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CHIME: Comparing Health Interventions for Maternal Equity

CHIME: Comparing Health Interventions for Maternal Equity

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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

Study details
    Obesity and Overweight
    Nutrition
    Chronic Disease
    Diabetes
    Pregnancy

NCT06724172

Stanford University

1 February 2026

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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