CHIME: Comparing Health Interventions for Maternal Equity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University
About 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 accepts healthy volunteersQualifiers
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
Self identifies as Black/African American
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Management
BehavioralWe 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.
Community-Based
BehavioralAs 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.
Treatment groups
795 Participants
are divided into 3 treatment groupsGroup A: Self-ManagementExperimental treatment 1 intervention
Group B: Community-BasedExperimental treatment 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maternal postpartum weight retention 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.
Time frame
From enrollment to the end of the intervention at 12 months postpartum.Secondary outcomes
1
Household social needs and maternal perinatal health outcomes
We will obtain patient self-reported measures where applicable for secondary outcomes through validated questionnaires. Secondary outcomes include household food security, gestational weight gain, gestational diabetes, with maternal race and ethnicity and pre-pregnancy body mass index category as effect modifiers.
Time frame
From enrollment to the end of the intervention at 12 months postpartum.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov