Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06724172

CHIME: Comparing Health Interventions for Maternal Equity

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity and Overweight Body Weight Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Management

Behavioral

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.

Community-Based

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Woo Baidal Associate Professor, MD, MPH

CONTACT

[email protected]

650-721-2250

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: CHIME

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 9, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.