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临床试验/NCT05758441
NCT05758441已完成不适用

Mentoring to be Active: Peer Mentoring to Mitigate Obesity and Extreme Obesity in Rural Appalachian Children

Ohio State University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年3月7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
58
试验地点
1
主要终点
Change in Daily Physical Activity

研究概览

简要总结

The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors. Building and reinforcing skills, MPBA+F mitigates resource stressors and strengthens protective factors by providing culturally appropriate knowledge and skills to improve the sustainability of physical activity at home without the use of exercise equipment. By strengthening social support through peer and friendship networks and family-based support, MPBA+F responds to the unique needs of rural Appalachians in a culturally responsive way. This study targets physical activity among children with overweight, obesity, or extreme obesity because rural Appalachian communities identify sedentary activity as a key contributor to the high rates of obesity and diabetes risk among youth.

详细描述

Appalachians die more frequently and at younger ages from obesity-related conditions than those living elsewhere. High prevalence of overweight, obesity, and extreme obesity in Appalachian children increases the severity of diabetes. In rural Appalachia, the diabetes mortality rate is 11% higher than the national rate.Over the course of two years, this study will test the effects of the Mentored Planning to be Active + Family intervention on physical activity outcomes (MVPA, exercise "bouts", sedentary behavior) and health outcomes (body composition: BMI, body fat, % body fat, weight) among rural Appalachian 7/8th grade children suffering from overweight and obesity. Having teens deliver the content via structured peer mentoring increases social support, motivation, and self-regulation to sustain PA behaviors to improve health outcomes as children enter high school. Using local residents for intervention delivery leverages rural Appalachians' preference to receive health information via established social networks and extends delivery of the program into the community. This study is a community-based randomized controlled trial targeting 7th grade students in rural Appalachia. Half (n = 144) will receive MPBA+F; the other half (n = 144) will receive self-guided (usual care) modules. Tenth-grade (n = 73) students from the same rural Appalachian counties will serve as peer mentors delivering MPBA for the peer mentoring group. Parents will provide a family reinforcement program during 8th grade and provide assessments of child behaviors and health outcomes. The long-term goal is to reduce the high rates of OW, OB/EO and type 2 diabetes in Appalachia youth through effective, sustainable interventions. Improving self-regulation, self-efficacy, and social support to increase intentional exercise and MVPA among underserved youth suffering from early-onset OB/EO builds healthier lifestyle behaviors at a critical development time.

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)

盲法说明

Trained research assistants who will collect data and survey measures are blinded to study condition of each participant.

入排标准

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

入选标准

  • enrolled in 7th grade at the start of the study,
  • have a body mass index percentile of 85th or greater for age and gender,
  • not under medical care for OB or type 1 diabetes,
  • have reliable internet connection at home,
  • have access to a computer, laptop or tablet at home,
  • not expected to move from the participating county before the conclusion of the study.
  • read at a 5th grade-level,
  • speak English,
  • have a home-mailing address (not PO box),
  • have a working telephone number, and
  • are not expected to move from the participating county before study conclusion.
  • High school peer mentors:
  • are in either 10th or 11th grade at the start of the recruitment,
  • reside in a targeted county,
  • interested in working with peers, supporting others, and striving to cultivate their own health-supportive behaviors,
  • have reliable internet connection at home,
  • have access to a computer, laptop or tablet at home,
  • are not expected to move before the intervention ends,
  • can speak English,
  • are recommended by a teacher, school advisor, or counselor.

排除标准

  • not in 7th grade at the start of the study.
  • not able to read or Speak English;
  • not classified as either overweight or obese at start of study.
  • - not able to read or speak English.
  • High school peer mentors:
  • - cannot speak and read English.

研究组 & 干预措施

Tracking Health and Fitness

Active Comparator

Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home.

Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA.

干预措施: Tracking Health and Fitness (Behavioral)

Mentoring to be Active plus Family (MPBA+F)

Experimental

For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules.

干预措施: Mentoring to be Active plus Family (Behavioral)

结局指标

主要结局

Change in Daily Physical Activity

时间窗: 7 days- collected at baseline, at week 12 when mentoring sessions end, and at 9 months when the reinforcement program ends

Daily levels of moderate and vigorous physical activity collected by accelerometry.

Change in Daily Moderate-to-Vigorous Physical Activity (MVPA)

时间窗: baseline and 9 months post intervention

Number of minutes spent in Moderate-to-Vigorous Physical Activity (MVPA) over a 7-day period is collected by accelerometry. The total number of minutes spent in MVPA is measured at baseline and again 9 months post intervention as a sum of the MVPA minutes across a 7-day period at each time point. The change in minutes of daily Moderate-to-Vigorous Physical Activity (MVPA) from baseline to follow up was assessed.

次要结局

  • Change in Body Composition(baseline, at 12 weeks when mentoring sessions end, and at 9 months when the reinforcement program ends.)
  • Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer(baseline and 9 months post baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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