Health Interventions for Obesity During Pregnancy

(CHIME Trial)

Recruiting at 1 trial location

Overseen By Jennifer Woo Baidal Associate Professor, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Underweight, Gastrointestinal, Psychiatric, others

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

Compensation: Varies

Number of Visits: 5

795 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help pregnant women manage their weight during and after pregnancy. It tests three approaches: a community-based program, a self-management plan, and usual care. Participants receive guidance on nutrition, physical activity, and other support from early pregnancy until a year after giving birth. The trial aims to determine which method most effectively reduces weight retention. Women pregnant with one baby, planning to continue their pregnancy, and identifying as Black, Hispanic, or insured by Medicaid might be a good fit. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance weight management strategies for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that community programs can help pregnant women manage their weight and improve health. Some studies suggest these programs may lower the risk of excessive weight gain and gestational diabetes, which starts during pregnancy. Other research indicates these methods might reduce negative outcomes for mothers and babies.

For self-management, research indicates that changes in diet and exercise can help women control their weight after giving birth. Intensive lifestyle programs that begin post-pregnancy have successfully managed weight. These programs focus on self-monitoring and behavior changes, which can help reduce retained weight after pregnancy.

Overall, both community-based and self-management approaches appear safe and possibly effective for managing weight during and after pregnancy. Previous studies have shown these methods are generally well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new approaches for managing obesity during pregnancy because they offer more personalized and comprehensive support than traditional methods. The community-based intervention stands out by providing active social needs referrals and health coaching, which can empower pregnant individuals with the tools and resources they need directly from their community. Meanwhile, the self-management approach provides direct support for essentials like groceries and transportation, alongside self-directed behavior change tools, allowing for more autonomy and tailored lifestyle adjustments. These interventions aim to go beyond usual care, which typically involves standard lifestyle counseling and referrals, by integrating more holistic and accessible support systems for better health outcomes.

What evidence suggests that this trial's treatments could be effective for reducing maternal postpartum weight retention?

This trial will compare different interventions for managing obesity during pregnancy. Research has shown that community programs, one of the interventions in this trial, can help women gain less weight during pregnancy. Participants have reported benefits such as receiving support from others and gaining less weight through these programs. Studies that include both diet and exercise often lead to less weight gain and fewer cases of gestational diabetes.

Another intervention in this trial is self-management programs, which research suggests can help manage weight after giving birth. Significant lifestyle changes, like eating healthier and exercising more, can greatly reduce weight post-pregnancy. These programs also boost confidence in making healthy food choices and staying active. Both community and self-management approaches in this trial appear promising for managing weight during and after pregnancy. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals dealing with obesity or chronic diseases like diabetes. They should be interested in managing their weight during and after pregnancy. Participants will need to commit from early pregnancy until 12 months postpartum, completing questionnaires, dietary recalls, interviews, measurements, and blood tests.

Inclusion Criteria

Plans to continue receiving antenatal care at the recruitment site/network

I am pregnant with one baby, less than 20 weeks along, and plan to carry to term.

Exclusion Criteria

Underweight (BMI <18 kg/m2) at pre-pregnancy period

Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)

Multiple gestations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in one of the study interventions from early pregnancy until 12 months postpartum, including nutrition and physical activity counseling

12 months

5 visits (in-person)

Follow-up

Participants are monitored for maternal postpartum weight retention and other health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Community-Based
• Self-Management

Trial Overview The CHIME trial compares three approaches: usual care versus two multi-level interventions aimed at reducing maternal weight retention a year after giving birth. One intervention focuses on self-management while the other is community-based; both include nutrition and activity counseling.

How Is the Trial Designed?

Group I: Self-Management Experimental Treatment 1 Intervention

A self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care.

Group II: Community-Based Experimental Treatment 1 Intervention

A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.

Group III: Usual Care Active Control 1 Intervention

Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A review of randomized controlled trials found that dietary and lifestyle interventions during pregnancy for overweight or obese women did not show significant benefits compared to standard care for maternal or infant health outcomes.

Only two trials were identified, indicating a lack of sufficient research on the effectiveness and safety of these interventions, highlighting the need for more robust studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. Dodd, JM., Crowther, CA., Robinson, JS.[2022]

The IMPACT DIABETES Bump2Baby study is testing a mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) for women at risk of gestational diabetes, aiming to improve health behaviors during pregnancy and postpartum through personalized coaching and support.

This multicenter randomized controlled trial will involve 800 women across four countries and is designed to evaluate both the feasibility and effectiveness of the intervention, with results expected in 2024, marking it as the first hybrid effectiveness-implementation study of its kind in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study. O'Reilly, SL., Laws, R., Maindal, HT., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12451208/

Lifestyle‐based and psychological interventions during ... Of the studies combining diet and physical activity, eight reported reductions in gestational weight gain and two less gestational diabetes. One ...

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. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1687963/full

Systematic review on community-based interventions ... For these studies, we found a variety of outcomes. We observed a small increase (less than 5%) in the prevalence of overweight or obesity in the intervention ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1751485123000582

A Systematic Review of Women's Experiences ... In summary, women experienced several positive outcomes as a result of their engagement in interventions to prevent excessive GWG. These included social support ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806186

Key Components of Antenatal Lifestyle Interventions to ... This meta-analysis investigates the association of components of antenatal lifestyle interventions with optimized gestational weight gain ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499267106020107

Community-based Exercise and Dietary Intervention ... The preliminary data indicated that exercise and diet intervention have the potential to reduce adverse pregnancy outcomes, including excessive weight gain, GDM ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07262-3

Healthcare related barriers and enablers for weight ... This study aimed to synthesise evidence documenting healthcare-related barriers and enablers for weight management among pregnant women with overweight or ...