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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to managing weight during pregnancy, called Antenatal Obesity Treatment (AO), for expectant mothers in Philadelphia's WIC program. The focus is on African American or Hispanic women with a BMI of 25 or more, who are no more than 16 weeks pregnant. Participants will receive support through goal setting, self-monitoring, and other strategies to manage weight gain. Those comfortable with light to moderate exercise and able to receive text messages may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could benefit future pregnancies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a pre-existing medical condition that affects weight, you may not be eligible to participate.

What prior data suggests that this antenatal obesity treatment is safe for pregnancy-related obesity?

Research has shown that managing obesity during pregnancy can improve health outcomes for both mothers and their babies. One study found these methods safe and effective, even when resulting in less weight gain than typically recommended or some weight loss during pregnancy. This indicates the treatment is generally well-tolerated, with few negative effects reported.

Evidence supports the safety of this approach for pregnant individuals with obesity. However, discussing any concerns with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Antenatal Obesity Treatment (AO) because it offers a fresh approach to managing pregnancy-related obesity. Unlike standard care options that often focus solely on general dietary and exercise advice, AO integrates a multi-component strategy. This includes personalized goal setting, self-monitoring, and behavioral skills training, along with interpersonal support and social modeling. By addressing weight-related behaviors in a comprehensive manner, AO has the potential to provide more effective and sustainable results for pregnant women struggling with obesity.

What evidence suggests that the Antenatal Obesity Treatment is effective for pregnancy-related obesity?

Research has shown that managing obesity in pregnant women can reduce health problems for both mothers and their babies. In this trial, participants in the Antenatal Obesity Treatment (AO) arm will engage in a multi-component intervention that includes setting goals, tracking progress, and receiving support from others. Studies have found that when pregnant women with obesity control their weight gain, it lowers the risk of complications during pregnancy and childbirth. A review of several high-quality studies supports these methods, showing they can lead to better health for mothers and babies. Overall, evidence suggests that addressing obesity in pregnancy can lead to healthier outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Sharon J. Herring, MD, MPH

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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.

Shared phone

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318269/

A Systematic Review of the Management of Maternal Obesity ... This systematic review synthesizes evidence from eight high-quality studies published between 2015 and 2024, discussing the management of ...

2. nature.com nature.com/articles/s41366-025-01748-y

The effect of methods used in the management of maternal ... The study revealed that methods used in the treatment of maternal obesity may reduce some negative maternal and newborn outcomes.

3. mdpi.com mdpi.com/2227-9032/13/15/1893

Impact of Maternal Overweight and Obesity on Pregnancy ... Maternal overweight and obesity significantly increase the risk of complications during pregnancy, labor, and the perinatal period for the child. Additionally, ...

4. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03342-2

Maternal obesity management: a narrative literature review of ... Pregnant women with obesity are advised to restrict gestational weight gain to 5–9 kg to enhance outcomes. Postpartum, weight loss is encouraged ...

5. cureus.com cureus.com/articles/321195-obesity-prevalence-and-its-impact-on-maternal-and-neonatal-outcomes-in-pregnant-women-a-systematic-review

Obesity Prevalence and Its Impact on Maternal ... There is a high level of evidence that maternal obesity is associated with a range of adverse pregnancy complications and neonatal outcomes.

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)00255-1/abstract

Safety of low weight gain or weight loss in pregnancies ... In this study we investigated the safety of gestational weight gain below current recommendations or weight loss in pregnancies with obesity.

7. aafp.org aafp.org/pubs/afp/issues/2018/0501/p559.html

Obesity in Pregnancy: Risks and Management Obesity during pregnancy also increases the odds of spontaneous and recurrent miscarriages, suboptimal ultrasound screening for fetal anomalies, congenital ...

8. mayoclinic.org mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/pregnancy-and-obesity/art-20044409

Pregnancy and obesity: Know the risks During pregnancy, obesity can have a major impact on a pregnant person's health. Obesity also can affect the health of an unborn baby, called a fetus.