CHIME: Comparing approaches to support healthy pregnancy and postpartum weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Stanford University
  Palo Alto, California, United States Active not recruiting

Study contacts

• Study coordinator: Jennifer Woo Baidal Associate Professor, MD, MPH
• Email: jwoo1@stanford.edu
• Phone: 650-721-2250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.