CHIME: Comparing Health Interventions for Maternal Equity

Last updated: March 3, 2026
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Neuropathy

Pregnancy

Obesity

Treatment

Self-Management

Community-Based

Clinical Study ID

NCT06724172
77034
20244792
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Maternal age 18 years or older

  • Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented onfirst 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 heightmeasurement prior to randomization)

Exclusion

Exclusion Criteria:

  • Age < 18 years at baseline because of unique developmental differences ofadolescents 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., significantgastrointestinal conditions, major psychiatric disorders, and others at thediscretion 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 Design

Total Participants: 795
Treatment Group(s): 2
Primary Treatment: Self-Management
Phase:
Study Start date:
January 22, 2026
Estimated Completion Date:
April 01, 2030

Connect with a study center

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • New York Presbyterian Queens

    Flushing, New York 11355
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10012
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • New York Presbyterian Queens

    Flushing 5117472, New York 5128638 11355
    United States

    Site Not Available

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