Mentoring to be Active for Rural Appalachia Children

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758441
• Other study ID #: GR130196
• Secondary ID: 11-22-ICTSN-30
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: November 14, 2025

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: Laureen Smith, PhD
• Phone: 614-292-4578
• Email: smith.5764[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: November 14, 2025
• Est. primary completion date: November 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition
• Exercise
• Physical Activity

Intervention

Behavioral:
• Mentoring to be Active plus Family
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.
• Tracking Health and Fitness
10 self-guided, self-paced modules mailed to child participants home.

Locations

Country	Name	City	State
United States	Ohio State University College of Nursing	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Parent Perceptions of Child's Physical Activity Behaviors	8-item PROMIS instrument measures the 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.	Baseline and at 9 months when the reinforcement program ends.
Other	Change in Parent Perceptions of Child's General Health	7-item PROMIS Global Health instrument measures parent perceptions of their child's overall general health, physical health, mental health, social health and quality of life.	Baseline and at 9 months when the reinforcement program ends.
Primary	Change in Daily Physical Activity	Daily levels of moderate and vigorous physical activity collected by accelerometry.	7 days- collected at baseline, at week 12 when mentoring sessions end, and at 9 months when the reinforcement program ends
Secondary	Change in Body Composition	Anthropometric (body composition- raw weight, BMI, body fat) using the Tanita 430-DCU Body Composition Analyzer	baseline, at 12 weeks when mentoring sessions end, and at 9 months when the reinforcement program ends.