Health Interventions for Obesity During Pregnancy
(CHIME Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for pregnant individuals dealing with obesity or chronic diseases like diabetes. They should be interested in managing their weight during and after pregnancy. Participants will need to commit from early pregnancy until 12 months postpartum, completing questionnaires, dietary recalls, interviews, measurements, and blood tests.

Inclusion Criteria

I am 18 years old or older.

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)

+1 more

Exclusion Criteria

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)

Multiple gestations

+3 more

Participant Groups

The CHIME trial compares three approaches: usual care versus two multi-level interventions aimed at reducing maternal weight retention a year after giving birth. One intervention focuses on self-management while the other is community-based; both include nutrition and activity counseling.

3Treatment groups

Experimental Treatment

Active Control

Group I: Self-ManagementExperimental Treatment1 Intervention

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.

Group II: Community-BasedExperimental Treatment1 Intervention

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

Group III: Usual CareActive Control1 Intervention

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.