Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure: 38 weeks
研究概览
简要总结
The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.
详细描述
The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).
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
- Single (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
- 否
入选标准
- •(a) Body Mass Index > 30,
- •(b) singleton pregnancy,
- •(c) between 11-15 weeks of pregnancy (at enrollment),
- •(d) Do not currently meet recommended guidelines of 150 min of activity per week
- •(e) cleared by physician
排除标准
- •(a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
- •(b) illicit drug use.
结局指标
主要结局
Acceptability of Intervention Measure: 38 weeks
时间窗: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Feasibility of Intervention Measure:38 weeks
时间窗: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
次要结局
- Body Mass Index(Change from Baseline to Delivery and 6 Months Post Delivery)
- Total Cholesterol from Lipid Panel(Change from Baseline to Delivery and 6 Months Post Delivery)
- Number of intervention sessions completed(15 weeks through 38 weeks)
- Blood Pressure(Change from Baseline to Delivery and 6 Months Post Delivery)
- Number of minutes of physical activity(Change from Baseline to Delivery and 6 Months Post Delivery)