Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 722
- 试验地点
- 2
- 主要终点
- Difference in uptake (primary implementation outcome)
研究概览
简要总结
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
详细描述
The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).
Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the cluster design and intervention program, the study participants, health coaches, DPP Coordinators, WIC clinic staff, and research staff who collect clinical outcome data will not be blinded.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in uptake (primary implementation outcome)
时间窗: Measured from baseline to 12 months
The primary implementation outcome will be the difference between study arms in a composite uptake score, as defined by a composite score consisting of the percent of sessions attended and the percentage of times in which participants record weight, activity, and diet compared to what is recommended by the intervention.
Difference in mean 12-month weight reduction (primary health-related outcome)
时间窗: Measured at 3, 6, 9 and 12 months
The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms
次要结局
- Penetrance (WIC DPP coordinators)(12 months)
- Fidelity(12 months)
- Adoption (WIC clinics)(Baseline)
- Penetrance (WIC health coaches)(12 months)
- Acceptability(Measured at baseline, 6, and 12 months)
- Appropriateness(baseline)
- Feasibility (suitability)(Baseline)
- Adoption (WIC nutritionists)(Baseline)
- Adoption (WIC health educators)(Baseline)
- Penetrance (participants)(12 months)
- Percentage of participants who were either eligible, screened, or contacted who were enrolled.(Baseline)
- Difference in mean 12-month change in systolic blood pressure(Measured from baseline to 12 months)
- Difference in proportion of participants meeting intervention goals at 12 months(Measured from baseline to 12 months)
- Cost-effectiveness(12 months)
- Difference in mean 12-month change in percent weight reduction(Measured from baseline to 12 months)
- Difference in mean 12-month change in physical activity(Measured from baseline to 12 months)
- Difference in mean 12-month change in healthy eating index(Measured from baseline to 12 months)
- Difference in mean 12-month change in waist circumference(Measured from baseline to 12 months)
- Difference in mean 12-month change in hemoglobin A1c(Measured from baseline to 12 months)
- Difference in mean 12-month change in diastolic blood pressure(Measured from baseline to 12 months)
- Difference in mean 12-month change in health-related quality of life (HRQoL)(Measured from baseline to 12 months)