Physical ActivityNCT05758441
Mentoring to be Active for Rural Appalachia Children
A study testing Mentoring to be Active plus Family and Tracking Health and Fitness in people with Physical Activity and Exercise, run by Ohio State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Exercise, Body Composition
- What is being tested?
- Mentoring to be Active plus Family and Tracking Health and Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 10 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Exercise, Body Composition
- Being tested
- Mentoring to be Active plus Family, Tracking Health and Fitness
- Keywords
- Physical Activity, Body Composition, Health Behavior
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentoring to be Active plus FamilyBehavioural
Also called MPBA
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 FitnessBehavioural
10 self-guided, self-paced modules mailed to child participants home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Tracking Health and Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 9 months post intervention
Secondary outcomes (1)
Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer
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.
Measured: baseline and 9 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start7 Mar 2023
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758441
- Sponsor's protocol ID
- GR130196
- Other IDs
- 11-22-ICTSN-30
- Status last verified
- Jun 2026
- First submitted
- 16 Feb 2023
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40018636