Mentoring to be Active for Rural Appalachia Children

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

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Exercise; Body Composition
• Intervention / Treatment: Behavioral: Mentoring to be Active plus Family; Behavioral: Tracking Health and Fitness

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mentoring to be Active plus Family (MPBA+F); 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.	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.; Other Names: MPBA
Active Comparator: Tracking Health and Fitness; 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.	Behavioral: Tracking Health and Fitness; 10 self-guided, self-paced modules mailed to child participants home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• Smith LH, Petosa RL, Tan A, Shankle S, Phosri Y. Randomised trial of Mentored 'Planning to be Active+Family' [MPBA+F] for Appalachian youth at risk for diabetes: virtual delivery protocol. BMJ Public Health. 2024 Nov 2;2(2):e000798. doi: 10.1136/bmjph-2023-000798. eCollection 2024 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity, Body Composition, Health Behavior
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Behavior
• Other Study ID Numbers: GR130196; 11-22-ICTSN-30 (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The American Diabetes Association policies and guidance for availability and sharing of research results and resources will be followed. All data that can be shared without compromising human subject protections will be shared to an approved open data repository as required. Study-related data will be anonymized, catalogued, and stored per federal guidelines and university policies. A public use, de-identified dataset will be available to qualified investigators upon request after analyses have been conducted and findings have been published. All identifiers will be removed. A request in writing, stating intended use must be submitted. Data sets will be accompanied by a data dictionary, both derived and raw data. The most cost-effective means for sharing data will be followed after a data sharing agreement has been reached. Curricular materials will be provided at no charge.
• IPD Sharing Time Frame: Within 6 months of publication or 18 months if results are not published.
• IPD Sharing Access Criteria: A written request for any study data, protocols or other materials must be sent to Principal Investigator. Once approved, materials will be made available by agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No