Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Patricia M West, PhD, RN
- Numéro de téléphone: 517-432-8356
- E-mail: westpatr@msu.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
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Exclusion Criteria:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical Activity
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of Intervention
Délai: 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
|
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Acceptability of Intervention
Délai: 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
|
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Virtual Reality Symptoms
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
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Heart Rate
Délai: 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
|
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Active Zone Minutes per Day
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Patricia M West, PhD, RN, Michigan State University
Publications et liens utiles
Publications générales
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY202600294
- 1K01NR022135-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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