CHIME: Comparing Health Interventions for Maternal Equity

NCT06724172 | Recruiting DMC

• 2 other identifiers: 7703420244792
• Study Type: interventional
• Target: 795
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Nutrition; Chronic Disease; Diabetes; Pregnancy; Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Maternal postpartum weight retention 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 Outcomes (1)

• Household social needs and maternal perinatal health outcomes

  From enrollment to the end of the intervention at 12 months postpartum.

Study Arms (3)

Self-Management

EXPERIMENTAL

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

Community-Based

EXPERIMENTAL

A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.

Behavioral: Community-Based

Usual Care

NO INTERVENTION

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.

Interventions

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.

Self-Management

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.

Community-Based

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

ACTIVE NOT RECRUITING

New York Presbyterian Queens

Flushing, New York, 11355, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10012, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Chronic Disease; Diabetes Mellitus

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jennifer Woo Baidal Associate Professor, MD, MPH

CONTACT

650-721-2250; jwoo1@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 22, 2026
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)