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Behavioral Intervention

Antenatal Obesity Treatment for Pregnancy-Related Obesity (GWG Trial)

N/A

Waitlist Available

Led By Sharon J Herring, MD, MPH

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Prior bariatric surgery

Diagnosis contraindicating weight control (e.g., hyperemesis gravidarum)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month pp

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an obesity treatment can help lower weight gain during pregnancy when given through the Women, Infants, and Children program in Philadelphia.

Who is the study for?

This trial is for African American or Hispanic women who are part of the Philadelphia WIC program, have a BMI ≥ 25 kg/m2, and are less than 16 weeks pregnant. They must own a cell phone with unlimited texting and be able to do light exercises like walking. Women with certain medical conditions or those who've had bariatric surgery can't join.

What is being tested?

The study is testing an antenatal obesity treatment (AO) designed to manage weight gain during pregnancy. It's integrated into the Philadelphia WIC program and involves receiving texts as part of the intervention.

What are the potential side effects?

Since this trial focuses on lifestyle interventions such as diet control and physical activity rather than medication, side effects may include typical exercise-related discomforts but should not involve drug-related adverse reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have a condition that makes it unsafe for me to control my weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month pp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month pp

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month pp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in maternal weight

Proportion of women with excessive gestational weight gain

Secondary study objectives

Change in Dietary intake

Change in accelerometer-measured physical activity

Change in maternal 12-month weight postpartum (pp)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antenatal Obesity Treatment (AO)Experimental Treatment1 Intervention

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.

Group II: WIC Standard Care (SC)Active Control1 Intervention

Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.

0 / 2Eligibility criteria met