Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
NCT07919171, Not applicable, Not yet recruiting, Michigan State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity | ClinicalTrials.gov |
| NCT number | NCT07919171 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 77 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Michigan State University | ClinicalTrials.gov |
| Conditions | Physical Activity, Intellectual Disabilities, Cardiovascular Health | ClinicalTrials.gov |
| Interventions | Virtual reality physical activity health promotion intervention | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Physical Activity | Baseline and at 16 weeks | Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph. | ClinicalTrials.gov |
| Secondary | Feasibility of Intervention | At 4 weeks, 8 weeks, 12 weeks, and 16 weeks | 4-item, validated measure to evaluate the feasibility of immersive VR intervention. | ClinicalTrials.gov |
| Secondary | Acceptability of Intervention | At 4 weeks, 8 weeks, 12 weeks, and 16 weeks | 4-item, validated measure to evaluate the acceptability of immersive VR intervention | ClinicalTrials.gov |
| Secondary | Virtual Reality Symptoms | 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) | ClinicalTrials.gov |
| Secondary | Multidimensional Scale of Perceived Social Support (MSPSS) | 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) | ClinicalTrials.gov |
| Secondary | Multidimensional Self-efficacy for Exercise (MSES) | 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 | ClinicalTrials.gov |
| Secondary | Body Mass Index (BMI) | 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 | ClinicalTrials.gov |
| Secondary | Waist circumference | 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 | ClinicalTrials.gov |
| Secondary | Calories Burned | 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 | ClinicalTrials.gov |
| Secondary | Heart Rate | 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 | ClinicalTrials.gov |
| Secondary | Active Zone Minutes per Day | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 33
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 16999781 | BACKGROUND | PubMed |
| 18664046 | BACKGROUND | PubMed |
| 21518980 | BACKGROUND | PubMed |
| 21948121 | BACKGROUND | PubMed |
| 25539396 | BACKGROUND | PubMed |
| 26058685 | BACKGROUND | PubMed |
| 26186934 | BACKGROUND | PubMed |
| 26307204 | BACKGROUND | PubMed |
| 28851459 | BACKGROUND | PubMed |
| 28984406 | BACKGROUND | PubMed |
| 29231285 | BACKGROUND | PubMed |
| 29248807 | BACKGROUND | PubMed |
| 29277930 | BACKGROUND | PubMed |
| 29477332 | BACKGROUND | PubMed |
| 29480777 | BACKGROUND | PubMed |
| 29949427 | BACKGROUND | PubMed |
| 30071588 | BACKGROUND | PubMed |
| 30113733 | BACKGROUND | PubMed |
| 30353637 | BACKGROUND | PubMed |
| 30648902 | BACKGROUND | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| K01NR022135 | Advancing Cardiovascular Health Among Adolescents with Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity | West, Patricia Marie | HENRY FORD HEALTH + MICHIGAN STATE UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF NURSING RESEARCH | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)