Health Interventions for Obesity During Pregnancy
(CHIME Trial)
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.12345Why 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.14567Are 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants engage in one of the study interventions from early pregnancy until 12 months postpartum, including nutrition and physical activity counseling
Follow-up
Participants are monitored for maternal postpartum weight retention and other health outcomes
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?
3
Treatment groups
Experimental Treatment
Active Control
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.
A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Published Research Related to This Trial
Citations
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 ...
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.
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 ...
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 ...
Key Components of Antenatal Lifestyle Interventions to ...
This meta-analysis investigates the association of components of antenatal lifestyle interventions with optimized gestational weight gain ...
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/s12884-025-07262-3Healthcare 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.