Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus.

BACKGROUND: Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking. OBJECTIVE: This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus. STUDY DESIGN: A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods. RESULTS: In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns=38/102 [37%] intervention vs 25/91 [28.0%] control; P=.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 [3.4-6.0] vs 0.7 [-0.9 to 2.3] kg; P=.001) and a greater proportion lost ≥5% of body weight (50.0% [17/34] vs 13.6% [3/22]; P=.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% [ns=23/38]) and the control group (44.0% [ns=11/25]; odds ratio, 1.8 [0.59-5.8]). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 [0.66-0.94]; P=.008). A ≥5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 [0.04-0.88]; P=.03). CONCLUSION: Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered.

Mi Gente, Nuestra Salud: Protocol for a People's Movement for Health Ownership.

BACKGROUND: Community-based participatory research (CBPR) is an increasingly recognized approach to address health inequities. Although in CBPR all processes occur within the community context, its diagrammatic model places the intervention/research outside of the community rather than conceptualizing it as an event in a complex web of system components. OBJECTIVES: We sought to 1) introduce a systems-oriented community ownership conceptual framework that integrates a systems perspective with CBPR and 2) to describe an application of this framework in the form of the Mi Gente, Nuestra Salud initiative, a research-based, action-oriented collaboration between Cal Poly investigators and community partners in Santa Maria and Guadalupe, California. METHODS: We conducted a stocktake of community assets and partnerships in Santa Maria and Guadalupe, among California's poorest and most medically underserved cities; created marketing materials; launched the initiative in December 2020; and collected survey and interview data on community health concerns. An advisory board guides direction of the work. Activities are intended to affect partnerships (who is involved in actions and decisions) and processes (what actions will be taken), as well as resources (e.g., building human and social capital by changing narratives of local, historically rooted power dynamics and offering peer learning opportunities on advocacy and health care interactions). Implementation challenges within this framework are also discussed. CONCLUSIONS: By de-centering specific interventions and conceptualizing them as single events in a complex web, our system-oriented community ownership model brings the focus back to the system itself, and to system-based processes and solutions, while still guided by CBPR principles.

Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.

Effect of prenatal lifestyle intervention on maternal postpartum weight retention and child body mass index z-score at 36 months.

BACKGROUND/OBJECTIVES: We previously reported results from a randomized trial showing that a behavioral intervention during pregnancy reduced excess gestational weight gain but did not impact maternal weight at 12 months. We now examine the longer-term effects of this prenatal intervention on maternal postpartum weight retention and toddler body-mass-index z scores (BMIz) over 36 months. SUBJECTS/METHODS: Pregnant women (N = 264; 13.7 weeks' gestation; 41.6% Hispanic) with overweight or obesity were randomized into usual care or prenatal intervention. Anthropometric assessments in mothers and toddlers occurred at baseline, 35 weeks' gestation and after delivery at 6, 12, 18, 24, and 36 months. RESULTS: At 36 months, prenatal intervention vs. usual care had no significant effect on the proportion of participants who returned to their early pregnancy weight or below (33.3% vs. 39.5%; p = 0.12) and had no effect on the magnitude of weight retained (2.8 [0.8, 4.8] vs 3.0 kg [1.0, 4.9], respectively; mean difference = 0.14 [-3.0, 2.7]). There was also no statistically significant intervention vs. usual care effect on infant BMIz or skinfold changes over time; toddler BMIz increased by 1.4 [-1.7, 1.0] units in the intervention group and 1.6 [-1.2, 1.8] units in the usual care group from delivery to 36 months (difference = 0.16 [-0.32. 0.63]). The proportion of toddlers at risk for obesity at 36 months was similar in intervention and usual care groups (28/77 [36.4%] vs 30/80 [37.5%]; p = 0.77). CONCLUSIONS: Compared with usual care, lifestyle intervention during pregnancy resulted in similar maternal and toddler anthropometric outcomes at 36-months postpartum in a diverse US sample of women with overweight and obesity. To sustain improved maternal weight management initiated during pregnancy, continued intervention during the postpartum years may be needed.

Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss.

