Clinical trial NCT02329262: A Skills-based RCT for Physical Activity Using Peer Mentors
Official title: A Skills-based RCT for Physical Activity Using Peer Mentors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Obesity
Motor Activity
Keywords: exercise
mentors
health education
obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 571
Sex: ALL
Minimum age (years): 14
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Change in Body Mass Index From T1 to T3
timeFrame: T1 (Baseline) to T3 (9 months-post baseline)
measure: Change in Total Body Weight From T1 to T3
timeFrame: T1 (baseline) to T3 (9-month post baseline)
measure: Change in Pounds of Body Fat From T1 to T3
timeFrame: T1 ( Baseline) to T3 (9-months post baseline)
Secondary outcomes:
measure: Moderate Physical Activity (Daily)
timeFrame: 9 months
measure: Outcome Expectancies Scale
timeFrame: 9 months
measure: Exercise Self-Efficacy Scale
timeFrame: 9 months
measure: Outcome Expectations Scale
timeFrame: 9 months
measure: Social Support From Family and Friends to Exercise
timeFrame: 9 months
measure: Vigorous Physical Activity
timeFrame: 9 months
Other outcomes:
measure: Sessions Attended
timeFrame: 3 months
Locations:
city: Bidwell
country: United States
facility: River Valley High School
state: Ohio
city: Chillicothe
country: United States
facility: Chillicothe High School
state: Ohio
city: Chillicothe
country: United States
facility: Huntington Local High School
state: Ohio
city: Chillicothe
country: United States
facility: Unioto High School
state: Ohio
city: Chillicothe
country: United States
facility: Zane Trace High School
state: Ohio
city: Coal Grove
country: United States
facility: Dawson-Bryant High School
state: Ohio
city: Franklin Furnace
country: United States
facility: Green High School
state: Ohio
city: Ironton
country: United States
facility: Ironton High School
state: Ohio
city: Jackson
country: United States
facility: Jackson High School
state: Ohio
city: Latham
country: United States
facility: Western High School
state: Ohio
city: New Boston
country: United States
facility: New Boston High School
state: Ohio
city: Oak Hill
country: United States
facility: Oak Hill High School
state: Ohio
city: Piketon
country: United States
facility: Piketon High School
state: Ohio
city: Portsmouth
country: United States
facility: Clay Local High School
state: Ohio
city: Portsmouth
country: United States
facility: West Portsmouth High School
state: Ohio
city: Racine
country: United States
facility: Southern Local High School
state: Ohio
city: South Point
country: United States
facility: South Point High School
state: Ohio
city: Stewart
country: United States
facility: Federal Hocking High School
state: Ohio
city: Sugar Grove
country: United States
facility: Berne Union High School
state: Ohio
city: Waverly
country: United States
facility: Waverly High School
state: Ohio
Study officials:
affiliation: OSU College of Nursing
name: Laureen H Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Rick L Petosa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.