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临床试验/NCT01373307
NCT01373307已完成不适用

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Nancy Schoenberg1 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,250
试验地点
1
主要终点
Change in body mass index (BMI) from baseline

研究概览

简要总结

The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed lay health advisor intervention aimed at increasing fruit and vegetable intake and physical activity among intergenerational Appalachian individuals and families.

详细描述

The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to energy balance. In the intervention phase, this group-randomized trial administers and evaluates an intergenerational, culturally appropriate energy balance intervention aimed at increasing fruit and vegetable intake and increasing physical activity among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Focusing on Appalachian children, parents, and grandparents, local lay health advisors deliver a series of group presentations, adapted from We Can! and Media Smart Youth. In addition, the project provides culturally consonant leave-behind "booster" activities, including square dances, cooking classes, and community gardens.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Age 8 years or above
  • Able to provide informed consent/assent

排除标准

  • 未提供

结局指标

主要结局

Change in body mass index (BMI) from baseline

时间窗: Assessed at approximately 4 months after baseline

Positive change (i.e., decreasing BMI when indicated, or maintaining BMI when not indicated) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

Change in self-reported physical activity from baseline

时间窗: Assessed at approximately 4 months after baseline

Amount of physical activity is measured using instruments with demonstrated reliability and validity, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing physical activity) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

Change in self-reported fruit and vegetable intake from baseline

时间窗: Assessed approximately 4 months after baseline

Amount of fruit and vegetable intake is measured using an FFQ, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing fruit and vegetable intake) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

次要结局

  • Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baseline(Assessed approximately 4 months after baseline)
  • Number of visits completed(Approximately 4 months after baseline)
  • Retention (i.e., number of participants who complete all planned assessment timepoints)(Approximately one year after baseline)

研究者

发起方
Nancy Schoenberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nancy Schoenberg

Sponsor/PI

University of Kentucky

研究点 (1)

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