Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.

Detailed Description
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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.

Official Title
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Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Conditions
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Obesity, Overweight, Pregnancy Related

Intervention / Treatment
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* Behavioral: Antenatal Obesity Treatment (AO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 25 kg/m2 Self-identify as African American or Hispanic Gestational age ≤16 weeks' (measured using last menstrual period) Philadelphia WIC participant Willingness to receive study texts Own a cell phone with an unlimited text messaging plan Able to participate in light to moderate physical activity (walking) Exclusion Criteria: Prior bariatric surgery Pre-existing medical condition that could influence weight (e.g., diabetes, HIV, thyroid disorder, bulimia, anorexia, gallbladder disease) Diagnosis contraindicating weight control (e.g., hyperemesis gravidarum) Shared phone Multiple pregnancy (e.g., twins) Current and/or previous participant for our Temple-led obesity treatment interventions in pregnancy or the postpartum period Serious or unstable medical or psychological conditions that, in the opinion of the PI, would compromise the subject's safety for successful participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: WIC Standard Care (SC)<br>Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC. | |
| Experimental: Antenatal Obesity Treatment (AO)<br>The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies. | Behavioral: Antenatal Obesity Treatment (AO)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women with excessive gestational weight gain | Excessive weight gain is defined as gaining above the upper end of IOM total weight gain ranges for singleton pregnancies (>11.5 kg for overweight BMI; >9 kg for obese BMI). Weight will be measured using a calibrated scale at baseline and 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. | End of Pregnancy (36-38 weeks' gestation) | 
| Change in maternal weight | Weight will be measured using a calibrated scale at baseline and 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. | At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dietary intake | 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. | Baseline and 36-38 weeks' gestation | 
| Change in accelerometer-measured physical activity | Will be assessed at baseline and 36-38 weeks' gestation using accelerometers (ActiGraph GT3X+), worn on participants' hip for 7 days. | Baseline and 36-38 weeks' gestation | 
| Proportion with glucose intolerance (mild hyperglycemia, gestational diabetes) | Evaluated via medical record abstraction | Delivery | 
| Proportion with hypertension | Evaluated via medical record abstraction | Delivery | 
| Change in maternal 6-month weight postpartum (pp) | Weight will be measured using a calibrated scale at baseline and 6-month postpartum(PP). Weight loss will be calculated as the difference between mean 6-month PP and baseline weight in kilograms. | At baseline and 6-month PP | 
| Change in maternal 12-month weight postpartum (pp) | Weight will be measured using a calibrated scale at baseline and 12-month PP. Weight loss will be calculated as the difference between mean 12-month PP and baseline weight in kilograms. | At baseline and 12-month PP | 
| Infant weight (6-month pp) | Infant weight will be measured at 6-months of age to assess maintenance of intervention effects on infant weight. | 6-month PP | 
| Infant length (6-month pp) | Infant length will be measured at 6-months of age to assess maintenance of intervention effects on infant length. | 6-month PP | 
| Infant weight (12-month pp) | Infant weight will be measured at 12-months of age to assess maintenance of intervention effects on infant weight. | 12-month PP | 
| Infant length (12-month pp) | Infant length will be measured at 12-months of age to assess maintenance of intervention effects on infant length. | 12-month PP |