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临床试验/NCT02329262
NCT02329262已完成不适用

A Skills-based RCT for Physical Activity Using Peer Mentors

Ohio State University20 个研究点 分布在 1 个国家目标入组 571 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
571
试验地点
20
主要终点
Change in Body Mass Index From T1 to T3

研究概览

简要总结

This approach will train peer mentors to deliver a culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens

详细描述

The goal of this study is to positively impact the physical activity patterns to improve health outcomes including the high rates of obesity in Appalachian teens. The approach will train peer mentors to deliver the culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The primary objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens. Refined over the course of 3 studies,2-4 PBA is a ten-lesson unit delivered over 10 weeks and designed to teach self-regulation of physical activity among teens. Expanding PBA to mentors via MBA has the potential to promote and sustain adoption of daily regular physical activity through self-regulation of physical activity in discretionary time. With MBA delivery, physical activity is tailored to personal interests, talents, and neighborhood environment. MBA empowers students to plan and evaluate their own personal activity plan. It is predicted that by serving as role models, peer mentors will improve their own lifestyle behaviors, providing a double-edged intervention. It is also predicted that providing intense and structured social support to teens via peer mentors will result in better health outcomes compared to teacher-based support alone (usual care). The plan is to conduct a group randomized controlled trial to evaluate the effects of a culturally and theoretically based behavioral intervention delivered by peer mentors (MBA) on adolescent healthy behaviors (daily physical activity, regular exercise, and sedentary behaviors) and physical health outcomes (BMI, body fat) compared to PBA delivered in a classroom setting by a teacher.

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
14 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •9th or 10th grade students as participants
  • •11th or 12th grade students as mentors
  • •Classroom teachers who instruct health education or physical education to 9th and 10th grade students.
  • •Not expected to move from school prior to conclusion of study
  • •Speaks English

排除标准

  • •Peer mentors with a BMI (for age and gender) above the 85th percentile or below the 5th percentile at the start of the study

研究组 & 干预措施

Mentoring to be Active

Experimental

Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers.

干预措施: Mentoring to be Active with Accelerometers (Behavioral)

Planning to be Active

Active Comparator

High school teachers will deliver the physical activity curriculum (usual care) to high school students enrolled in health education courses. Physical activity will be measured with accelerometers.

干预措施: Planning to be Active with Accelerometers (Behavioral)

Peer Mentors

No Intervention

11 and 12 grade-level trained mentors who lead the Mentoring to be Active (MBA) experimental group as peer mentors.

High School Teachers

No Intervention

High School teachers who taught the usual care healh classes for the Planning to be Active (PBA) active comparator group.

结局指标

主要结局

Change in Body Mass Index From T1 to T3

时间窗: T1 (Baseline) to T3 (9 months-post baseline)

Body mass index is caculated as weight in kilograms divided by the square of height in meters. The measure is the change in BMI from baseline to 9 months post-baseline.

Change in Total Body Weight From T1 to T3

时间窗: T1 (baseline) to T3 (9-month post baseline)

Change in total body weight from baseline to 9 months post-baseline.

Change in Pounds of Body Fat From T1 to T3

时间窗: T1 ( Baseline) to T3 (9-months post baseline)

Body fat in pounds measured by Tanita Body Composition Analyzer. This equipment provides estimated values for each measured value of body fat percentage, fat mass, fat free mass, muscle mass and bone mass by the DXA method, estimated value for the total body water measured value by the dilution method and estimated value for the visceral fat rating by MRI method using the Bioelectrical Impedance Analysis (BIA method). The Tanita Body Composition Analyzer measures body composition using a constant current source with a high frequency current (6.25kHz, 50kHz, 90μA). The 4 electrodes are positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. Body weight measured with shoes and socks removed. Calculated to the nearest 0.2 pounds.

次要结局

  • Moderate Physical Activity (Daily)(9 months)
  • Outcome Expectancies Scale(9 months)
  • Exercise Self-Efficacy Scale(9 months)
  • Outcome Expectations Scale(9 months)
  • Social Support From Family and Friends to Exercise(9 months)
  • Vigorous Physical Activity(9 months)

研究者

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

Laureen Smith

Associate Professor

Ohio State University

研究点 (20)

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