Mentoring to be Active for Rural Appalachia Children

NCT05758441 | Completed Results

• 2 other identifiers: GR13019611-22-ICTSN-30
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity; Exercise; Body Composition

Keywords

Physical Activity, Body Composition, Health Behavior

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline and 9 months post intervention

Secondary Outcomes (1)

• Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer

  baseline and 9 months post baseline

Other Outcomes (2)

• PROMIS Parent Proxy Physical Activity (PA)

  Baseline, 9 months post-baseline

• PROMIS Parent Proxy Global Health

  Baseline, 9 months post-baseline

Study Arms (2)

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.

Behavioral: Mentoring to be Active plus Family

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.

Behavioral: Tracking Health and Fitness

Interventions

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.

Also known as: MPBA

Mentoring to be Active plus Family (MPBA+F)

Tracking Health and Fitness BEHAVIORAL

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

Tracking Health and Fitness

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 40018636 DERIVED

MeSH Terms

Conditions

Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Laureen H. Smith, Principal Investigator
• Organization: The Ohio State University

smith.5764@osu.edu

6142924578

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained research assistants who will collect data and survey measures are blinded to study condition of each participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For this community-based study, a stratified randomized-controlled clinical trial will evaluate MPBA+F among 7/8th grade children with overweight or obesity recruited during years 1 and 2 of the study from rural Appalachian counties. Stratification by biological sex to have equal numbers of males and females will occur. Investigators will recruit 288 children to participate. Half will be randomized to receive MPBA+F; the other half will receive a comparison program of 10 weekly, self-guided modules from mailed to their home. By following participants from the start of 7th grade (baseline) through the middle of 8th grade, longer-term effects on PA outcomes and body composition can be determined. Differences in outcomes are explored by examining sub-group differences on effects. A sub-set of parents from both study conditions will be recruited (72 parents from each condition) to provide child assessments of perceived PA behaviors and perceived child health.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 7, 2023
• Study Start: March 7, 2023
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: July 7, 2026
• Results First Posted: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 months of publication or 18 months if results are not published.
• 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.

Locations

US (1)