CHIME: Comparing Health Interventions for Maternal Equity

Stanford University

Status: Enrolling

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

Treatments: Behavioral: Self-Management; Behavioral: Community-Based

Study type: Interventional

Funder types: Other

Identifiers

NCT06724172

77034

20244792 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 795 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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795 participants in 3 patient groups

Self-Management

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Management

Community-Based

Experimental group

Description:

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

Treatment:

Behavioral: Community-Based

Usual Care

No Intervention group

Description:

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.