CHIME: Comparing Health Interventions for Maternal Equity

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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

Key Dates

Start date

Jan 22, 2026

Status verified

Mar 2026

Primary completion

Jan 15, 2030

Completion

Apr 1, 2030

Study Design

Enrollment

795 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Experimental: Community-Based
  A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.
• 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.

Primary Outcome Measure

Maternal postpartum weight retention at 12-months postpartum. [ Time Frame: From enrollment to the end of the intervention at 12 months postpartum. ]

Central Contacts

• Jennifer Woo Baidal Associate Professor, MD, MPH
  650-721-2250
  [email protected]

Locations (4)

Find similar trials in Palo Alto, CA

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