Temple University
Philadelphia, Pennsylvania, 19140, United States
NCT Number: NCT03707834
The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.
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Notify Me18 year and older
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19140, United States
Institute of Medicine (IOM) guidelines for weight gain in pregnancy are clear, but evidence-based treatment approaches are not widely available. This evidence gap is particularly pressing for medically vulnerable women - those who are low income and often racial/ethnic minorities. These women have the highest rates of obesity, but almost no resources to support weight control in pregnancy. Without intervention, most will exceed Institute of Medicine recommended gains and incur significant morbidity for themselves and their children. There is preliminary data from the investigators supporting the efficacy of digital health platforms for delivering antenatal obesity treatment among the medically vulnerable. However, the investigators' inexpensive, easily scalable approach has not been integrated and tested in real world settings, limiting broad reach and dissemination potential. Dissemination considerations are especially pressing for socioeconomically disadvantaged and minority populations because of these groups' higher obesity risk, greater potential for experiencing obesity-related comorbidities in pregnancy, and limited finances to afford alternative treatments. The Women, Infants and Children (WIC) Food and Nutrition Program is the leading public health nutrition program for pregnant women and their children in the US, and thus, it is in a unique position to meaningfully impact the obesity epidemic among the more than 9 million disadvantaged participants it serves annually. Yet no demonstrations of effective gestational weight gain interventions exist in WIC. The investigators propose a pragmatic trial designed to rigorously test their antenatal obesity treatment approach integrated into Philadelphia WIC community clinics. The investigators have long-standing relationships with WIC staff and prior experience conducting pragmatic clinical trials in under-resourced settings. The investigators will randomize 438 African American and Hispanic Philadelphia County WIC participants with obesity in early pregnancy to one of two treatment arms: 1) standard WIC care; or 2) an antenatal obesity treatment arm, which includes empirically supported behavior change goals, regular self-monitoring text messages with automated feedback, tailored skills training materials, and counseling from WIC nutritionists. The primary outcome is prevalence of excessive gestational weight gain; the investigators will additionally examine changes in diet and physical activity, health-related quality of life, and rates of adverse pregnancy outcomes. They will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate the intervention's dissemination potential and cost effectiveness in the WIC setting. The proposed project will constitute the first systematic translation of a comprehensive antenatal obesity treatment program focused on low-income, racial/ethnic minorities, using the strengths of mHealth (mobile health) and WIC provider counseling for intervention delivery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
Time frame: End of Pregnancy (36-38 weeks' gestation)
Excessive weight gain is defined as the percentage of mothers exceeding weekly IOM weight gain targets (>0.32 kg/week for BMI 25-29.9 kg/m2; >0.27 kg/week for BMI ≥30 kg/m2) over the study period (from enrollment to end of pregnancy).
Time frame: At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)
Weight gain will be calculated as the difference between weight in kilograms measured at 36-38 weeks' gestation and baseline weight.
Time frame: Baseline and 36-38 weeks' gestation
Will be measured using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool, a web application developed by NCI. We will collect 3 separate 24-hour dietary recalls (1 weekend day, 2 weekdays) at baseline and 36-38 weeks' gestation.
Time frame: Delivery
Evaluated via medical record abstraction
Time frame: Delivery
Evaluated via medical record abstraction
Time frame: At baseline and 6-month PP
Weight change will be calculated as the difference between mean 6-month PP weight and baseline weight in kilograms.
Time frame: At baseline and 12-month PP
Weight change will be calculated as the difference between mean 12-month PP weight and baseline weight in kilograms.
Temple University
Other
Acronym: GWG
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