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Completed

NCT Number: NCT02329262

A Skills-based RCT for Physical Activity Using Peer Mentors

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

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Key information

Conditions

Health Behavior Adherence Interventions Behavior Body Weight Health Education Medication Adherence Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

14 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

River Valley High School, Bidwell, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 9th or 10th grade students as participants
  • 11th or 12th grade students as mentors
  • Classroom teachers who instruct health education or physical education to 9th and 10th grade students.
  • Not expected to move from school prior to conclusion of study
  • Speaks English

Exclusion criteria

  • Peer mentors with a BMI (for age and gender) above the 85th percentile or below the 5th percentile at the start of the study

Treatment and study plan

Mentoring to be Active with Accelerometers

Behavioral

Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.

Other names: peer mentoring

Planning to be Active with Accelerometers

Behavioral

Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.

Other names: Teacher PBA

Primary outcomes

  1. Change in Body Mass Index From T1 to T3

    Time frame: 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.

  2. Change in Total Body Weight From T1 to T3

    Time frame: T1 (baseline) to T3 (9-month post baseline)

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

  3. Change in Pounds of Body Fat From T1 to T3

    Time frame: 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.

Secondary outcomes

  1. Moderate Physical Activity (Daily)

    Time frame: 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

  2. Outcome Expectancies Scale

    Time frame: 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.

  3. Exercise Self-Efficacy Scale

    Time frame: 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.

  4. Outcome Expectations Scale

    Time frame: 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)

  5. Social Support From Family and Friends to Exercise

    Time frame: 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.

  6. Vigorous Physical Activity

    Time frame: 9 months

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

Other outcomes

  1. Sessions Attended

    Time frame: 3 months

    Average number of sessions attended by participants

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2014
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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