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CHIME: Comparing Health Interventions for Maternal Equity

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
United States
California
Stanford University
ACTIVE_NOT_RECRUITING
Palo Alto
New York
New York Presbyterian Queens
RECRUITING
Flushing
Columbia University Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Jennifer Woo Baidal Associate Professor, MD, MPH
jwoo1@stanford.edu
650-721-2250
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2030-04-01
Participants
Target number of participants: 795
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov