Maternal Health Diabetes Prevention Project Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fidelity - sessions attended
研究概览
简要总结
The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.
详细描述
In this study, investigators will pilot a 2-month Diabetes Prevention Program-like program (delivered by WIC staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive WIC services.
The goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of WIC clinics and feasibility of conducting a larger-scale study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥18 years
- •6 weeks to 12 months postpartum
- •Medical record documented diagnosis of GDM during most recent pregnancy
- •Access to a device that can access the internet
- •English speaking
排除标准
- •Pregnant or planning to become pregnant in the next two months
- •Planning to move out of the area in the next two months
- •Self-report of diagnosed diabetes
- •Use of glucose-lowering medications
- •Plasma glucose >200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c >6.5% (based on screening visit blood draw)
- •Unable or unwilling to provide informed consent
结局指标
主要结局
Fidelity - sessions attended
时间窗: 8-week intervention
Number of sessions attended throughout the 8 week intervention
次要结局
- Fidelity - sessions held(8-week intervention)
- Fidelity - session content(8-week intervention)
- Intervention feasibility(2-month data collection visit)
- Intervention appropriateness(2-month data collection visit)
- Intervention acceptability(2-month data collection visit)