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

October 30, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Patricia M West, PhD, RN
  • Phone Number: 517-432-8356
  • Email: westpatr@msu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single

Single arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys
Behavioral: Virtual reality physical activity health promotion intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Patricia M West, PhD, RN, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

October 30, 2026

First Submitted That Met QC Criteria

October 30, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY202600294
  • 1K01NR022135-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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