Health Behavior, Motor Activity, Obesity
Conditions
Keywords
exercise, mentors, health education, obesity
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.
Interventions
BEHAVIORALMentoring to be Active with Accelerometers
Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
BEHAVIORALPlanning 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index From T1 to T3 | 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. |
| Change in Total Body Weight From T1 to T3 | T1 (baseline) to T3 (9-month post baseline) | Change in total body weight from baseline to 9 months post-baseline. |
| Change in Pounds of Body Fat From T1 to T3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate Physical Activity (Daily) | 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 |
| Outcome Expectancies Scale | 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. |
| Exercise Self-Efficacy Scale | 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. |
| Outcome Expectations Scale | 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) |
| Social Support From Family and Friends to Exercise | 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. |
| Vigorous Physical Activity | 9 months | Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaureen H Smith, PhD
OSU College of Nursing
PRINCIPAL_INVESTIGATORRick L Petosa, PhD
Ohio State University
Participant flow
Recruitment details
students attending the same school are expected to socialize together; thus, a Group-Randomized Control Trial (G-RCT) is necessary to avoid the risk of cross-contamination.There were 20 high schools recruited in 3 waves, with 4 in Wave 1, 8 in Wave 2, and 8 in Wave 3, for a total of schools. For each wave of schools, half of the schools were randomly assigned to each condition-intervention \[MBA\] and comparison \[PBA\]-for a total of 10 schools in each of the two conditions by study's end.
Participants by arm
| Arm | Count |
|---|---|
| Mentoring to be Active Trained teen mentors will deliver the 10- session physical activity curriculum to high school students in a school setting. Physical activity will be measured with accelerometers. | 252 |
| Planning to be Active High school teachers will deliver the 10- session physical activity curriculum (usual care) to high school students enrolled in health education courses. Physical activity will be measured with accelerometers. | 248 |
| Peer Mentors 11th and 12th grade level trained mentors who lead the Mentoring to be Active (MBA) as intervention specialists | 66 |
| High School Teachers High School teachers who taught the usual care health classes. | 5 |
| Total | 571 |
Baseline characteristics
| Characteristic | Planning to be Active | Peer Mentors | Mentoring to be Active | High School Teachers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 248 Participants | 66 Participants | 252 Participants | 0 Participants | 566 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Age, Continuous | 15.25 years | 16.49 years | 14.84 years | 38.38 years | 14.97 years |
| Average Number of Household Members | 4.6 number of household members STANDARD_DEVIATION 3.5 | 4.5 number of household members STANDARD_DEVIATION 3.2 | 4.3 number of household members STANDARD_DEVIATION 3.9 | 5.2 number of household members STANDARD_DEVIATION 2.8 | 4.4 number of household members STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 247 Participants | 63 Participants | 251 Participants | 4 Participants | 565 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Grade level at beginning of study 10th grade | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Grade level at beginning of study 11th-12th gradee | 0 Participants | 64 Participants | 0 Participants | 0 Participants | 64 Participants |
| Grade level at beginning of study 9th grade | 248 Participants | 0 Participants | 252 Participants | 0 Participants | 500 Participants |
| Grade level at beginning of study N/A | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 0 Participants | 15 Participants | 0 Participants | 26 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 4 Participants | 10 Participants | 1 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 219 Participants | 56 Participants | 222 Participants | 3 Participants | 500 Participants |
| Region of Enrollment United States | 248 participants | 66 participants | 252 participants | 5 participants | 627 participants |
| Sex/Gender, Customized Female | 126 Participants | 39 Participants | 130 Participants | 2 Participants | 297 Participants |
| Sex/Gender, Customized Male | 122 Participants | 27 Participants | 122 Participants | 3 Participants | 274 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 248 | 0 / 66 | 0 / 5 |
| other Total, other adverse events | 0 / 252 | 0 / 248 | 0 / 66 | 0 / 5 |
| serious Total, serious adverse events | 0 / 252 | 0 / 248 | 0 / 66 | 0 / 5 |
Outcome results
Primary
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.
Time frame: T1 (Baseline) to T3 (9 months-post baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Change in Body Mass Index From T1 to T3 | -.9257 kg/m2 | Standard Deviation 1.76 |
| Planning to be Active | Change in Body Mass Index From T1 to T3 | -.6503 kg/m2 | Standard Deviation 2.09 |
Primary
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.
Time frame: T1 ( Baseline) to T3 (9-months post baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Change in Pounds of Body Fat From T1 to T3 | -3.05 pounds | Standard Deviation 11.46 |
| Planning to be Active | Change in Pounds of Body Fat From T1 to T3 | -3.13 pounds | Standard Deviation 12.44 |
Primary
Change in Total Body Weight From T1 to T3
Change in total body weight from baseline to 9 months post-baseline.
Time frame: T1 (baseline) to T3 (9-month post baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Change in Total Body Weight From T1 to T3 | -4.96 pounds | Standard Deviation 11.38 |
| Planning to be Active | Change in Total Body Weight From T1 to T3 | 8.72 pounds | Standard Deviation 10.94 |
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. 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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Exercise Self-Efficacy Scale | 783 score on a scale | Standard Deviation 304 |
| Planning to be Active | Exercise Self-Efficacy Scale | 830 score on a scale | Standard Deviation 315 |
Secondary
Moderate Physical Activity (Daily)
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
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mentoring to be Active | Moderate Physical Activity (Daily) | 4.9 percentage of participants |
| Planning to be Active | Moderate Physical Activity (Daily) | 4.9 percentage of participants |
Secondary
Outcome Expectancies Scale
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Outcome Expectancies Scale | 81.47 score on a scale | Standard Deviation 13.6 |
| Planning to be Active | Outcome Expectancies Scale | 81.8 score on a scale | Standard Deviation 13.4 |
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. 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)
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Outcome Expectations Scale | 68.5 score on a scale | Standard Deviation 12.9 |
| Planning to be Active | Outcome Expectations Scale | 70.3 score on a scale | Standard Deviation 13.8 |
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. 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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Social Support From Family and Friends to Exercise | 29.4 score on a scale | Standard Deviation 13.3 |
| Planning to be Active | Social Support From Family and Friends to Exercise | 33.2 score on a scale | Standard Deviation 13.9 |
Secondary
Vigorous Physical Activity
Percentage of participants engaging in vigorous physical activity during the data collection period measured by accelerometers.
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring to be Active | Vigorous Physical Activity | 176 Participants |
| Planning to be Active | Vigorous Physical Activity | 198 Participants |
Post Hoc
Ease of Use
Participants will be asked to describe the ease of using the intervention curriculum and comparison program. General satisfaction with the program will be assessed.
Time frame: 3 months
Other Pre-specified
Sessions Attended
Average number of sessions attended by participants
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mentoring to be Active | Sessions Attended | 6.98 sessions | Standard Deviation 3.2 |
| Planning to be Active | Sessions Attended | 9.6 sessions | Standard Deviation 1.1 |