An interventional study of Mentoring to be Active with Accelerometers and Planning to be Active with Accelerometers in Health Behavior, Obesity and Motor Activity, sponsored by Ohio State University. Completed at 20 sites in United States. Open to participants aged 14 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
This approach will train peer mentors to deliver a culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens
The goal of this study is to positively impact the physical activity patterns to improve health outcomes including the high rates of obesity in Appalachian teens. The approach will train peer mentors to deliver the culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The primary objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens. Refined over the course of 3 studies,2-4 PBA is a ten-lesson unit delivered over 10 weeks and designed to teach self-regulation of physical activity among teens. Expanding PBA to mentors via MBA has the potential to promote and sustain adoption of daily regular physical activity through self-regulation of physical activity in discretionary time. With MBA delivery, physical activity is tailored to personal interests, talents, and neighborhood environment. MBA empowers students to plan and evaluate their own personal activity plan. It is predicted that by serving as role models, peer mentors will improve their own lifestyle behaviors, providing a double-edged intervention. It is also predicted that providing intense and structured social support to teens via peer mentors will result in better health outcomes compared to teacher-based support alone (usual care). The plan is to conduct a group randomized controlled trial to evaluate the effects of a culturally and theoretically based behavioral intervention delivered by peer mentors (MBA) on adolescent healthy behaviors (daily physical activity, regular exercise, and sedentary behaviors) and physical health outcomes (BMI, body fat) compared to PBA delivered in a classroom setting by a teacher.
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Exclusion Criteria:
Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers.
Behavioral: Mentoring to be Active with Accelerometers
High school teachers will deliver the physical activity curriculum (usual care) to high school students enrolled in health education courses. Physical activity will be measured with accelerometers.
Behavioral: Planning to be Active with Accelerometers
11 and 12 grade-level trained mentors who lead the Mentoring to be Active (MBA) experimental group as peer mentors.
High School teachers who taught the usual care healh classes for the Planning to be Active (PBA) active comparator group.
Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
Also known as: peer mentoring
Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Also known as: Teacher PBA
Change in Body Mass Index From T1 to T3
Body mass index is caculated as weight in kilograms divided by the square of height in meters. The measure is the change in BMI from baseline to 9 months post-baseline.
Time frame: T1 (Baseline) to T3 (9 months-post baseline)
Change in Total Body Weight From T1 to T3
Change in total body weight from baseline to 9 months post-baseline.
Time frame: T1 (baseline) to T3 (9-month post baseline)
Change in Pounds of Body Fat From T1 to T3
Body fat in pounds measured by Tanita Body Composition Analyzer. This equipment provides estimated values for each measured value of body fat percentage, fat mass, fat free mass, muscle mass and bone mass by the DXA method, estimated value for the total body water measured value by the dilution method and estimated value for the visceral fat rating by MRI method using the Bioelectrical Impedance Analysis (BIA method). The Tanita Body Composition Analyzer measures body composition using a constant current source with a high frequency current (6.25kHz, 50kHz, 90μA). The 4 electrodes are positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. Body weight measured with shoes and socks removed. Calculated to the nearest 0.2 pounds.
Time frame: T1 ( Baseline) to T3 (9-months post baseline)
Moderate Physical Activity (Daily)
Percentage of participants engaging in daily moderate physical activity. Measured by accelerometers; subjects to wear devices for 7 days at each data collection time point
Time frame: 9 months
Outcome Expectancies Scale
21 item, 6 -point Likert Summative Scale focusing on psychological determinants of physical activity. Higher values indicate higher (more positive) outcome expectancies. Range of scores are from 21-126 with a score of 63 or higher indicating more positive expectancy from engaging in physical activity.
Time frame: 9 months
Exercise Self-Efficacy Scale
14 item scale that asks participants to rank their own confidence in performing an exercise behavior from 0% confidence to 100 % confidence. Higher percentages indicate higher levels of self-efficacy to engage in physical activity. Each item may range from 0% to 100%. An item score of 51% indicates "positive" confidence. Eight or more items with at least 51% for each indicates overall" positive self-efficacy" to engage in exercise. The total scale may range from 0 (no confidence)-1400 (100% confidence on each item). A score of 408 or higher (at least 51% on a minimum of 8/14 items) indicates "positive" self-efficacy to engage in exercise.
