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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

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:
Select...
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 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

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.

Find a Location

Who is running the clinical trial?

Temple UniversityLead Sponsor
313 Previous Clinical Trials
87,881 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,475 Total Patients Enrolled
Sharon J Herring, MD, MPHPrincipal InvestigatorTemple University
2 Previous Clinical Trials
694 Total Patients Enrolled

Media Library

Antenatal Obesity Treatment (AO) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03707834 — N/A
Pregnancy Research Study Groups: Antenatal Obesity Treatment (AO), WIC Standard Care (SC)
Pregnancy Clinical Trial 2023: Antenatal Obesity Treatment (AO) Highlights & Side Effects. Trial Name: NCT03707834 — N/A
Antenatal Obesity Treatment (AO) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03707834 — N/A
~16 spots leftby Dec 2024
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