OBJECTIVE: This cluster randomized trial tested whether an effective internet-based weight-loss intervention for low-income, postpartum women resulted in greater improvements in targeted social cognitive theory (SCT) constructs and psychosocial outcomes. METHODS: Fit Moms/Mamás Activas was a 12-month cluster randomized controlled trial of 370 postpartum women at 12 Special Supplemental Nutrition Program for Women, Infants, Children (WIC) clinics that were randomly assigned to intervention or standard WIC. SCT constructs (weight-control behaviors, cognitive restraint, disinhibition, self-efficacy, social support, body image) and psychosocial outcomes (depressive symptoms and stress) were measured at study entry and after 6 and 12 months. RESULTS: The intervention versus standard WIC resulted in greater 12-month increases in weight-control behaviors (3.28 points [95% CI: 1.06-5.50]), self-monitoring of weight and eating (2.28 points [1.17-3.40]), and cognitive restraint (1.93 points [0.78-3.08]) (all P ≤ 0.004). The intervention effect was only modestly (ηp 2 = 0.02) mediated by improvements in these factors. No significant group by time effect was observed for disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress. CONCLUSIONS: Among low-income postpartum women, an effective internet-based weight-loss program resulted in improved weight-control behaviors and cognitive restraint but did not affect other SCT targets and psychosocial outcomes.

Engagement and Weight Loss in a Web and Mobile Program for Low-Income Postpartum Women: Fit Moms/Mamás Activas.

Internet-based weight loss programs can be effective in promoting weight loss and are less-intensive than traditional face-to-face approaches, which may provide more flexibility for postpartum, low-income women to engage in such programs. Few studies have examined patterns of engagement in internet-based programs for this population. This article used data from the internet-based Fit Moms/Mamás Activas intervention, a 12-month cluster randomized controlled trial that was effective in promoting postpartum weight loss among low-income, predominantly Hispanic women. The overall objectives of this study were to (1) characterize patterns of engagement with the Fit Moms/Mamás Activas website among intervention participants and (2) explore associations between engagement and 12-month weight loss outcomes among study completers (87.4%). A number of engagement variables were calculated for each participant, including website logins; time spent on the website; number of posts to the "Discussion Forum;" number of days tracking weight, diet, and physical activity; number of page visits to various website components; and number of in-person visits attended. The average number of logins was 70.74 (approximately once weekly), and average total time spent on the website was 185.35 minutes (approximately 3 hours) over 1 year. Self-monitoring ("Web Diary") and social support ("Discussion Forum") were the most frequently visited components of the website, and more frequent engagement with these components, as well as greater attendance at in-person group sessions, predicted greater percent weight loss at 12 months. Interventions highlighting these features may be particularly effective for weight loss in this population.

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention?

OBJECTIVE: This randomized trial tested whether a behavioral intervention with meal replacements in pregnancy could increase the proportion of women who returned to prepregnancy weight and reduce postpartum weight retention by 12 months after delivery. METHODS: Women (N = 264; 13.7 weeks' gestation) with overweight or obesity were randomly assigned to usual care or intervention. The intervention reduced excess gestational weight gain and was discontinued at delivery. At follow-up, 83.7% completed the 12-month assessment. RESULTS: Compared with usual care, prenatal intervention had no significant effect on odds of achieving prepregnancy weight (38/128 [29.7%] vs. 41/129 [31.8%]; P = 0.98) or in reducing the magnitude of weight retained (3.3 vs. 3.1 kg; P = 0.82) at 12 months. After delivery, significant (P < 0.0001) declines in meal replacements, practice of weight control behaviors, and dietary restraint were observed in the intervention group. Independent of group, lower gestational weight gain was the strongest predictor of achieving prepregnancy weight at 12 months (P = 0.0008). CONCLUSIONS: A prenatal behavioral intervention with meal replacements that reduced pregnancy weight gain had no significant effect on 12-month postpartum weight retention.

Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain.

Background: Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. Objective: A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care. Design: Participants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257). Results: The intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (ß = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03). Conclusion: Prenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.

Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women.

BACKGROUND: Low-income Hispanic women experience elevated rates of high postpartum weight retention (PPWR), which is an independent risk factor for lifetime obesity. Sociocultural factors might play an important role among Hispanic women; however, very few studies have examined this association. OBJECTIVE: The purpose of our study was to examine the associations between acculturation and maternal diet, physical activity, and PPWR. DESIGN: This is a cross-sectional study of baseline data from 282 Hispanic women participating in the FitMoms/Mamás Activas study, a randomized controlled trial examining the impact of primarily an internet-based weight control program, in reducing PPWR among low-income women. We performed multivariable linear regression to examine the association of acculturation with diet quality, physical activity, and PPWR at study entry. RESULTS: A total of 213 (76%) women had acculturation scores reflecting Mexican orientation or bicultural orientation, whereas 69 (24%) had scores that represented assimilation to Anglo culture. Women who were more acculturated had lower intakes of fruits and vegetables, lower HEI scores, and lower physical activity levels than women who were less acculturated (p < 0.05). We found an association between acculturation and PPWR in that for every 1-unit increase in acculturation score, PPWR increased, on average, by 0.80 kg. CONCLUSION: Higher acculturation was associated with poorer diet and physical activity behaviors and greater PPWR.

Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial.

Importance: Postpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women. Objective: To test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months. Design, Setting, and Participants: A 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016. Interventions: Clinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics. Main Outcomes and Measures: The primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet. Results: Participants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P < .001; difference, 2.3 kg (95% CI, 1.1 to 3.5). More participants in the intervention group than the standard care group returned to preconception weight by 12 months (32.8% in the intervention group vs 18.6% in the standard care group, P < .001; difference, 14.2 percentage points [95% CI, 4.7 to 23.5]). The intervention group and standard care group did not significantly differ in 12-month changes in physical activity (mean [95% CI]: -7.8 min/d [-16.1 to 0.4] in the intervention group vs -7.2 min/d [-14.6 to 0.3] in the standard care group; difference, -0.7 min/d [95% CI, -42.0 to 10.6], P = .76), calorie intake (mean [95% CI]: -298 kcal/d [-423 to -174] in the intervention group vs -144 kcal/d [-257 to -32] in the standard care group; difference, -154 kcal/d [-325 to 17], P = .06), or incidences of injury (16 in the intervention group vs 16 in the standard care group) or low breastmilk supply from baseline to month 6 (21 of 61 participants in the intervention group vs 23 of 72 participants in the standard care group) and from month 6 to 12 (13 of 32 participants in the intervention group vs 14 of 37 participants in the standard care group). Conclusions and Relevance: Among low-income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to determine program and cost-effectiveness as part of the WIC program. Trial Registration: clinicaltrials.gov Identifier: NCT01408147.

'Fit Moms/Mamás Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial.

BACKGROUND: High postpartum weight retention is a strong independent risk factor for lifetime obesity, cardiovascular disease, and type 2 diabetes in women. Interventions to promote postpartum weight loss have met with some success but have been limited by high attrition. Internet-based treatment has the potential to overcome this barrier and reduce postpartum weight retention, but no study has evaluated the effects of an internet-based program to prevent high postpartum weight retention in women. METHODS/DESIGN: Fit Moms/Mamás Activas targets recruitment of 12 Women, Infants and Children (WIC) Supplemental Nutrition Program clinics with a total of 408 adult (>18 years), postpartum (<1 year) women with 14.5 kg or more weight retention or a body mass index of 25.0 kg/m(2) or higher. Clinics are matched on size and randomly assigned within county to either a 12-month standard WIC intervention or to a 12-month WIC enhanced plus internet-based weight loss intervention. The intervention includes: monthly face-to-face group sessions; access to a website with weekly lessons, a web diary, instructional videos, and computer-tailored feedback; four weekly text messages; and brief reinforcement from WIC counselors. Participants are assessed at baseline, six months, and 12 months. The primary outcome is weight loss over six and 12 months; secondary outcomes include diet and physical activity behaviors, and psychosocial measures. DISCUSSION: Fit Moms/Mamás Activas is the first study to empirically examine the effects of an internet-based treatment program, coupled with monthly group contact at the WIC program, designed to prevent sustained postpartum weight retention in low-income women at high risk for weight gain, obesity, and related comorbidities. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT01408147 ) on 29 July 2011.