Time frame: 9 months
Outcome Expectations Scale
40 item, 6-point Likert type scale that asks participants to rank their expectations of what physical activity will do their own health outcomes. Scores range from 40-240. Scores of 101 or above indicate more positive expectation of what physical activity can do to health outcomes (more positive health outcomes expected)
Time frame: 9 months
Social Support From Family and Friends to Exercise
12 item, 5 point Likert measure asking participants to rate each question twice: Once for family members and once for friends. Questions ask about the perceived social support to engage in physical activity within the past 3 months. Higher values indicate more social support to engage in physical activity. Values range from 12-60 for the Family Social Support and 12-60 for Friends Social Support. A total social support score is created by summing the scores for family and friends combined. A total score of 25 or above for indicates higher or more positive social support.
Time frame: 9 months
Vigorous Physical Activity
Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers.
Time frame: 9 months
Sessions Attended
Average number of sessions attended by participants
Time frame: 3 months
students attending the same school are expected to socialize together; thus, a Group-Randomized Control Trial (G-RCT) is necessary to avoid the risk of cross-contamination.There were 20 high schools recruited in 3 waves, with 4 in Wave 1, 8 in Wave 2, and 8 in Wave 3, for a total of schools. For each wave of schools, half of the schools were randomly assigned to each condition-intervention \[MBA\] and comparison \[PBA\]-for a total of 10 schools in each of the two conditions by study's end.
| Milestone | Mentoring to be Active (MBA) | Planning to be Active (Usual Care) |
|---|---|---|
| Started | 318 | 253 |
| Student participants | 252 | 248 |
| Peer mentors | 66 | 0 |
| Teachers | 0 | 5 |
| Completed | 318 | 253 |
| Not completed | 0 | 0 |
Body mass index is caculated as weight in kilograms divided by the square of height in meters. The measure is the change in BMI from baseline to 9 months post-baseline.
| kg/m2 | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Change in Body Mass Index From T1 to T3 | -.9257 ± 1.76 | -.6503 ± 2.09 |
Change in total body weight from baseline to 9 months post-baseline.
| pounds | Planning to be Active | Mentoring to be Active |
|---|---|---|
| Change in Total Body Weight From T1 to T3 | -4.96 ± 11.38 | 8.72 ± 10.94 |
Body fat in pounds measured by Tanita Body Composition Analyzer. This equipment provides estimated values for each measured value of body fat percentage, fat mass, fat free mass, muscle mass and bone mass by the DXA method, estimated value for the total body water measured value by the dilution method and estimated value for the visceral fat rating by MRI method using the Bioelectrical Impedance Analysis (BIA method). The Tanita Body Composition Analyzer measures body composition using a constant current source with a high frequency current (6.25kHz, 50kHz, 90μA). The 4 electrodes are positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. Body weight measured with shoes and socks removed. Calculated to the nearest 0.2 pounds.
| pounds | Planning to be Active | Mentoring to be Active |
|---|---|---|
| Change in Pounds of Body Fat From T1 to T3 | -3.05 ± 11.46 | -3.13 ± 12.44 |
Percentage of participants engaging in daily moderate physical activity. Measured by accelerometers; subjects to wear devices for 7 days at each data collection time point
| percentage of participants | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Moderate Physical Activity (Daily) | 4.9 | 4.9 |
21 item, 6 -point Likert Summative Scale focusing on psychological determinants of physical activity. Higher values indicate higher (more positive) outcome expectancies. Range of scores are from 21-126 with a score of 63 or higher indicating more positive expectancy from engaging in physical activity.
| score on a scale | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Outcome Expectancies Scale | 81.47 ± 13.6 | 81.8 ± 13.4 |
14 item scale that asks participants to rank their own confidence in performing an exercise behavior from 0% confidence to 100 % confidence. Higher percentages indicate higher levels of self-efficacy to engage in physical activity. Each item may range from 0% to 100%. An item score of 51% indicates "positive" confidence. Eight or more items with at least 51% for each indicates overall" positive self-efficacy" to engage in exercise. The total scale may range from 0 (no confidence)-1400 (100% confidence on each item). A score of 408 or higher (at least 51% on a minimum of 8/14 items) indicates "positive" self-efficacy to engage in exercise.
