CHIME: Comparing Health Interventions for Maternal Equity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 795
- 试验地点
- 4
- 主要终点
- Maternal postpartum weight retention at 12-months postpartum.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Self-Management
A self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care.
干预措施: Self-Management (Behavioral)
Community-Based
A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.
干预措施: Community-Based (Behavioral)
Usual Care
Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling.
结局指标
主要结局
Maternal postpartum weight retention at 12-months postpartum.
时间窗: 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.
次要结局
- Household social needs and maternal perinatal health outcomes(From enrollment to the end of the intervention at 12 months postpartum.)
研究者
Jennifer Woo Baidal
Associate Professor
Stanford University