NCT02329262

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 5, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

December 17, 2014

Results QC Date

February 24, 2023

Last Update Submit

February 11, 2025

Conditions

Keywords

exercisementorshealth educationobesity

Outcome Measures

Primary Outcomes (3)

  • Change in Body Mass Index From T1 to T3

    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

    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

    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 Outcomes (6)

  • Moderate Physical Activity (Daily)

    9 months

  • Outcome Expectancies Scale

    9 months

  • Exercise Self-Efficacy Scale

    9 months

  • Outcome Expectations Scale

    9 months

  • Social Support From Family and Friends to Exercise

    9 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Sessions Attended

    3 months

Study Arms (4)

Mentoring to be Active

EXPERIMENTAL

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

Planning to be Active

ACTIVE COMPARATOR

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

Peer Mentors

NO INTERVENTION

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

High School Teachers

NO INTERVENTION

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

Interventions

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

Also known as: peer mentoring
Mentoring to be Active

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

Also known as: Teacher PBA
Planning to be Active

Eligibility Criteria

Age14 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • th or 10th grade students as participants
  • th 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

You may not qualify if:

  • Peer mentors with a BMI (for age and gender) above the 85th percentile or below the 5th percentile at the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

River Valley High School

Bidwell, Ohio, 45614, United States

Location

Chillicothe High School

Chillicothe, Ohio, 45601, United States

Location

Huntington Local High School

Chillicothe, Ohio, 45601, United States

Location

Unioto High School

Chillicothe, Ohio, 45601, United States

Location

Zane Trace High School

Chillicothe, Ohio, 45601, United States

Location

Dawson-Bryant High School

Coal Grove, Ohio, 45638, United States

Location

Green High School

Franklin Furnace, Ohio, 45629, United States

Location

Ironton High School

Ironton, Ohio, 45638, United States

Location

Jackson High School

Jackson, Ohio, 45640, United States

Location

Western High School

Latham, Ohio, 45646, United States

Location

New Boston High School

New Boston, Ohio, 45662, United States

Location

Oak Hill High School

Oak Hill, Ohio, 45656, United States

Location

Piketon High School

Piketon, Ohio, 45661, United States

Location

Clay Local High School

Portsmouth, Ohio, 45662, United States

Location

West Portsmouth High School

Portsmouth, Ohio, 45663, United States

Location

Southern Local High School

Racine, Ohio, 45771, United States

Location

South Point High School

South Point, Ohio, 45680, United States

Location

Federal Hocking High School

Stewart, Ohio, 45778, United States

Location

Berne Union High School

Sugar Grove, Ohio, 43155, United States

Location

Waverly High School

Waverly, Ohio, 45690, United States

Location

Related Publications (3)

  • 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.

    PMID: 27257081BACKGROUND
  • 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.

    PMID: 27321677BACKGROUND
  • 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.

MeSH Terms

Conditions

Health BehaviorObesityMotor ActivityHealth Education

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Results Point of Contact

Title
Principal Investigator
Organization
The Ohio State University Martha S. Pitzer Center for Women, Children and Youth

Study Officials

  • Laureen H Smith, PhD

    OSU College of Nursing

    PRINCIPAL INVESTIGATOR
  • Rick L Petosa, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 31, 2014

Study Start

September 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 5, 2025

Results First Posted

March 5, 2025

Record last verified: 2025-02

Locations