula, is planning to disseminate and implement PAT+Lifestyle through their national network of sites. Additional research will be needed to determine whether extending PAT+Lifestyle throughout the entire PAT program has important long-term maternal weight and health benefits.
Study Importance Questions.
What is already known about this subject
Prevalence of overweight and obesity are high among pregnant women who are socioeconomically disadvantaged (SED) and among African American women.
African American women are likely to retain twice as much weight postpartum as are Caucasian women.
Weight gain during pregnancy and postpartum are important causes of long-term weight gain in women and the development of obesity-related comorbidities decades after pregnancy.
What this study adds
Home-based lifestyle therapy delivered through Parents as Teachers (PAT) decreases 12-month postpartum weight gain in SED African American women with overweight or obesity.
A lifestyle intervention embedded within PAT, a national home visiting organization, provides a sustainable, scalable, and effective national weight management intervention for SED African American women.
Acknowledgments
The authors thank the study subjects for their participation, the study staff for their help in conducting this study, and the LIFE-Moms consortium members for their contributions to the development and oversight of the common measures and procedures shared across the trials. All data generated from this project will be administered in accordance with both University and NIH policies, including the most current NIH Data Release and Resource Sharing policy. The results from this work will be presented at scientific meetings and published in scientific journals and made freely available to the public according to NIH guidelines.
Sources of Support: This study was supported by the National Institutes of Health grants DK94416, DK56341 (Nutrition Obesity Research Center), DK092950 (Center for Diabetes Translation Research), DK20579 (Diabetes Research Center) and RR024992 (Clinical and Translational Science Award). LIFE-Moms is supported by the National Institutes of Health through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, U01 DK094418, U01 DK094463, U01 DK094416, 5U01 DK094466 (RCU)), the National Heart, Lung, and Blood Institute (NHLBI, U01 HL114344, U01 HL114377), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD, U01 HD072834), the National Center for Complementary and Integrative Health (NCCIH), the NIH Office of Research in Women’s Health (ORWH), the Office of Behavioral and Social Science Research (OBSSR), the Indian Health Service, and the Intramural Research Program of the NIDDK. We thank the LIFE-Moms consortium members for their contributions to the development and oversight of the common measures and procedures shared across the trials.
Footnotes
Disclosure: The authors declared no conflict of interest.
Clinical Trials Registration: ClinicalTrials.gov: NCT01768793; Weight Management in Obese Pregnant Underserved African American Women
Contributor Information
Debra Haire-Joshu, Brown School and Department of Medicine, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Alison G. Cahill, Department of Obstetrics and Gynecology, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Richard I. Stein, Center for Human Nutrition, Washington University in St. Louis, St. Louis, Missouri, 63110.
W. Todd Cade, Program in Physical Therapy, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Candice L. Woolfolk, Department of Obstetrics and Gynecology, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Kelle Moley, Department of Obstetrics and Gynecology, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Amit Mathur, Department of Pediatrics, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Cynthia D. Schwarz, Brown School and Department of Medicine, Washingt on University in St. Louis, St. Louis, Missouri, USA.
Kenneth B. Schechtman, Department of Biostatistics, Washington University in St. Louis, St. Louis, Missouri, 63110.
Samuel Klein, Center for Human Nutrition, Washington University in St. Louis, St. Louis, Missouri, 63110.
