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临床试验/NCT05818384
NCT05818384招募中不适用

Wakaya: Rising Up for Choctaw Youth Health

University of Washington4 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2023年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
176
试验地点
4
主要终点
Change in physical activity assessed by self-report

研究概览

简要总结

Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.

详细描述

Study participants will be recruited in staggered cohorts with those in each recruitment wave receiving individual-level random assignment to either immediate intervention or waitlist control (3 months wait to intervention) for a total of 176 Choctaw youth (ages 12-19 years) participating over 5 years.

Recruitment strategies:

The following Recruitment strategies will be used: posting flyers, posters and brochures in stores, community centers, and other locations identified by our community advisors; and posting flyers in the tribal newspaper, school newsletters, tribal gathering areas, tribal health fairs, pow wows, local boys and girls clubs, youth centers, other local news outlets, and on a study webpage.

Screening:

  • Participants will mainly be screened in-person, some may be screened over phone using the same talking points.
  • Youth who are screened out will be given a community resource list.
  • If a person is eligible, but declines to participate, they will be given a brief one-item exit question regarding general reason for non-participation.
  • Eligible youth who agree to participate will be asked to schedule their baseline assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be enrolled in Choctaw Nation of Oklahoma (CNO)
  • Live within CNO tribal region for 12 months
  • YES to one of the following:
  • Consumed sweetened beverages or processed/fast food 2x or more per week; OR
  • Engaged in excessive sitting or lying around (>540 min/day) or engage in small screen recreation (>2 hours/day); OR
  • Physical activity - spend <60 minutes/day outdoors or <2.5 hrs per week in moderate or vigorous physical activity OR spend <60 minutes a day in moderate or vigorous intensity aerobic activity; OR
  • Engage in any T.V., small screen/video game recreation (> 2 hours/day)

排除标准

  • opioid/methamphetamine drug use (2 times or more in past month)
  • allergic reactions to food (e.g. peanuts), plant (poison oak or ivy) or insects (e.g. bees, fire ants) that caused difficulty in breathing or necessitated hospitalization or caused an anaphylactic reaction
  • disability that prevents student from walking or from engaging in exercise
  • aggressive, violent, combative or inappropriate behaviors
  • inability to follow directions
  • psychotic symptoms

研究组 & 干预措施

Wait List Control

Experimental

Participants in the Wait List group will be randomly assigned to start the intervention 3 months later in the Summer.

干预措施: Wakaya: Rising Up for Choctaw Youth Curriculum (Behavioral)

Wakaya (Immediate Group)

Experimental

Participants in the immediate group will be randomly assigned to start the intervention immediately in the Spring.

干预措施: Wakaya: Rising Up for Choctaw Youth Curriculum (Behavioral)

结局指标

主要结局

Change in physical activity assessed by self-report

时间窗: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); and 6 months post-intervention (month 9)

Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ) for youth and young adults. Results can be reported in categories (low, moderate or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

Change in food and beverage habits over time

时间窗: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.

Change in physical activity intensity associated with movement, measured by accelerometer

时间窗: Baseline and 6 months post-intervention (month 9)

An actigraph accelerometer measures vertical acceleration in counts per minute. It will be worn for 7 days. Mean counts per minute are calculated by dividing the sum of activity counts for a valid day be the number of minutes of wear time in a day for all valid days. Greater number of counts per minute indicates higher physical activity intensity. Change in mean counts per minute from baseline at 9 months will be assessed.

Change in beverage habits over time

时间窗: Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

Assessed by the Modified Healthy Home Survey (2005- Beverages). It assesses the number of sweetened drinks consumed per week.

Change in sedentary behaviors over time

时间窗: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth

次要结局

  • Change in tobacco use frequency (non-ceremonial use) assessed by self-report(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Change in food addiction(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Change in alcohol use over time(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Change in marijuana use over time(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Body Mass Index (BMI) change(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Weight change assessed via digital scale(Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9))
  • Change in drug and alcohol refusal self-efficacy(Baseline; Immediate post-intervention (month 3) 3 months post (month 6); 6 months post-intervention (month 9))

研究者

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

Michelle Johnson-Jennings

Professor, School of Social Work

University of Washington

研究点 (4)

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