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| ID | Type | Description | Link |
|---|---|---|---|
| 11-22-ICTSN-30 | Other Grant/Funding Number | American Diabetes Association |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mentoring to be Active plus Family (MPBA+F) | Experimental | For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules. |
|
| Tracking Health and Fitness | Active Comparator | Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentoring to be Active plus Family | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Moderate-to-Vigorous Physical Activity (MVPA) | 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. | baseline and 9 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Parent Proxy Physical Activity (PA) | PROMIS Parent Proxy Physical Activity (PA) is an 8-item instrument that measures a parent's perceptions of their child's performance of physical activity over the past 7 days. Physical actions reflect the levels of bodily movement ranging from simple static behaviors with minimal muscle activity to more complex activities requiring dynamic or sustained muscle activity and greater movement of the body. Each question has a range of values of 1-5, with a Raw Score total possible range of 8-40. Higher scores indicate better outcomes. The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported. |
Inclusion Criteria:
Children:
Parents:
High school peer mentors:
Exclusion Criteria:
Child:
Parents :
- not able to read or speak English.
High school peer mentors:
- cannot speak and read English.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University College of Nursing | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40018636 | Derived | Smith LH, Petosa RL, Tan A, Shankle S, Phosri Y. Randomised trial of Mentored 'Planning to be Active+Family' [MPBA+F] for Appalachian youth at risk for diabetes: virtual delivery protocol. BMJ Public Health. 2024 Nov 2;2(2):e000798. doi: 10.1136/bmjph-2023-000798. eCollection 2024 Dec. |
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The American Diabetes Association policies and guidance for availability and sharing of research results and resources will be followed. All data that can be shared without compromising human subject protections will be shared to an approved open data repository as required. Study-related data will be anonymized, catalogued, and stored per federal guidelines and university policies. A public use, de-identified dataset will be available to qualified investigators upon request after analyses have been conducted and findings have been published. All identifiers will be removed. A request in writing, stating intended use must be submitted. Data sets will be accompanied by a data dictionary, both derived and raw data. The most cost-effective means for sharing data will be followed after a data sharing agreement has been reached. Curricular materials will be provided at no charge.
Within 6 months of publication or 18 months if results are not published.
A written request for any study data, protocols or other materials must be sent to Principal Investigator. Once approved, materials will be made available by agreement.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mentoring to be Active Plus Family (MPBA+F) | For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules. Mentoring 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. |
| FG001 | Tracking Health and Fitness | Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA. Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home. |
| FG002 | Parents of Children Assigned to Mentoring to be Active Plus Family (MPBA+F) | Parents who consented to participate in the study of children assigned to the intervention arm (MPBA+F) |
| FG003 | Parents of Children Assigned to the Tracking Health and Fitness (Comparison) Group | Parents who consented to participate in study for children assigned to the Tracking Health and Fitness (comparison) group |
| FG004 | Peer Mentors | High school aged peer mentors who delivered the Mentoring to be Active plus Family (MPBA +F) Intervention to the children assigned to the MPBA+F arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mentoring to be Active Plus Family (MPBA+F) | For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules. Mentoring 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Daily Moderate-to-Vigorous Physical Activity (MVPA) | 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. | Posted | Mean | Standard Deviation | MVPA minutes per week | baseline and 9 months post intervention |
|
Adverse event data were collected for 9 months for each cohort of participants (from baseline to the end of follow up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mentoring to be Active Plus Family (MPBA+F) | For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules. Mentoring 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laureen H. Smith, Principal Investigator | The Ohio State University | 6142924578 | smith.5764@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 13, 2026 | May 13, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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Trained research assistants who will collect data and survey measures are blinded to study condition of each participant.
|
|
| Tracking Health and Fitness | Behavioral | 10 self-guided, self-paced modules mailed to child participants home. |
|
| baseline and 9 months post baseline |
| Baseline, 9 months post-baseline |
| PROMIS Parent Proxy Global Health | PROMIS Parent Proxy Global Health is a 7-item instrument that measures parent perceptions of their child's overall general health, physical health, mental health, social health and quality of life. Each question uses a 5-point likert scale ranging from 1-5, with a total possible score range of 7-35. Higher scores represent better health. The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported. | Baseline, 9 months post-baseline |
| BG001 | Tracking Health and Fitness | Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA. Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home. |
| BG002 | Parents of Children Assigned to MPBA+F | Parents of children assigned to MPBA+F who consented to participate in study to provide data on parent perceptions |
| BG003 | Parents of Children Assigned to Tracking Health an Fitness | Parents of children assigned to Tracking Health and Fitness who consented to participate in the study to provide data on parent perceptions |
| BG004 | Peer Mentors | High school aged mentors who delivered the Mentoring to be Active plus Family intervention to children assigned to the MPBA+F arm |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Tracking Health and Fitness | Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA. Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home. |
|
|
| Secondary | Body Composition as Measured by Tanita 430-DCU Body Composition Analyzer | 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. | Posted | Mean | Standard Deviation | mean percent change in body composition | baseline and 9 months post baseline |
|
|
|
| Other Pre-specified | PROMIS Parent Proxy Physical Activity (PA) | PROMIS Parent Proxy Physical Activity (PA) is an 8-item instrument that measures a parent's perceptions of their child's performance of physical activity over the past 7 days. Physical actions reflect the levels of bodily movement ranging from simple static behaviors with minimal muscle activity to more complex activities requiring dynamic or sustained muscle activity and greater movement of the body. Each question has a range of values of 1-5, with a Raw Score total possible range of 8-40. Higher scores indicate better outcomes. The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9 months post-baseline |
|
|
|
| Other Pre-specified | PROMIS Parent Proxy Global Health | PROMIS Parent Proxy Global Health is a 7-item instrument that measures parent perceptions of their child's overall general health, physical health, mental health, social health and quality of life. Each question uses a 5-point likert scale ranging from 1-5, with a total possible score range of 7-35. Higher scores represent better health. The individual raw score for 9-month post baseline measures were compared to individual baseline raw scores to calculate the change. The mean for the groups are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9 months post-baseline |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Tracking Health and Fitness | Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA. Tracking Health and Fitness: 10 self-guided, self-paced modules mailed to child participants home. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Parents of Children Assigned to Mentoring to be Active Plus Family (MPBA+F) | Parents of children assigned to MPBA+F who consented to participate in study to provide data on parent perceptions | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Parents of Children Assigned to the Tracking Health and Fitness Group | Parents of children assigned to Tracking Health and Fitness who consented to participate in the study to provide data on parent perceptions | 0 | 11 | 0 | 11 | 0 | 11 |
| EG004 | Peer Mentors | High school aged mentors who delivered the Mentoring to be Active plus Family intervention to children assigned to the MPBA+F arm | 0 | 12 | 0 | 12 | 0 | 12 |
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