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临床试验/NCT04253977
NCT04253977招募中2 期

Promoting Healthy Weight Across the Pregnancy and Postpartum Period Through Dissemination of an Evidence Based Intervention

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 784 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
784
试验地点
2
主要终点
Change in weight

研究概览

简要总结

This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.

详细描述

Women are exceptionally vulnerable during childbearing years to gain disproportionally large amounts of weight when compared to men or other life periods. Weight gained during pregnancy and retained after the postpartum period contributes to obesity development and progression. Evidence based lifestyle interventions addressing the trajectory of weight gain across the childbearing continuum can reverse these alarming trends of excessive weight among young women, but have had limited uptake due to time, expense, and parenting priorities. To address this gap, our research team developed the lifestyle intervention Healthy Eating, Activity Living, Taught at Home during Pregnancy and Postpartum (HEALTH-P2) in partnership with Parents as Teachers (PAT). This study will provide evidence for the dissemination and implementation (D&I) of HEALTH-P2 across PAT's network of sites, promoting healthy weight on a national scale. The study builds on our previous work with a pragmatic cluster randomized controlled trial to evaluate D&I of HEALTH-P2 across multiple levels to achieve widespread impact. First, we will determine weight outcomes (12-month postpartum weight; gestational weigh gain) among 336 overweight/obese women (N=168 HEALTH-P2; N=168 usual care) when parent educators (~8/site) from PAT sites nationwide receive the HEALTH-P2 training through PAT National Center's existing training infrastructure and conduct HEALTH-P2 as part of routine practice. From a D&I perspective, an evaluation guided by RE-AIM will measure implementation outcomes (acceptability, appropriateness, feasibility, fidelity, adaptation). Further, the Conceptual Framework for Implementation Research will guide an assessment of contextual factors that influence external validity at multiple levels (mother, parent educator, PAT site).

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Deliver PAT at a site participating in the study
  • Provide informed consent

排除标准

  • At least 18 years of age
  • For the participants:
  • Inclusion Criteria:
  • 18-45 years of age
  • overweight or obese (BMI over 25 kg/m2) before becoming pregnant
  • English or Spanish speaking
  • participating or willing to participate in PAT at a participating PAT site until baby turns 1
  • able to give informed consent for participation
  • Exclusion Criteria:
  • planning to become pregnant again before their baby turns 1
  • unable to engage in a walking program

结局指标

主要结局

Change in weight

时间窗: 12 months postpartum

Mother's body weight

次要结局

  • Fidelity of delivery to the intervention(throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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