A Skills-based RCT for Physical Activity Using Peer Mentors

Obesity Clinical Trial

Official title:

A Skills-based RCT for Physical Activity Using Peer Mentors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329262
• Other study ID #: 2014B0094
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Motor Activity
• Obesity

Intervention

Behavioral:
• Mentoring to be Active with Accelerometers
Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age in years and month at start of study	1 month
Other	Sessions attended	number of sessions attended by subjects; both classroom and mentoring	3 months
Other	Gender	male or female gender of participants at start of study	1 month
Other	Grade in School	Grade in school at the start of study.	1 month
Other	Zip Code	zip code of primary residence of participants at start of study	1 month
Other	race or ethnicity	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.	1month
Other	Household Members	Number of persons living in the primary residence with the participant. Household member relationship to participant will be collected.	1 month
Primary	Health Outcomes	body mass index (measured), body fatness/percentage (measured)	Change is being assesed from baseline to 9 months
Secondary	Daily Activity of Participants with Accelerometers	accelerometers; subjects to wear devices for 7 days at each data collection time point	9 months
Secondary	Daily Activity of Teachers with Accelerometers	accelerometers; subjects to wear devices for 7 days at each data collection time point	9 months
Secondary	Ease of Use	cognitive interviews conducted to assess satisfaction; ease of use, acceptability of curriculum. Conducted with teen mentors and classroom teachers	3 months
Secondary	Daily Physical Activity	Participants will wear accelerometers for 7 straight days at each data collect time point	9 months
Secondary	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
Secondary	Outcome Expectancies Scale	40 item, 6 -point Likert Summative Scale focusing on psychological determinants of physical activity.	9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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