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临床试验/NCT02400554
NCT02400554已完成不适用

Yappalli - The Road to Choctaw Health

University of Washington2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
2
主要终点
Changes in Physical Activity assessed using items from the California Health Interview Survey

研究概览

简要总结

This is an obesity and alcohol, tobacco, and other drug (ATOD) use risk prevention and health leadership program. This project will include 150 at-risk adult Native women across 5 communities (30 women from each community) in the Choctaw Nation of Oklahoma. The intervention targets individual behavioral change relative to ATOD and obesity prevention and simultaneously provides behavioral skills for health promotion leadership.

Investigators will conduct a longitudinal study using a cluster randomized stepped-wedge design to evaluate the intervention impact on ATOD and obesity prevention primary aims of: (1) substance use harm reduction and ATOD use and intentions to use; and (2) reduction in weight/body mass index (BMI) and increase in leisure-time physical activity/physical activity (LTPA/PA) and healthful food habits. Specifically, investigators will ask participants to participate in up to eight group sessions (based on a curriculum drawing on cultural teachings around health and behavioral change); attend up to three Motivational Interviewing individual sessions (to identify individual behavioral change goals); attend a two-day overnight culture and Trail prep camp; participate in camping and walking for up to 10 days on the Trail; and attend up to six post-walk meetings (to develop community health events). All five communities will also be asked to complete a baseline health assessment as well as three follow up assessments over the course of the year. Additionally, communities 2-5 will participate in three pre-intervention health assessments. This intervention integrates components of motivational interviewing, information-motivation-behavior, and a leadership development framework for adults. It targets individual behavioral change relative to ATOD and obesity prevention and simultaneously provides behavioral skills for health promotion leadership within their respective communities.The project addresses a critical public health issue among a group experiencing considerable health disparities and strengthens the research infrastructure in partnership with the Tribe. If efficacious, it has the potential for widespread dissemination and could be generalizable to other chronic co-occurring mental health and physical health conditions.

详细描述

Study Design:

Investigators will conduct a 5-community longitudinal study using a cluster randomized stepped-wedge design to evaluate the intervention impact on alcohol, tobacco, and other drug (ATOD) and obesity prevention primary aims of: (1) substance use harm reduction, overall ATOD use and intentions to use; and (2) weight/body mass index (BMI) change as well as the effect on leisure-time physical activity/physical activity (LTPA/PA), and healthful food habits among adult Choctaw women at risk for obesity and ATOD. The cluster randomized stepped-wedge design is a type of cross-over study in which clusters of women from each community cross over to the intervention arm at randomly assigned time points (one time per year, per community).

Sequence and Timing of Study Procedures:

Randomization: Investigators have created five regional communities and within each community a convenience sample will be drawn. Each site has been randomly assigned to start the intervention at a given year. Randomization occurs only to determine the year each community enters the study. Community 1 will begin the intervention immediately; communities 2-5 will complete three health assessments prior to beginning the intervention. These will occur at the same time of post-walk assessments for the community currently in the intervention (i.e. community 2 does health assessments in the same months community 1 does post-walk assessments and then begins the intervention in Year 2.)

Recruitment and Screening of Participants:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

入选标准

  • Self-identify as women
  • Be enrolled in the Choctaw Nation of Oklahoma
  • Reside in the designated county
  • Be 18 years of age or older
  • Have tried any tobacco, alcohol, or drugs OR ever felt out of control with any food in past 5 years
  • Be able to walk unassisted for at least 10 minutes

排除标准

  • Women who are actively using opioids (i.e., heroin) methamphetamines and/or abusing prescription drugs not prescribed to them (e.g., Dilaudid, Oxycontin) or alcohol dependent (5+ bottles/glasses of alcohol a day).
  • Women who exhibit serious psychiatric symptoms determined by CNO trained staff.
  • Women who have been suicidal in past 3 months, are currently pregnant, or are denied medical approval.

结局指标

主要结局

Changes in Physical Activity assessed using items from the California Health Interview Survey

时间窗: Post-Walk (month 3) and Post Intervention (month 12)

Investigators will assess changes in physical activity and leisure time activity in participants using items from the California Health Interview Survey

Change in Food Habits as assessed by the Yale Food Addiction Scale

时间窗: Post-Walk (month 3) and Post Intervention (month 12)

Yale Food Addiction Scale - continuous measure items

Weight Change

时间窗: Post-Walk (month 3) and Post Intervention (month 12)

Investigators will assess weight change for each individual

Change in Alcohol Use as assessed by the Alcohol Use Disorders Identification Test.

时间窗: Post-Walk (month 3) and Post Intervention (month 12)

Assess changes in alcohol use (frequency, amount, consequences and context) using the Alcohol Use Disorders Identification Test.

Change in Other Substance Use as assessed by the Phen-X toolkit

时间窗: Post-Walk (month 3) and Post Intervention (month 12)

Phen-X toolkit for 30-Day Use (for items that are applicable)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karina Walters

Associate Dean for Research; William P. and Ruth Gerberding Endowed University Professor

University of Washington

研究点 (2)

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