| score on a scale | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Exercise Self-Efficacy Scale | 783 ± 304 | 830 ± 315 |
40 item, 6-point Likert type scale that asks participants to rank their expectations of what physical activity will do their own health outcomes. Scores range from 40-240. Scores of 101 or above indicate more positive expectation of what physical activity can do to health outcomes (more positive health outcomes expected)
| score on a scale | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Outcome Expectations Scale | 68.5 ± 12.9 | 70.3 ± 13.8 |
12 item, 5 point Likert measure asking participants to rate each question twice: Once for family members and once for friends. Questions ask about the perceived social support to engage in physical activity within the past 3 months. Higher values indicate more social support to engage in physical activity. Values range from 12-60 for the Family Social Support and 12-60 for Friends Social Support. A total social support score is created by summing the scores for family and friends combined. A total score of 25 or above for indicates higher or more positive social support.
| score on a scale | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Social Support From Family and Friends to Exercise | 29.4 ± 13.3 | 33.2 ± 13.9 |
Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers.
| Participants | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Vigorous Physical Activity | 176 | 198 |
Average number of sessions attended by participants
| sessions | Mentoring to be Active | Planning to be Active |
|---|---|---|
| Sessions Attended | 6.98 ± 3.2 | 9.6 ± 1.1 |
Participants will be asked to describe the ease of using the intervention curriculum and comparison program. General satisfaction with the program was assessed. For this 3-item, Likert summative scale, minimum scores were 3 and maximum scores were 15. Each item was scored as: 1= strongly disagree, 2= disagree, 3= neither agree or disagree, 4= agree, and 5 = strongly disagree. Participants responded to these questions: "Lessons were easy to understand.", "Lessons were clearly explained", and "Lessons met the program goals." Higher values indicated more program satisfaction.
| summative score on a 3-item scale | Planning to be Active | Mentoring to be Active |
|---|---|---|
| Ease of Use | 9.92 ± 1.57 | 12.85 ± 1.12 |
Collected over Adverse event data collected during the study timeframe, from baseline through the 9-month post-baseline follow-up period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mentoring to be Active | 0/252 (0%) | 0/252 (0%) | 0/252 (0%) |
| Planning to be Active | 0/248 (0%) | 0/248 (0%) | 0/248 (0%) |
| Peer Mentors | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| High School Teachers | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
The participant population is consistent with the overall population demographics of the counties that the schools are located in.
| Age, Categorical(Participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| <=18 years | 252 | 248 | 66 | 0 | 566 |
| Between 18 and 65 years | 0 | 0 | 0 | 5 | 5 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| Mean | 14.84 (13 to 16) | 15.25 (13 to 16) | 16.49 (15 to 17) | 38.38 (32 to 44) | 14.97 (13 to 16) |
| Sex/Gender, Customized(Participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| Male | 122 | 122 | 27 | 3 | 274 |
| Female | 130 | 126 | 39 | 2 | 297 |
| Ethnicity (NIH/OMB)(Participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 3 | 0 | 5 |
| Not Hispanic or Latino | 251 | 247 | 63 | 4 | 565 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 15 | 11 | 0 | 0 | 26 |
| Asian | 5 | 1 | 2 | 0 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 13 | 4 | 1 | 28 |
| White | 222 | 219 | 56 | 3 | 500 |
| More than one race | 0 | 4 | 0 | 0 | 4 |
| Unknown or Not Reported | 0 | 0 | 4 | 1 | 5 |
| Region of Enrollment(participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| United States | 252 | 248 | 66 | 5 | 627 |
| Grade level at beginning of study(Participants) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| 9th grade | 252 | 248 | 0 | 0 | 500 |
| 10th grade | 0 | 0 | 2 | 0 | 2 |
| 11th-12th gradee | 0 | 0 | 64 | 0 | 64 |
| N/A | 0 | 0 | 0 | 5 | 5 |
| Average Number of Household Members(number of household members) | Mentoring to be Active | Planning to be Active | Peer Mentors | High School Teachers | Total |
|---|---|---|---|---|---|
| Mean | 4.3 ± 3.9 | 4.6 ± 3.5 | 4.5 ± 3.2 | 5.2 ± 2.8 | 4.4 ± 3.3 |
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Ohio State University