Trial Outcomes & Findings for Mentoring to be Active for Rural Appalachia Children (NCT NCT05758441)
NCT ID: NCT05758441
Last Updated: 2026-07-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
baseline and 9 months post intervention
Results posted on
2026-07-07
Participant Flow
A multi-phase recruitment plan was followed. Potential participants were recruited from local institutional offices and through social media advertisements including Facebook and Instagram. Children could participate even if parents did not participate in the study.
Potential participants who completed study inclusion screening but not selected to participate were: not residing in participating counties or not classified as suffering from either overweight or obesity.
Participant milestones
| Measure |
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.
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
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
Parents of Children Assigned to Mentoring to be Active Plus Family (MPBA+F)
Parents who consented to participate in the study of children assigned to the intervention arm (MPBA+F)
|
Parents of Children Assigned to the Tracking Health and Fitness (Comparison) Group
Parents who consented to participate in study for children assigned to the Tracking Health and Fitness (comparison) group
|
Peer Mentors
High school aged peer mentors who delivered the Mentoring to be Active plus Family (MPBA +F) Intervention to the children assigned to the MPBA+F arm
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
12
|
11
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
12
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mentoring to be Active for Rural Appalachia Children
Baseline characteristics by cohort
| Measure |
Total
n=58 Participants
Total of all reporting groups
|
Mentoring to be Active Plus Family (MPBA+F)
n=12 Participants
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.
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
n=11 Participants
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
Parents of Children Assigned to MPBA+F
n=12 Participants
Parents of children assigned to MPBA+F who consented to participate in study to provide data on parent perceptions
|
Parents of Children Assigned to Tracking Health an Fitness
n=11 Participants
Parents of children assigned to Tracking Health and Fitness who consented to participate in the study to provide data on parent perceptions
|
Peer Mentors
n=12 Participants
High school aged mentors who delivered the Mentoring to be Active plus Family intervention to children assigned to the MPBA+F arm
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=6 Participants
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
23.25 years
STANDARD_DEVIATION 2.84 • n=6 Participants
|
12.5 years
STANDARD_DEVIATION .90 • n=20 Participants
|
12.36 years
STANDARD_DEVIATION .81 • n=20 Participants
|
38.7 years
STANDARD_DEVIATION 5.89 • n=40 Participants
|
37.6 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
15.38 years
STANDARD_DEVIATION 1.29 • n=9 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=6 Participants
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=6 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=6 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=6 Participants
|
10 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=6 Participants
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=6 Participants
|
12 participants
n=20 Participants
|
11 participants
n=20 Participants
|
12 participants
n=40 Participants
|
11 participants
n=5 Participants
|
12 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: baseline and 9 months post interventionNumber 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.
Outcome measures
| Measure |
Mentoring to be Active Plus Family (MPBA+F)
n=12 Participants
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.
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
n=11 Participants
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
|---|---|---|
|
Change in Daily Moderate-to-Vigorous Physical Activity (MVPA)
|
22.05 MVPA minutes per week
Standard Deviation 7.71
|
23.45 MVPA minutes per week
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: baseline and 9 months post baselineThe 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.
Outcome measures
| Measure |
Mentoring to be Active Plus Family (MPBA+F)
n=12 Participants
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.
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
n=11 Participants
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
|---|---|---|
|
Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer
|
62.5 mean percent change in body composition
Standard Deviation 8.5
|
66.7 mean percent change in body composition
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 9 months post-baselinePROMIS 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.
Outcome measures
| Measure |
Mentoring to be Active Plus Family (MPBA+F)
n=12 Participants
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.
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
n=11 Participants
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
|---|---|---|
|
PROMIS Parent Proxy Physical Activity (PA)
|
23.87 score on a scale
Standard Deviation 6.22
|
18.7 score on a scale
Standard Deviation 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 9 months post-baselinePROMIS 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.
Outcome measures
| Measure |
Mentoring to be Active Plus Family (MPBA+F)
n=12 Participants
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.
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
n=11 Participants
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.
Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home.
|
|---|---|---|
|
PROMIS Parent Proxy Global Health
|
25.91 score on a scale
Standard Deviation 4.63
|
20.3 score on a scale
Standard Deviation 3.67
|
Adverse Events
Parents of Children Assigned to Mentoring to be Active Plus Family (MPBA+F)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parents of Children Assigned to the Tracking Health and Fitness Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Mentors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mentoring to be Active Plus Family (MPBA+F)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tracking Health and Fitness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Laureen H. Smith, Principal Investigator
The Ohio State University
Phone: 6142924578
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place