CHIME: Comparing Health Interventions for Maternal Equity (CHIME)

March 3, 2026 updated by: Jennifer Woo Baidal, Stanford University

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum.

The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum.

Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group.

Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention.

Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of:

  • Questionnaires
  • Dietary recalls
  • In-depth interviews
  • Anthropometric measurements
  • Collection of blood via finger stick or blood panel

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

795

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Active, not recruiting
        • Stanford University
    • New York
      • Flushing, New York, United States, 11355
        • Recruiting
        • New York Presbyterian Queens
        • Principal Investigator:
          • Daniel Skupski, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Natasha Williams, EdD, MPH
      • New York, New York, United States, 10012
        • Recruiting
        • Columbia University Medical Center
        • Principal Investigator:
          • Dympna Gallagher, EdD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Management
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.
Behavioral: Self-Management
We will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change.
Experimental: Community-Based
A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.
Behavioral: Community-Based
As is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal postpartum weight retention at 12-months postpartum.
Time Frame: From enrollment to the end of the intervention at 12 months postpartum.
The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation.
From enrollment to the end of the intervention at 12 months postpartum.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Household social needs and maternal perinatal health outcomes
Time Frame: From enrollment to the end of the intervention at 12 months postpartum.
We will obtain patient self-reported measures where applicable for secondary outcomes through validated questionnaires. Secondary outcomes include household food security, gestational weight gain, gestational diabetes, with maternal race and ethnicity and pre-pregnancy body mass index category as effect modifiers.
From enrollment to the end of the intervention at 12 months postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Patient-Centered Outcomes Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

January 15, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77034
  • 20244792 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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