A Skills-based RCT for Physical Activity Using Peer Mentors

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Skills-based RCT for Physical Activity Using Peer Mentors

Conditions
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Health Behavior, Obesity, Motor Activity

Intervention / Treatment
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* Behavioral: Mentoring to be Active with Accelerometers
* Behavioral: Planning to be Active with Accelerometers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentoring to be Active<br>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<br>* Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.<br>* Other names: peer mentoring;|
| Active Comparator: Planning to be Active<br>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<br>* Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.<br>* Other names: Teacher PBA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcomes | body mass index (measured), body fatness/percentage (measured) | Change is being assesed from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Activity of Participants with Accelerometers | accelerometers; subjects to wear devices for 7 days at each data collection time point | 9 months | 
| Daily Activity of Teachers with Accelerometers | accelerometers; subjects to wear devices for 7 days at each data collection time point | 9 months | 
| Ease of Use | cognitive interviews conducted to assess satisfaction; ease of use, acceptability of curriculum. Conducted with teen mentors and classroom teachers | 3 months | 
| Daily Physical Activity | Participants will wear accelerometers for 7 straight days at each data collect time point | 9 months | 
| Healthy Lifestyle Behaviors Scale | 12 item, 5 point Likert Scale asking about participants agreement or disagreement with statements about daily physical activity, dietary habits, and sedentary behaviors. | 9 months | 
| Outcome Expectancies Scale | 40 item, 6 -point Likert Summative Scale focusing on psychological determinants of physical activity. | 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. | 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. | 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. | 9 months | 
| Self-Regulation of Exercise Scale | 43 item, 6 point Likert measure with 6 subscales asking about: exercise self-monitoring (5 items), exercise goal setting (9 items), planned social support (9 items), self-reward for exercise (9 items), time management for exercise (4 items), and overcoming barriers to exercise (7 items) | 9 months | 
| Environmental Determinants of Exercise Scale | Participants respond to how household members (dad, mom, brother, sister, grandparent, or other relative) encouraged 5 specified physical activity behaviors. Participants respond to how strongly they agree or disagree to 6 situations in which their own neighborhood determines their own physical activity. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, mentors, health education, obesity