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Recruiting NCT06724172

NCT06724172 CHIME: Comparing Health Interventions for Maternal Equity

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Clinical Trial Summary
NCT ID NCT06724172
Status Recruiting
Phase
Sponsor Stanford University
Condition Obesity and Overweight
Study Type INTERVENTIONAL
Enrollment 795 participants
Start Date 2026-01-22
Primary Completion 2030-01-15

Trial Parameters

Condition Obesity and Overweight
Sponsor Stanford University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 795
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2026-01-22
Completion 2030-01-15
Interventions
Self-ManagementCommunity-Based

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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

Eligibility Criteria

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 discret

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