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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Patricia M West, PhD, RN
- 電話番号：517-432-8356
- メール：westpatr@msu.edu
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Activity
時間枠：Baseline and at 16 weeks
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Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph. |
Baseline and at 16 weeks
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of Intervention
時間枠：At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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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
時間枠：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
時間枠：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
|
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Multidimensional Scale of Perceived Social Support (MSPSS)
時間枠：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
|
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Multidimensional Self-efficacy for Exercise (MSES)
時間枠：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
|
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Body Mass Index (BMI)
時間枠：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
時間枠：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
|
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Calories Burned
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Patricia M West, PhD, RN、Michigan State University
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- STUDY202600294
- 1K01NR022135-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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