References
- 1.Meng Y, Groth SW, Stewart P, Smith JA. An Exploration of the Determinants of Gestational Weight Gain in African American Women: Genetic Factors and Energy Expenditure. Biol Res Nurs. 2018;20(2):118–25. doi: 10.1177/1099800417743326. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Shepherd E, Gomersall JC, Tieu J, Han S, Crowther CA, Middleton P. Combined diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2017;11:CD010443. doi: 10.1002/14651858.CD010443.pub3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Spencer L, Rollo M, Hauck Y, MacDonald-Wicks L, Wood L, Hutchesson M, et al. The effect of weight management interventions that include a diet component on weight-related outcomes in pregnant and postpartum women: a systematic review protocol. JBI Database System Rev Implement Rep. 2015;13(1):88–98. doi: 10.11124/jbisrir-2015-1812. [DOI] [PubMed] [Google Scholar]
- 4.Herring SJ, Cruice JF, Bennett GG, Rose MZ, Davey A, Foster GD. Preventing excessive gestational weight gain among African American women: A randomized clinical trial. Obesity (Silver Spring). 2016;24(1):30–6. doi: 10.1002/oby.21240. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Widen EM, Whyatt RM, Hoepner LA, Ramirez-Carvey J, Oberfield SE, Hassoun A, et al. Excessive gestational weight gain is associated with long-term body fat and weight retention at 7 y postpartum in African American and Dominican mothers with underweight, normal, and overweight prepregnancy BMI. Am J Clin Nutr. 2015;102(6):1460–7. doi: 10.3945/ajcn.115.116939. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Gould Rothberg BE, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Gestational weight gain and subsequent postpartum weight loss among young, low-income, ethnic minority women. Am J Obstet Gynecol. 2011;204(1):52 e1–11. doi: 10.1016/j.ajog.2010.08.028. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, et al. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017;317(21):2207–25. doi: 10.1001/jama.2017.3635. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Salvy SJ, de la Haye K, Galama T, Goran MI. Home visitation programs: an untapped opportunity for the delivery of early childhood obesity prevention. Obes Rev. 2017;18(2):149–63. doi: 10.1111/obr.12482. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Haire-Joshu DL, Schwarz CD, Peskoe SB, Budd EL, Brownson RC, Joshu CE. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program. Int J Behav Nutr Phys Act. 2015;12:88. doi: 10.1186/s12966-015-0247-8. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Thomson JL, Tussing-Humphreys LM, Goodman MH, Olender SE. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial. J Pregnancy. 2016;2016:5703607. doi: 10.1155/2016/5703607. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Johnston LM, Finegood DT. Cross-sector partnerships and public health: challenges and opportunities for addressing obesity and noncommunicable diseases through engagement with the private sector. Annu Rev Public Health. 2015;36:255–71. doi: 10.1146/annurev-publhealth-031914-122802. [DOI] [PubMed] [Google Scholar]
- 12.Gittelsohn J, Trude A. Diabetes and obesity prevention: changing the food environment in low-income settings. Nutr Rev. 2017;75(suppl 1):62–9. doi: 10.1093/nutrit/nuw038. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Heslehurst N, Newham J, Maniatopoulos G, Fleetwood C, Robalino S, Rankin J. Implementation of pregnancy weight management and obesity guidelines: A meta-synthesis of healthcare professionals’ barriers and facilitators using the Theoretical Domains Framework. Pregnancy Hypertens. 2014;4(3):234–5. doi: 10.1016/j.preghy.2014.03.017. [DOI] [PubMed] [Google Scholar]
- 14.Shelton SL, Lee SS. Women’s Self-Reported Factors That Influence Their Postpartum Exercise Levels. Nurs Womens Health. 2018;22(2):148–57. doi: 10.1016/j.nwh.2018.02.003. [DOI] [PubMed] [Google Scholar]
- 15.Parents as Teachers, Affiliate Plan: the Initial Step for Implementation of the Parents as Teachers Model. 2017. https://parentsasteachers.org/getting-started.
- 16.Parents As Teachers. Annual Report 2016–2017. http://parentsasteachers.org/annualreport.
- 17.Haire-Joshu D, Brownson RC, Nanney MS, Houston C, Steger-May K, Schechtman K, et al. Improving dietary behavior in African Americans: the Parents As Teachers High 5, Low Fat Program. Prev Med. 2003;36(6):684–91. [DOI] [PubMed] [Google Scholar]
- 18.Haire-Joshu D, Elliott MB, Caito NM, Hessler K, Nanney MS, Hale N, et al. High 5 for Kids: the impact of a home visiting program on fruit and vegetable intake of parents and their preschool children. Prev Med. 2008;47(1):77–82. doi: 10.1016/j.ypmed.2008.03.016. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Haire-Joshu D, Schwarz CD, Steger-May K, Lapka C, Schechtman K, Brownson RC, et al. A Randomized Trial of Weight Change in a National Home Visiting Program. Am J Prev Med. 2018;54(3):341–51. doi: 10.1016/j.amepre.2017.12.012. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Cahill AG, Haire-Joshu D, Cade WT, Stein RI, Woolfolk CL, Moley K, et al. Weight Control Program and Gestational Weight Gain in Disadvantaged Women with Overweight or Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2018;26(3):485–91. doi: 10.1002/oby.22070. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, et al. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016;24(2):305–13. doi: 10.1002/oby.21330. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Zigler E, Pfannenstiel JC, Seitz V. The Parents as Teachers program and school success: a replication and extension. J Prim Prev. 2008;29(2):103–20. doi: 10.1007/s10935-008-0132-1. [DOI] [PubMed] [Google Scholar]
