Trial Outcomes & Findings for A Skills-based RCT for Physical Activity Using Peer Mentors (NCT NCT02329262)

NCT ID: NCT02329262

Last Updated: 2025-03-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 571 participants
• Primary outcome timeframe: T1 (Baseline) to T3 (9 months-post baseline)
• Results posted on: 2025-03-05

Participant Flow

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.

Unit of analysis: schools

Participant milestones

Measure	Mentoring to be Active (MBA) Trained teen mentors delivered the physical activity curriculum to younger high school students in a school setting. Physical activity was measured with accelerometers. Data not collected from peer mentors. Mentoring to be Active with Accelerometers: Trained high school mentors delivered a 10-session curriculum targeting physical activity to younger teens.	Planning to be Active (Usual Care) High school teachers delivered the physical activity curriculum (usual care) to high school students enrolled in health education courses. Physical activity was measured with accelerometers. Planning to be Active with Accelerometers: Health education teachers will delivered the 10-session curriculum targeting physical activity to high school students enrolled in health courses.
Overall Study STARTED	318 10	253 10
Overall Study Student Participants	252 10	248 10
Overall Study Peer Mentors	66 0	0 0
Overall Study Teachers	0 0	5 0
Overall Study COMPLETED	318 10	253 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Skills-based RCT for Physical Activity Using Peer Mentors

Baseline characteristics by cohort

Measure	Mentoring to be Active n=252 Participants Trained teen mentors will deliver the 10- session physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers.	Planning to be Active n=248 Participants High school teachers will deliver the 10- session physical activity curriculum (usual care) to high school students enrolled in health education courses. Physical activity will be measured with accelerometers.	Peer Mentors n=66 Participants 11th and 12th grade level trained mentors who lead the Mentoring to be Active (MBA) as intervention specialists	High School Teachers n=5 Participants High School teachers who taught the usual care health classes.	Total n=571 Participants Total of all reporting groups
Age, Categorical <=18 years	252 Participants n=5 Participants	248 Participants n=7 Participants	66 Participants n=5 Participants	0 Participants n=4 Participants	566 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	14.84 years n=5 Participants	15.25 years n=7 Participants	16.49 years n=5 Participants	38.38 years n=4 Participants	14.97 years n=21 Participants
Sex/Gender, Customized Male	122 Participants n=5 Participants	122 Participants n=7 Participants	27 Participants n=5 Participants	3 Participants n=4 Participants	274 Participants n=21 Participants
Sex/Gender, Customized Female	130 Participants n=5 Participants	126 Participants n=7 Participants	39 Participants n=5 Participants	2 Participants n=4 Participants	297 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	251 Participants n=5 Participants	247 Participants n=7 Participants	63 Participants n=5 Participants	4 Participants n=4 Participants	565 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	15 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) White	222 Participants n=5 Participants	219 Participants n=7 Participants	56 Participants n=5 Participants	3 Participants n=4 Participants	500 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	252 participants n=5 Participants	248 participants n=7 Participants	66 participants n=5 Participants	5 participants n=4 Participants	627 participants n=21 Participants
Grade level at beginning of study 9th grade	252 Participants n=5 Participants	248 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	500 Participants n=21 Participants
Grade level at beginning of study 10th grade	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Grade level at beginning of study 11th-12th gradee	0 Participants n=5 Participants	0 Participants n=7 Participants	64 Participants n=5 Participants	0 Participants n=4 Participants	64 Participants n=21 Participants
Grade level at beginning of study N/A	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants
Average Number of Household Members	4.3 number of household members STANDARD_DEVIATION 3.9 • n=5 Participants	4.6 number of household members STANDARD_DEVIATION 3.5 • n=7 Participants	4.5 number of household members STANDARD_DEVIATION 3.2 • n=5 Participants	5.2 number of household members STANDARD_DEVIATION 2.8 • n=4 Participants	4.4 number of household members STANDARD_DEVIATION 3.3 • n=21 Participants

PRIMARY outcome

Timeframe: T1 (Baseline) to T3 (9 months-post baseline)

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.

Outcome measures

Measure	Mentoring to be Active n=252 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=248 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Change in Body Mass Index From T1 to T3	-.9257 kg/m2 Standard Deviation 1.76	-.6503 kg/m2 Standard Deviation 2.09

PRIMARY outcome

Timeframe: T1 (baseline) to T3 (9-month post baseline)

Change in total body weight from baseline to 9 months post-baseline.

Outcome measures

Measure	Mentoring to be Active n=248 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=252 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Change in Total Body Weight From T1 to T3	-4.96 pounds Standard Deviation 11.38	8.72 pounds Standard Deviation 10.94

PRIMARY outcome

Timeframe: T1 ( Baseline) to T3 (9-months post baseline)

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.

Outcome measures

Measure	Mentoring to be Active n=248 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=252 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Change in Pounds of Body Fat From T1 to T3	-3.05 pounds Standard Deviation 11.46	-3.13 pounds Standard Deviation 12.44

SECONDARY outcome

Timeframe: 9 months

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

Outcome measures

Measure	Mentoring to be Active n=252 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=248 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Moderate Physical Activity (Daily)	4.9 percentage of participants	4.9 percentage of participants

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Measure	Mentoring to be Active n=177 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=158 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Outcome Expectancies Scale	81.47 score on a scale Standard Deviation 13.6	81.8 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Measure	Mentoring to be Active n=183 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=172 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Exercise Self-Efficacy Scale	783 score on a scale Standard Deviation 304	830 score on a scale Standard Deviation 315

SECONDARY outcome

Timeframe: 9 months

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)

Outcome measures

Measure	Mentoring to be Active n=175 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=167 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Outcome Expectations Scale	68.5 score on a scale Standard Deviation 12.9	70.3 score on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Measure	Mentoring to be Active n=178 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=163 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Social Support From Family and Friends to Exercise	29.4 score on a scale Standard Deviation 13.3	33.2 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: 9 months

Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers.

Outcome measures

Measure	Mentoring to be Active n=252 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=248 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Vigorous Physical Activity	176 Participants	198 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Average number of sessions attended by participants

Outcome measures

Measure	Mentoring to be Active n=251 Participants Trained teen mentors will deliver the physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. Mentoring to be Active with Accelerometers: Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.	Planning to be Active n=78 Participants 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. Planning to be Active with Accelerometers: Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Sessions Attended	6.98 sessions Standard Deviation 3.2	9.6 sessions Standard Deviation 1.1

POST_HOC outcome

Timeframe: 3 months

Participants will be asked to describe the ease of using the intervention curriculum and comparison program. General satisfaction with the program will be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Mentoring to be Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Planning to be Active

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

High School Teachers

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

Principal Investigator

The Ohio State University Martha S. Pitzer Center for Women, Children and Youth

Phone: 16142924578

Email: smith.5764@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place