Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:July 1, 2018
End Date:June 30, 2023

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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.

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.

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
We found this trial at
1
site
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
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