- 23.Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Spahn JM, Reeves RS, Keim KS, Laquatra I, Kellogg M, Jortberg B, et al. State of the evidence regarding behavior change theories and strategies in nutrition counseling to facilitate health and food behavior change. J Am Diet Assoc. 2010;110(6):879–91. doi: 10.1016/j.jada.2010.03.021. [DOI] [PubMed] [Google Scholar]
- 25.Institute of Medicine; National Research Council, Rasmussen KM, Yaktine AL, eds. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington, DC: National Acasemies Press; 2009. [PubMed] [Google Scholar]
- 26.Vesco KK, Leo MC, Karanja N, Gillman MW, McEvoy CT, King JC, et al. One-year postpartum outcomes following a weight management intervention in pregnant women with obesity. Obesity (Silver Spring). 2016;24(10):2042–9. doi: 10.1002/oby.21597. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.International Weight Management in Pregnancy Collaborative G. Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials. BMJ. 2017;358:j3119. doi: 10.1136/bmj.j3119. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Craigie AM, Macleod M, Barton KL, Treweek S, Anderson AS, WeighWell t. Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial. Eur J Clin Nutr. 2011;65(8):952–8. doi: 10.1038/ejcn.2011.56. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Huvinen E, Koivusalo SB, Meinila J, Valkama A, Tiitinen A, RoNo K, et al. Effects of a Lifestyle Intervention During Pregnancy and First Postpartum Year - Findings from the RADIEL study. J Clin Endocrinol Metab. 2018. doi: 10.1210/jc.2017-02477. [DOI] [PubMed] [Google Scholar]
- 30.Gross SM, Augustyn M, Henderson JL, Baig K, Williams CA, Ajao B, et al. Integrating Obstetrical Care and WIC Nutritional Services to Address Maternal Obesity and Postpartum Weight Retention. Matern Child Health J. 2018;22(6):794–802. doi: 10.1007/s10995-018-2449-6. [DOI] [PubMed] [Google Scholar]
- 31.Walker LO, Sterling BS, Latimer L, Kim SH, Garcia AA, Fowles ER. Ethnic-specific weight-loss interventions for low-income postpartum women: findings and lessons. West J Nurs Res. 2012;34(5):654–76. doi: 10.1177/0193945911403775. [DOI] [PubMed] [Google Scholar]
- 32.Tussing-Humphreys LM, Thomson JL, Hemphill NO, Goodman MH, Landry AS. Maternal weight in the postpartum: results from the Delta healthy sprouts trial. Matern Health Neonatol Perinatol. 2017;3:20. doi: 10.1186/s40748-017-0058-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33.Zheng Y, Manson JE, Yuan C, Liang MH, Grodstein F, Stampfer MJ, et al. Associations of Weight Gain From Early to Middle Adulthood With Major Health Outcomes Later in Life. JAMA. 2017;318(3):255–69. doi: 10.1001/jama.2017.7092. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 34.Gunderson EP. Childbearing and obesity in women: weight before, during, and after pregnancy. Obstet Gynecol Clin North Am. 2009;36(2):317–32, ix. doi: 10.1016/j.ogc.2009.04.001. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 35.Linne Y, Dye L, Barkeling B, Rossner S. Long-term weight development in women: a 15-year follow-up of the effects of pregnancy. Obes Res. 2004;12(7):1166–78. doi: 10.1038/oby.2004.146. [DOI] [PubMed] [Google Scholar]
- 36.Endres LK, Straub H, McKinney C, Plunkett B, Minkovitz CS, Schetter CD, et al. Postpartum weight retention risk factors and relationship to obesity at 1 year. Obstet Gynecol. 2015;125(1):144–52. doi: 10.1097/AOG.0000000000000565. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 37.Ostbye T, Peterson BL, Krause KM, Swamy GK, Lovelady CA. Predictors of postpartum weight change among overweight and obese women: results from the Active Mothers Postpartum study. J Womens Health (Larchmt). 2012;21(2):215–22. doi: 10.1089/jwh.2011.2947. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 38.Lee E, Mitchell-Herzfeld SD, Lowenfels AA, Greene R, Dorabawila V, DuMont KA. Reducing low birth weight through home visitation: a randomized controlled trial. Am J Prev Med. 2009;36(2):154–60. doi: 10.1016/j.amepre.2008.09.029. [DOI] [PubMed] [Google Scholar]
- 39.Wing RR, Hamman RF, Bray GA, Delahanty L, Edelstein SL, Hill JO, et al. Achieving weight and activity goals among diabetes prevention program lifestyle participants. Obes Res. 2004;12(9):1426–34. doi: 10.1038/oby.2004.179. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 40.Jackson L Translating the Diabetes Prevention Program into practice: a review of community interventions. Diabetes Educ. 2009;35(2):309–20. doi: 10.1177/0145721708330153. [DOI] [PubMed] [Google Scholar]


