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
Qualifiers
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
Treatments tested in this trial
- Self-Management
- Community-Based
Treatment groups
795 Participants
are divided into 3 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov