Background: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking. Objective: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits. Methods: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application. Results: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023. Conclusions: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC. Trial Registration: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843
Background: Underserved pregnant women have a greater risk of excessive or inadequate gestational weight gain (GWG) and adverse perinatal outcomes. In the United States, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides supplemental nutrition and is uniquely positioned to deliver equitable interventions that support recommended GWG. Yet to date, no randomized controlled trials have evaluated behavioral strategies for managing GWG in this setting. Objective: The primary objective was to examine the effects of a statewide randomized multicomponent mobile eHealth lifestyle intervention trial on change in physical activity and sedentary time across pregnancy. The secondary objective was to explore associations between changes in physical activity, sedentary time, and GWG. Methods: A total of 351 pregnant women were recruited from the Louisiana WIC clinics and were randomly assigned to a multicomponent mobile eHealth intervention for GWG management (N=179) or usual care (N=172; standard in-person WIC care) prior to 16 weeks of gestation. The multicomponent mobile intervention included daily weighing, step tracking, counseling, exercise videos, health coach interactions, and social support. For the first objective, physical activity, including movement duration and movement context, and sedentary time were assessed at baseline (early pregnancy) and at the end of the intervention (late pregnancy) using accelerometry and the Pregnancy Physical Activity Questionnaire. For the second objective, GWG was determined based on weight collected at study visits in early and late pregnancy. Linear mixed models assessed intervention effects on physical activity and GWG. Results: Both the Intervention Group and the Usual Care Group significantly increased sedentary time from early to late pregnancy (adjusted effect estimate [95% CI] 62 minutes per day (42-83), P<.001 and 52 minutes per day (31-72), P<.001, respectively). Both the Intervention Group and the Usual Care Group significantly decreased moderate activity (–13 minutes per day (–20 to –6), P<.001 and –10 minutes per day (–17 to –3), P=.01, respectively) and total moderate to vigorous physical activity (–14 minutes per day (–21 to –7), P<.001 and –10 minutes per day (–18 to –3), P=.01, respectively) from early to late pregnancy. For the Pregnancy Physical Activity Questionnaire, the Intervention Group reported an increase in sports participation across pregnancy compared with the Usual Care Group (+4 metabolic equivalent task (MET)–hours per week (2-7); P=.002). There were no associations between physical activity (–7 g (–32 to 18), P=.57) or sedentary time measures (4 g (–4 to 12), P=.31) and GWG. Conclusions: The first of its kind mobile eHealth multicomponent behavioral lifestyle intervention that included guidance to increase physical activity toward national guidelines did not meaningfully impact physical activity outcomes in pregnant women who were enrolled in Louisiana WIC. Trial Registration: ClinicalTrials.gov NCT04028843; https://www.clinicaltrials.gov/study/NCT04028843