CHIME: Comparing approaches to support healthy pregnancy and postpartum weight
CHIME: Comparing Health Interventions for Maternal Equity
This trial will try two different support programs versus usual care to see if they help pregnant people from early pregnancy through one year after birth keep a healthier weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 795 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Locations | 4 sites (Palo Alto, California and 3 other locations) |
| Trial ID | NCT06724172 on ClinicalTrials.gov |
What this trial studies
This randomized, multi-site trial enrolls pregnant participants at ≤20 weeks gestation and randomizes them to one of two multi-level, multi-component interventions (a self-management program or a community-based program) or to usual care. Interventions begin in early pregnancy and continue through 12 months postpartum, with five research visits that include questionnaires and weight and height measurements. The primary outcome is maternal postpartum weight retention at 12 months postpartum, comparing each intervention arm to usual care and comparing the two interventions to each other. Enrollment is targeted to people aged 18 and older who plan to continue care at the recruitment site and who meet at least one social-risk criterion such as identifying as Black/African American or Hispanic/Latino or being insured by Medicaid, with English or Spanish language ability required.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 or older with a viable singleton pregnancy at ≤20 weeks who plan to continue care at a participating site and who meet at least one social-risk criterion (Black/African American, Hispanic/Latino, Medicaid-insured, or English/Spanish speaker).
Not a fit: People under 18, those with underweight pre-pregnancy BMI (<18 kg/m2), those with medical conditions or treatments that substantially affect weight, or those not planning to continue care at the participating sites are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the interventions could reduce postpartum weight retention and improve longer-term maternal cardiometabolic health, especially for groups facing social and access barriers.
How similar studies have performed: Previous lifestyle and counseling interventions in pregnancy have shown modest improvements in gestational weight gain and postpartum weight retention, while multi-level community approaches are promising but less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age 18 years or older * Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term * Plans to continue receiving antenatal care at the recruitment site/network * Maternal characteristics include at least one of the following: * Self identifies as Black/African American * Self identifies as Hispanic/Latino/a/e/x * Insured by Medicaid * Maternal ability to speak English or Spanish * Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization) Exclusion Criteria: * Age \< 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent * 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) * Unwillingness or inability to complete study visits or intervention components * Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site * Multiple gestations
Where this trial is running
Palo Alto, California and 3 other locations
- Stanford University — Palo Alto, California, United States (Active_not_recruiting)
- New York Presbyterian Queens — Flushing, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Woo Baidal Associate Professor, MD, MPH
- Email: jwoo1@stanford.edu
- Phone: 650-721-2250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.