Body Composition, Exercise, Physical Activity
Conditions
Keywords
Physical Activity, Body Composition, Health Behavior
Brief summary
The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors. Building and reinforcing skills, MPBA+F mitigates resource stressors and strengthens protective factors by providing culturally appropriate knowledge and skills to improve the sustainability of physical activity at home without the use of exercise equipment. By strengthening social support through peer and friendship networks and family-based support, MPBA+F responds to the unique needs of rural Appalachians in a culturally responsive way. This study targets physical activity among children with overweight, obesity, or extreme obesity because rural Appalachian communities identify sedentary activity as a key contributor to the high rates of obesity and diabetes risk among youth.
Detailed description
Appalachians die more frequently and at younger ages from obesity-related conditions than those living elsewhere. High prevalence of overweight, obesity, and extreme obesity in Appalachian children increases the severity of diabetes. In rural Appalachia, the diabetes mortality rate is 11% higher than the national rate.Over the course of two years, this study will test the effects of the Mentored Planning to be Active + Family intervention on physical activity outcomes (MVPA, exercise "bouts", sedentary behavior) and health outcomes (body composition: BMI, body fat, % body fat, weight) among rural Appalachian 7/8th grade children suffering from overweight and obesity. Having teens deliver the content via structured peer mentoring increases social support, motivation, and self-regulation to sustain PA behaviors to improve health outcomes as children enter high school. Using local residents for intervention delivery leverages rural Appalachians' preference to receive health information via established social networks and extends delivery of the program into the community. This study is a community-based randomized controlled trial targeting 7th grade students in rural Appalachia. Half (n = 144) will receive MPBA+F; the other half (n = 144) will receive self-guided (usual care) modules. Tenth-grade (n = 73) students from the same rural Appalachian counties will serve as peer mentors delivering MPBA for the peer mentoring group. Parents will provide a family reinforcement program during 8th grade and provide assessments of child behaviors and health outcomes. The long-term goal is to reduce the high rates of OW, OB/EO and type 2 diabetes in Appalachia youth through effective, sustainable interventions. Improving self-regulation, self-efficacy, and social support to increase intentional exercise and MVPA among underserved youth suffering from early-onset OB/EO builds healthier lifestyle behaviors at a critical development time.
Interventions
BEHAVIORALMentoring to be Active plus Family
Ten, structured peer mentoring sessions (once a week) covering new content each week and guided skill-building and practice. The MPBA sessions target increasing daily physical activity and replacing sugary drinks with water for hydration. Mentoring sessions are conducted virtually. A 6-month family reinforcement program follows with a reinforcement packet sent to child participants' homes once a month.
BEHAVIORALTracking Health and Fitness
10 self-guided, self-paced modules mailed to child participants home.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Trained research assistants who will collect data and survey measures are blinded to study condition of each participant.
Intervention model description
For this community-based study, a stratified randomized-controlled clinical trial will evaluate MPBA+F among 7/8th grade children with overweight or obesity recruited during years 1 and 2 of the study from rural Appalachian counties. Stratification by biological sex to have equal numbers of males and females will occur. Investigators will recruit 288 children to participate. Half will be randomized to receive MPBA+F; the other half will receive a comparison program of 10 weekly, self-guided modules from mailed to their home. By following participants from the start of 7th grade (baseline) through the middle of 8th grade, longer-term effects on PA outcomes and body composition can be determined. Differences in outcomes are explored by examining sub-group differences on effects. A sub-set of parents from both study conditions will be recruited (72 parents from each condition) to provide child assessments of perceived PA behaviors and perceived child health.
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Children: * enrolled in 7th grade at the start of the study, * have a body mass index percentile of 85th or greater for age and gender, * not under medical care for OB or type 1 diabetes, * have reliable internet connection at home, * have access to a computer, laptop or tablet at home, * not expected to move from the participating county before the conclusion of the study. Parents: * read at a 5th grade-level, * speak English, * have a home-mailing address (not PO box), * have a working telephone number, and * are not expected to move from the participating county before study conclusion. High school peer mentors: * are in either 10th or 11th grade at the start of the recruitment, * reside in a targeted county, * interested in working with peers, supporting others, and striving to cultivate their own health-supportive behaviors, * have reliable internet connection at home, * have access to a computer, laptop or tablet at home, * are not expected to move before the intervention ends, * can speak English, * are recommended by a teacher, school advisor, or counselor.
Exclusion criteria
Child: * not in 7th grade at the start of the study. * not able to read or Speak English; * not classified as either overweight or obese at start of study. Parents : \- not able to read or speak English. High school peer mentors: \- cannot speak and read English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Moderate-to-Vigorous Physical Activity (MVPA) | baseline and 9 months post intervention | Number of minutes spent in Moderate-to-Vigorous Physical Activity (MVPA) over a 7-day period is collected by accelerometry. The total number of minutes spent in MVPA is measured at baseline and again 9 months post intervention as a sum of the MVPA minutes across a 7-day period at each time point. The change in minutes of daily Moderate-to-Vigorous Physical Activity (MVPA) from baseline to follow up was assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer | baseline and 9 months post baseline | The Tanita 430-DCU Body Composition Analyzer is an FDA-cleared, dual-frequency bioelectrical impedance analysis (BIA) monitor that was used to measure anthropometric body composition through 3 measures (raw weight, body fat mass, body mass index). The total body composition scores were measured and compared for changes at each time point to determine the percentage of change in body composition. Lower scores indicate better outcomes. There is not a total score range available due to possible individual variability in body composition. |
Countries
United States
Participant flow
Recruitment details
A multi-phase recruitment plan was followed. Potential participants were recruited from local institutional offices and through social media advertisements including Facebook and Instagram. Children could participate even if parents did not participate in the study.
Pre-assignment details
Potential participants who completed study inclusion screening but not selected to participate were: not residing in participating counties or not classified as suffering from either overweight or obesity.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 35 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 23.25 years STANDARD_DEVIATION 2.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 12 |
Outcome results
None listed