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Lo studio clinico NCT05758441 per Attività fisica, Esercizio, Composizione corporea è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Mentoring to be Active for Rural Appalachia Children

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05758441 è uno studio interventistico per Attività fisica, Esercizio, Composizione corporea, attualmente in arruolamento. Avviato il 7 marzo 2023, prevede di arruolare 432 partecipanti. Sotto la guida di l'Università statale dell'Ohio, dovrebbe concludersi entro il 14 novembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 maggio 2025.
Sommario breve
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.
Descrizione dettagliata
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.
Titolo ufficiale

Mentoring to be Active: Peer Mentoring to Mitigate Obesity and Extreme Obesity in Rural Appalachian Children

Condizioni
Attività fisicaEsercizioComposizione corporea
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • GR130196
  • 11-22-ICTSN-30 (Altro numero di finanziamento) (American Diabetes Association)
Numero NCT
Data di inizio (effettiva)
2023-03-07
Ultimo aggiornamento pubblicato
2025-05-29
Data di completamento (stimata)
2025-11-14
Arruolamento (previsto)
432
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Physical Activity, Body Composition, Health Behavior
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleMentoring 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.
Comparatore attivoTracking 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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in Daily Physical Activity
Daily levels of moderate and vigorous physical activity collected by accelerometry.
7 days- collected at baseline, at week 12 when mentoring sessions end, and at 9 months when the reinforcement program ends
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Change in Body Composition
Anthropometric (body composition- raw weight, BMI, body fat) using the Tanita 430-DCU Body Composition Analyzer
baseline, at 12 weeks when mentoring sessions end, and at 9 months when the reinforcement program ends.
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Età minima
11 Years
Sessi idonei
Tutti
Accetta volontari sani

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.

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.

Ohio State University logoUniversità statale dell'Ohio455 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Laureen Smith, PhD, 614-292-4578, [email protected]
Contatto: Sandra Solove, MA, 614-247-8366, [email protected]
1 Centri dello studio in 1 paesi

Ohio

Ohio State University College of Nursing, Columbus, Ohio, 43210, United States
Laureen Smith, PhD, Contatto, [email protected]
In arruolamento