A Skills-based RCT for Physical Activity Using Peer Mentors

NCT ID: NCT02329262

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 571 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-11-01

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.

Conditions

Health Behavior; Obesity; Motor Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mentoring to be Active with Accelerometers

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Planning to be Active with Accelerometers

Intervention Type: BEHAVIORAL

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

Peer Mentors

11 and 12 grade-level trained mentors who lead the Mentoring to be Active (MBA) experimental group as peer mentors.

Group Type: NO_INTERVENTION

No interventions assigned to this group

High School Teachers

High School teachers who taught the usual care healh classes for the Planning to be Active (PBA) active comparator group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mentoring to be Active with Accelerometers

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

peer mentoring; Teacher PBA

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Laureen Smith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laureen H Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

OSU College of Nursing

Rick L Petosa, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

River Valley High School

Bidwell, Ohio, United States

Chillicothe High School

Chillicothe, Ohio, United States

Huntington Local High School

Chillicothe, Ohio, United States

Unioto High School

Chillicothe, Ohio, United States

Zane Trace High School

Chillicothe, Ohio, United States

Dawson-Bryant High School

Coal Grove, Ohio, United States

Green High School

Franklin Furnace, Ohio, United States

Ironton High School

Ironton, Ohio, United States

Jackson High School

Jackson, Ohio, United States

Western High School

Latham, Ohio, United States

New Boston High School

New Boston, Ohio, United States

Oak Hill High School

Oak Hill, Ohio, United States

Piketon High School

Piketon, Ohio, United States

Clay Local High School

Portsmouth, Ohio, United States

West Portsmouth High School

Portsmouth, Ohio, United States

Southern Local High School

Racine, Ohio, United States

South Point High School

South Point, Ohio, United States

Federal Hocking High School

Stewart, Ohio, United States

Berne Union High School

Sugar Grove, Ohio, United States

Waverly High School

Waverly, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27257081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27321677 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29769106 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014B0094

Identifier Type: -

Identifier Source: org_study_id