CHIME: Comparing Health Interventions for Maternal Equity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-Management, Community-Based.
- Who it may be relevant to
- Registry conditions: Obesity and Overweight, Nutrition, Chronic Disease, Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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 worker
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.]
Secondary outcome measures (1)
- Household social needs and maternal perinatal health outcomes [Time frame: From enrollment to the end of the intervention at 12 months postpartum.]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Stanford University — Palo Alto
- New York Presbyterian Queens — Flushing
- Columbia University Medical Center — New York
- NYU Langone Health — New York
Identifiers
NCT: NCT06724172 · 77034 · 20244792