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A Skills-based RCT for Physical Activity Using Peer Mentors

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ClinicalTrials.gov Identifier: NCT02329262
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Laureen Smith, Ohio State University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Health Behavior Obesity Motor Activity Behavioral: Mentoring to be Active with Accelerometers Behavioral: Planning to be Active with Accelerometers Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 805 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Skills-based RCT for Physical Activity Using Peer Mentors
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mentoring to be Active
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
Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
Other Name: peer mentoring

Active Comparator: Planning to be Active
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
Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Other Name: Teacher PBA




Primary Outcome Measures :
  1. Health Outcomes [ Time Frame: Change is being assesed from baseline to 9 months ]
    body mass index (measured), body fatness/percentage (measured)


Secondary Outcome Measures :
  1. Daily Activity of Participants with Accelerometers [ Time Frame: 9 months ]
    accelerometers; subjects to wear devices for 7 days at each data collection time point

  2. Daily Activity of Teachers with Accelerometers [ Time Frame: 9 months ]
    accelerometers; subjects to wear devices for 7 days at each data collection time point

  3. Ease of Use [ Time Frame: 3 months ]
    cognitive interviews conducted to assess satisfaction; ease of use, acceptability of curriculum. Conducted with teen mentors and classroom teachers

  4. Daily Physical Activity [ Time Frame: 9 months ]
    Participants will wear accelerometers for 7 straight days at each data collect time point

  5. Healthy Lifestyle Behaviors Scale [ Time Frame: 9 months ]
    12 item, 5 point Likert Scale asking about participants agreement or disagreement with statements about daily physical activity, dietary habits, and sedentary behaviors.

  6. Outcome Expectancies Scale [ Time Frame: 9 months ]
    40 item, 6 -point Likert Summative Scale focusing on psychological determinants of physical activity.

  7. 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.

  8. 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.

  9. 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.

  10. Self-Regulation of Exercise Scale [ Time Frame: 9 months ]
    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)

  11. Environmental Determinants of Exercise Scale [ Time Frame: 9 months ]

    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.



Other Outcome Measures:
  1. Age [ Time Frame: 1 month ]
    Age in years and month at start of study

  2. Sessions attended [ Time Frame: 3 months ]
    number of sessions attended by subjects; both classroom and mentoring

  3. Gender [ Time Frame: 1 month ]
    male or female gender of participants at start of study

  4. Grade in School [ Time Frame: 1 month ]
    Grade in school at the start of study.

  5. Zip Code [ Time Frame: 1 month ]
    zip code of primary residence of participants at start of study

  6. race or ethnicity [ Time Frame: 1month ]
    self identified race and ethnicity at the start of the study. Race will include: Caucasian; Black/African American; Asian American; Native American; Other. Ethnicity will include: Hispanic or Latino.

  7. Household Members [ Time Frame: 1 month ]
    Number of persons living in the primary residence with the participant. Household member relationship to participant will be collected.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329262


Locations
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Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Laureen H Smith, PhD OSU College of Nursing
Principal Investigator: Rick L Petosa, PhD Ohio State University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laureen Smith, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02329262    
Other Study ID Numbers: 2014B0094
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by Laureen Smith, Ohio State University:
exercise
mentors
health education
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight