NCT06724172 · Stanford University
CHIME: Comparing Health Interventions for Maternal Equity
(CHIME)
What this study is 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Self-Management
We will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change.
BEHAVIORAL
Community-Based
As is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting.
Primary outcome measures
Maternal postpartum weight retention at 12-months postpartum.
Time frame: From enrollment to the end of the intervention at 12 months postpartum.
The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
- Flushing, New York
- New York, New York
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations