- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329262
A Skills-based RCT for Physical Activity Using Peer Mentors
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ohio
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Bidwell, Ohio, United States, 45614
- River Valley High School
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Chillicothe, Ohio, United States, 45601
- Chillicothe High School
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Chillicothe, Ohio, United States, 45601
- Huntington Local High School
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Chillicothe, Ohio, United States, 45601
- Unioto High School
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Chillicothe, Ohio, United States, 45601
- Zane Trace High School
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Coal Grove, Ohio, United States, 45638
- Dawson-Bryant High School
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Franklin Furnace, Ohio, United States, 45629
- Green High School
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Ironton, Ohio, United States, 45638
- Ironton High School
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Jackson, Ohio, United States, 45640
- Jackson High School
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Latham, Ohio, United States, 45646
- Western High School
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New Boston, Ohio, United States, 45662
- New Boston High School
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Oak Hill, Ohio, United States, 45656
- Oak Hill High School
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Piketon, Ohio, United States, 45661
- Piketon High School
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Portsmouth, Ohio, United States, 45662
- Clay Local High School
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Portsmouth, Ohio, United States, 45663
- West Portsmouth High School
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Racine, Ohio, United States, 45771
- Southern Local High School
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South Point, Ohio, United States, 45680
- South Point High School
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Stewart, Ohio, United States, 45778
- Federal Hocking High School
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Sugar Grove, Ohio, United States, 43155
- Berne Union High School
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Waverly, Ohio, United States, 45690
- Waverly High School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
Other Names:
|
|
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.
|
Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
Other Names:
|
|
No Intervention: Peer Mentors
11 and 12 grade-level trained mentors who lead the Mentoring to be Active (MBA) experimental group as peer mentors.
|
|
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No Intervention: High School Teachers
High School teachers who taught the usual care healh classes for the Planning to be Active (PBA) active comparator group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
T1 (Baseline) to T3 (9 months-post baseline)
|
|
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.
|
T1 (baseline) to T3 (9-month post baseline)
|
|
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. |
T1 ( Baseline) to T3 (9-months post baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
9 months
|
|
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.
|
9 months
|
|
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.
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9 months
|
|
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)
|
9 months
|
|
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.
|
9 months
|
|
Vigorous Physical Activity
Time Frame: 9 months
|
Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers.
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sessions Attended
Time Frame: 3 months
|
Average number of sessions attended by participants
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laureen H Smith, PhD, OSU College of Nursing
- Principal Investigator: Rick L Petosa, PhD, Ohio State University
Publications and helpful links
General Publications
- Smith LH, Petosa RL. A Structured Peer-Mentoring Method for Physical Activity Behavior Change Among Adolescents. J Sch Nurs. 2016 Oct;32(5):315-23. doi: 10.1177/1059840516644955. Epub 2016 May 4.
- Smith LH, Petosa RL. Effective Practices to Improve Recruitment, Retention, and Partnerships in School-Based Studies. J Pediatr Health Care. 2016 Sep-Oct;30(5):495-8. doi: 10.1016/j.pedhc.2016.05.004. Epub 2016 Jun 16. No abstract available.
- Smith LH, Petosa RL, Shoben A. Peer mentor versus teacher delivery of a physical activity program on the effects of BMI and daily activity: protocol of a school-based group randomized controlled trial in Appalachia. BMC Public Health. 2018 May 16;18(1):633. doi: 10.1186/s12889-018-5537-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Treatment Adherence and Compliance
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Obesity
- Motor Activity
- Health Behavior
- Health Education
Other Study ID Numbers
- 2014B0094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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