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Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity

30. oktober 2026 oppdatert av: Patricia West, Michigan State University

Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. This project aims to address these gaps by engaging adolescents with ID and their stakeholders supporting ID as co-researchers to design, adapt, and pilot-test a virtual reality (VR)-based PA intervention tailored to their needs. The long-term goal is to dismantle factors to improve health outcomes for adolescents with ID through innovative, collaborative research that enhances health literacy, increases PA, and lowers CV health risks. The objectives of this study will address three specific aims: 1) adapt and validate research instruments by collaborating with adolescents with ID and their ID stakeholders to incorporate common language in measures for assessing health outcomes; 2) evaluate and select VR-based PA programs by engaging co-researchers in identifying effective VR exergame interventions for improving health outcomes through PA; and 3) pilot-test the VR PA intervention, which incorporates peer support. We will assess feasibility, acceptability, and preliminary efficacy of our 16-week VR exergame PA intervention using co-adapted measures and biologic CV risk measures. A quasi-experimental mixed-methods approach will be used, guided by our Logic Model. Preliminary evidence highlights the potential of interactive, technology-driven PA to address CV risks while fostering peer engagement and optimal self-efficacy to manage health. The expected outcomes are: 1) validated measures through greater health literacy, and 2) a co-designed intervention to reduce CV risks that helps adolescents with ID to take an active role in their health. By addressing critical gaps in health literacy, self-efficacy, and PA, this work advances healthcare practices and supports long-term improvements in public health.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

77

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Patricia M West, PhD, RN
  • Telefonnummer: 517-432-8356
  • E-post: westpatr@msu.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

11 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria: The study will be offered to adolescents with ID who meet eligibility criteria and provide assent and parental consent. Adolescents aged 11-17 years will be eligible if: 1) diagnosed with mild to moderate ID, 2) able to communicate through spoken language or use of augmentative and alternative communication (AAC), 3) understand spoken English, 4) absence of medical contraindications to PA and playing VR games, 5) parent/guardian agrees to attend virtual meetings and adolescents, and 6) internet access.

-

Exclusion Criteria:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single

Single arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys

The intervention will be delivered via home setting of the study participant (adolescent with ID). Baseline Home Visit; week 1: All pre-intervention baseline measures will be obtained, accelerometer will be fitted and applied. Home Visit 2; week 2: The participant will utilize the VR technology three sessions per week (weeks 3-16) for approximately 10 minutes per exercise session following instructions on use. Visit 3; Virtual; week 4: One of the three VR sessions per week will be virtual peer group interactions, guided by study staff. Virtual peer groups will utilize the VR technology together for at least one session of the three sessions per week for approximately 10 minutes per exercise session during weeks 4-16. Educational materials include: visual supports to guide VR use along with study team's contact information throughout the intervention. Study Completion Home Visit; after week 15: Follow up data collection. Virtual Week 16; Optional: Qualitative follow-up data collection.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Activity
Tidsramme: Baseline and at 16 weeks

Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph.

Baseline and at 16 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of Intervention
Tidsramme: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, validated measure to evaluate the feasibility of immersive VR intervention.

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Acceptability of Intervention
Tidsramme: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, validated measure to evaluate the acceptability of immersive VR intervention

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Virtual Reality Symptoms
Tidsramme: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, to measure the symptoms one experiences while or after being in a VR environment. Symptoms that have been associated with VR use (general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness with eyes closed, vertigo)

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Tidsramme: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

12-item, validated measure to assess perceptions of social support adequacy from three sources: family, friends, and significant other (subscales)

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Self-efficacy for Exercise (MSES)
Tidsramme: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

9-item, measure to assess three behavioral domains (i.e., task efficacy, coping efficacy, scheduling efficacy) that relate to exercise behavior among individuals and exercise contexts. The three behavioral domains are useful in determining the dimensions that influence exercise in a particular population segment

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Body Mass Index (BMI)
Tidsramme: At baseline, 16 weeks

Measure of estimated body fat based on a person's height and weight. Portable stadiometer and scale use to measure height and weight

At baseline, 16 weeks
Waist circumference
Tidsramme: At baseline, 16 weeks

Measure of the distance around a person's waist as a health indicator to assess risk of excess body fat for developing a chronic condition. Measuring tape utilized

At baseline, 16 weeks
Calories Burned
Tidsramme: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of the rate at which an individual burns calories based on the height, weight, age, and gender entered into an individual's app account.

Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Heart Rate
Tidsramme: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of number of individual's heart beats per minute (bpm) with various activities. Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Active Zone Minutes per Day
Tidsramme: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of the time an individual spends in different heart rate zones. Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Patricia M West, PhD, RN, Michigan State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. november 2026

Primær fullføring (Antatt)

31. januar 2029

Studiet fullført (Antatt)

31. januar 2029

Datoer for studieregistrering

Først innsendt

30. oktober 2026

Først innsendt som oppfylte QC-kriteriene

30. oktober 2026

Først lagt ut (Faktiske)

5. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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