Antenatal Obesity Treatment for Pregnancy-Related Obesity

(GWG Trial)

Overseen By Jessica J Albert, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Diabetes, HIV, Thyroid disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36-38 weeks

416 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Sharon J. Herring, MD, MPH

Principal Investigator

Temple University

Eligibility Criteria

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.

Inclusion Criteria

BMI ≥ 25 kg/m2

Gestational age ≤16 weeks' (measured using last menstrual period)

I can walk and do some light to moderate physical activities.

Exclusion Criteria

I have had weight loss surgery in the past.

I have a health condition like diabetes or thyroid issues that can affect my weight.

Shared phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive antenatal obesity treatment integrated into WIC, including behavior change goals, self-monitoring, and counseling

36-38 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of maternal and infant weight and health outcomes

12 months postpartum

Treatment Details

Interventions

• Antenatal Obesity Treatment (AO)

Trial Overview 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.

Participant Groups

Group I: Antenatal Obesity Treatment (AO) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+