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Completed

NCT Number: NCT05758441

Mentoring to be Active for Rural Appalachia Children

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.

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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children:

  • 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.

Parents:

  • 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.

Exclusion criteria

Child:

  • 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.

Parents :

  • not able to read or speak English.

High school peer mentors:

  • cannot speak and read English.

Treatment and study plan

Mentoring to be Active plus Family

Behavioral

Ten, structured peer mentoring sessions (once a week) covering new content each week and guided skill-building and practice. The MPBA sessions target increasing daily physical activity and replacing sugary drinks with water for hydration. Mentoring sessions are conducted virtually. A 6-month family reinforcement program follows with a reinforcement packet sent to child participants' homes once a month.

Other names: MPBA

Tracking Health and Fitness

Behavioral

10 self-guided, self-paced modules mailed to child participants home.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer

    Time frame: baseline and 9 months post baseline

    The Tanita 430-DCU Body Composition Analyzer is an FDA-cleared, dual-frequency bioelectrical impedance analysis (BIA) monitor that was used to measure anthropometric body composition through 3 measures (raw weight, body fat mass, body mass index).

    The total body composition scores were measured and compared for changes at each time point to determine the percentage of change in body composition. Lower scores indicate better outcomes. There is not a total score range available due to possible individual variability in body composition.

Other outcomes

  1. PROMIS Parent Proxy Physical Activity (PA)

    Time frame: Baseline, 9 months post-baseline

    PROMIS Parent Proxy Physical Activity (PA) is an 8-item instrument that measures a parent's perceptions of their child's performance of physical activity over the past 7 days. Physical actions reflect the levels of bodily movement ranging from simple static behaviors with minimal muscle activity to more complex activities requiring dynamic or sustained muscle activity and greater movement of the body. Each question has a range of values of 1-5, with a Raw Score total possible range of 8-40. Higher scores indicate better outcomes.

    The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported.

  2. PROMIS Parent Proxy Global Health

    Time frame: Baseline, 9 months post-baseline

    PROMIS Parent Proxy Global Health is a 7-item instrument that measures parent perceptions of their child's overall general health, physical health, mental health, social health and quality of life. Each question uses a 5-point likert scale ranging from 1-5, with a total possible score range of 7-35. Higher scores represent better health.

    The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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