Clinical trial NCT06724172: CHIME: Comparing Health Interventions for Maternal Equity
Official title: CHIME: Comparing Health Interventions for Maternal Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Nutrition
Chronic Disease
Diabetes
Pregnancy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-09
Enrollment: 795
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Maternal postpartum weight retention at 12-months postpartum.
timeFrame: From enrollment to the end of the intervention at 12 months postpartum.
Secondary outcomes:
measure: Household social needs and maternal perinatal health outcomes
timeFrame: From enrollment to the end of the intervention at 12 months postpartum.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: