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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Patricia M West, PhD, RN
- Номер телефона: 517-432-8356
- Электронная почта: westpatr@msu.edu
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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:
-
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Physical Activity
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility of Intervention
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Patricia M West, PhD, RN, Michigan State University
Публикации и полезные ссылки
Общие публикации
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Rodgers WM, Wilson PM, Hall CR, Fraser SN, Murray TC. Evidence for a multidimensional self-efficacy for exercise scale. Res Q Exerc Sport. 2008 Jun;79(2):222-34. doi: 10.1080/02701367.2008.10599485.
- Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
- Hartley SL, MacLean WE Jr. A review of the reliability and validity of Likert-type scales for people with intellectual disability. J Intellect Disabil Res. 2006 Nov;50(Pt 11):813-27. doi: 10.1111/j.1365-2788.2006.00844.x.
- Qian J, McDonough DJ, Gao Z. The Effectiveness of Virtual Reality Exercise on Individual's Physiological, Psychological and Rehabilitative Outcomes: A Systematic Review. Int J Environ Res Public Health. 2020 Jun 10;17(11):4133. doi: 10.3390/ijerph17114133.
- Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6.
- McDermott S, Royer J, Cope T, Lindgren S, Momany E, Lee JC, McDuffie MJ, Lauer E, Kurtz S, Armour BS. Using Medicaid Data to Characterize Persons With Intellectual and Developmental Disabilities in Five U.S. States. Am J Intellect Dev Disabil. 2018 Jul;123(4):371-381. doi: 10.1352/1944-7558-123.4.371.
- Mesa-Gresa P, Gil-Gomez H, Lozano-Quilis JA, Gil-Gomez JA. Effectiveness of Virtual Reality for Children and Adolescents with Autism Spectrum Disorder: An Evidence-Based Systematic Review. Sensors (Basel). 2018 Aug 1;18(8):2486. doi: 10.3390/s18082486.
- Iezzoni LI, Rao SR, Ressalam J, Bolcic-Jankovic D, Agaronnik ND, Donelan K, Lagu T, Campbell EG. Physicians' Perceptions Of People With Disability And Their Health Care. Health Aff (Millwood). 2021 Feb;40(2):297-306. doi: 10.1377/hlthaff.2020.01452.
- Charlier N, Zupancic N, Fieuws S, Denhaerynck K, Zaman B, Moons P. Serious games for improving knowledge and self-management in young people with chronic conditions: a systematic review and meta-analysis. J Am Med Inform Assoc. 2016 Jan;23(1):230-9. doi: 10.1093/jamia/ocv100. Epub 2015 Jul 17.
- Mammen JR, Java JJ, Rhee H, Butz AM, Halterman JS, Arcoleo K. Mixed-methods content and sentiment analysis of adolescents' voice diaries describing daily experiences with asthma and self-management decision-making. Clin Exp Allergy. 2019 Mar;49(3):299-307. doi: 10.1111/cea.13250. Epub 2018 Sep 18.
- Mammen JR, McGovern CM, Schoonmaker JD, Philibert A, Schlegel EC, Arcoleo K. A multilevel perspective on goals, barriers, and facilitators of school-based asthma management. J Asthma. 2022 Dec;59(12):2461-2474. doi: 10.1080/02770903.2021.2018704. Epub 2021 Dec 28.
- Arcoleo K, Zayas LE, Hawthorne A, Begay R. Illness representations and cultural practices play a role in patient-centered care in childhood asthma: experiences of Mexican mothers. J Asthma. 2015 Sep;52(7):699-706. doi: 10.3109/02770903.2014.1001905. Epub 2015 Mar 10.
- Hauck, J., Fisher, M., & West, P. (2024-2025). Health and the Role of Employment Among Young Adults with Intellectual and Developmental Disabilities [Grant]. Michigan State University Research Foundation and TETRAD Program. https://research.msu.edu/news/tetrad-awards-announced-2024
- Mirza M, Brown-Hollie JP, Suarez-Balcazar Y, Parra-Medina D, Camillone S, Zeng W, Garcia-Gomez E, Heydarian N, Magana S. Interventions for Health Promotion and Obesity Prevention for Children and Adolescents with Developmental Disabilities: a Systematic Review. Rev J Autism Dev Disord. 2022 Aug 22:1-24. doi: 10.1007/s40489-022-00335-5. Online ahead of print.
- Bandini L, Danielson M, Esposito LE, Foley JT, Fox MH, Frey GC, Fleming RK, Krahn G, Must A, Porretta DL, Rodgers AB, Stanish H, Urv T, Vogel LC, Humphries K. Obesity in children with developmental and/or physical disabilities. Disabil Health J. 2015 Jul;8(3):309-16. doi: 10.1016/j.dhjo.2015.04.005. Epub 2015 May 7.
- Saure E, Castren M, Mikkola K, Salmi J. Intellectual disabilities moderate sex/gender differences in autism spectrum disorder: a systematic review and meta-analysis. J Intellect Disabil Res. 2023 Jan;67(1):1-34. doi: 10.1111/jir.12989. Epub 2022 Nov 29.
- Polyak A, Rosenfeld JA, Girirajan S. An assessment of sex bias in neurodevelopmental disorders. Genome Med. 2015 Aug 27;7(1):94. doi: 10.1186/s13073-015-0216-5.
- Yu S, Wang T, Zhong T, Qian Y, Qi J. Barriers and Facilitators of Physical Activity Participation among Children and Adolescents with Intellectual Disabilities: A Scoping Review. Healthcare (Basel). 2022 Jan 26;10(2):233. doi: 10.3390/healthcare10020233.
- Zimet, G.D., Dahlem, N.W, Zimet, S.G., & Farley, G.K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2
- Pett MA, Guo JW, Cardell B, Johnson EP, Guerra N, Clark L. Psychometric properties of a brief self-reported health-related quality of life measure (HRQoL-IDD) for persons with intellectual and developmental disabilities. J Appl Res Intellect Disabil. 2021 May;34(3):877-890. doi: 10.1111/jar.12831. Epub 2021 Jan 31.
- Holmes HM, Mortenson WB. What makes life better or worse: Quality of life according to people with intellectual disabilities. J Appl Res Intellect Disabil. 2024 Sep;37(5):e13280. doi: 10.1111/jar.13280.
- Light J, McNaughton D, Caron J. New and emerging AAC technology supports for children with complex communication needs and their communication partners: State of the science and future research directions. Augment Altern Commun. 2019 Mar;35(1):26-41. doi: 10.1080/07434618.2018.1557251. Epub 2019 Jan 16.
- Vagel, M.D. (2016). Data gathering and analysis in crafting phenomenological research. Routledge.
- American Association on Intellectual and Developmental Disabilities (2023) Defining criteria for intellectual disability. Available at: https://www.aaidd.org/intellectual-disability/definition
- National Center for Education Statistics (2023) Students with disabilities: condition of education. U.S. Department of Education, Institute of Education Sciences. Available at: https://nces.ed.gov/programs/coe/indicator/cgg (Accessed: 1 February 2024).
- World Health Organization [WHO]. (2024). Global levels of physical inactivity in adults: Off track for 2030. https://www.who.int/publications/i/item/9789240096905
- National Institute of Nursing Research [NINR]. (2024). Scientific strategy: NINR's research framework. https://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan/research-framework
- Vetter NS, Ilskens K, Seidl N, Latteck AD, Bruland D. Health Literacy of People with Intellectual Disabilities: How Meaningful Is the Social Context for a Target Group-Oriented Model of Health Literacy? Int J Environ Res Public Health. 2022 Nov 30;19(23):16052. doi: 10.3390/ijerph192316052.
- Braddock D, Hemp R, Tanis ES, Wu J, Haffer L. (2017). The state of the states in intellectual and developmental disabilities.11th ed. Washington, DC: The American Association on Intellectual and Developmental Disabilities.
- Physical Activity Alliance. (2024). The 2024 United States report card on physical activity for children and youth. https://paamovewithus.org/wp-content/uploads/2024/10/2024-U.S.-Report-Card-on-Physical-Activity-for-Children-and-Youth.pdf
- Friedman, C. & Spassiani, N.A. (2024). Making survey research accessible for people with intellectual and developmental disabilities. In: Bennett, G., Goodall, E. (eds) The Palgrave Encyclopedia of Disability. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-031-40858-8_77-1
- Pitchford EA, Dixon-Ibarra A, Hauck JL. Physical Activity Research in Intellectual Disability: A Scoping Review Using the Behavioral Epidemiological Framework. Am J Intellect Dev Disabil. 2018 Mar;123(2):140-163. doi: 10.1352/1944-7558-123.2.140.
- Di Lorito C, Bosco A, Birt L, Hassiotis A. Co-research with adults with intellectual disability: A systematic review. J Appl Res Intellect Disabil. 2018 Sep;31(5):669-686. doi: 10.1111/jar.12435. Epub 2017 Dec 12.
- Shields N, Synnot AJ, Barr M. Perceived barriers and facilitators to physical activity for children with disability: a systematic review. Br J Sports Med. 2012 Nov;46(14):989-97. doi: 10.1136/bjsports-2011-090236. Epub 2011 Sep 26.
- McGarty AM, Melville CA. Parental perceptions of facilitators and barriers to physical activity for children with intellectual disabilities: A mixed methods systematic review. Res Dev Disabil. 2018 Feb;73:40-57. doi: 10.1016/j.ridd.2017.12.007. Epub 2017 Dec 14.
- Lieberman DA, Chamberlin B, Medina E Jr, Franklin BA, Sanner BM, Vafiadis DK; Power of Play: Innovations in Getting Active Summit Planning Committee. The power of play: Innovations in Getting Active Summit 2011: a science panel proceedings report from the American Heart Association. Circulation. 2011 May 31;123(21):2507-16. doi: 10.1161/CIR.0b013e318219661d. Epub 2011 Apr 25.
- McMahon, A.K. & McMahon, D.D. (2016). Exercise technology interventions and individuals with IDD. Division of Autism and Developmental Disabilities Online Journal, 3, 42-53.
- Sandjojo J, Zedlitz AMEE, Gebhardt WA, Hoekman J, den Haan JA, Evers AWM. Effects of a self-management training for people with intellectual disabilities. J Appl Res Intellect Disabil. 2019 Mar;32(2):390-400. doi: 10.1111/jar.12536. Epub 2018 Oct 23.
- Centers for Disease Control and Prevention [CDC]. (2014). Key findings: Prevalence and impact of unhealthy weight in a national sample of US adolescents with autism and other learning and behavioral disorders. https://www.cdc.gov/ncbddd/autism/features/keyfindings-unhealthy-weight.html
- O'Leary L, Cooper SA, Hughes-McCormack L. Early death and causes of death of people with intellectual disabilities: A systematic review. J Appl Res Intellect Disabil. 2018 May;31(3):325-342. doi: 10.1111/jar.12417. Epub 2017 Oct 6.
- McGarty AM, Downs SJ, Melville CA, Harris L. A systematic review and meta-analysis of interventions to increase physical activity in children and adolescents with intellectual disabilities. J Intellect Disabil Res. 2018 Apr;62(4):312-329. doi: 10.1111/jir.12467. Epub 2017 Dec 26.
- Ailey SH, Bathje M, Ticha R, Abery B, Khuu BK, Angel L. Health professionals' education related to people with intellectual and developmental disabilities: A scoping review. J Appl Res Intellect Disabil. 2024 May;37(3):e13208. doi: 10.1111/jar.13208.
- Centers for Disease Control and Prevention. (2023). Disability impacts all of us. https://www.cdc.gov/ncbddd/disabilityandhealth/infographic-disability-impacts-all.html
- Valdez RS, Swenor BK. Structural Ableism - Essential Steps for Abolishing Disability Injustice. N Engl J Med. 2023 May 18;388(20):1827-1829. doi: 10.1056/NEJMp2302561. Epub 2023 May 13. No abstract available.
- Centers for Disease Control and Prevention. (2022). Equitable and inclusive access. https://www.cdc.gov/physicalactivity/community-strategies/equitable-and-inclusive-access.html
- National Institute on Minority Health and Health Disparities [NIMHD]. (2023). National Advisory Council on Minority Health and Health Disparities (NACMHD) working group on persons living with disabilities. https://nimhd.nih.gov/docs/advisory-council/nacmhd_workGrpOnHealthDisparitiesAndPeopleWithDisabilities_report_2023sept.pdf
- National Council on Disability (2023). Framework to end health disparities of people with disabilities. https://www.ncd.gov/report/framework-to-end-health-disparities-of-people-with-disabilities/
- Friedman, C. (2024) Disparities in social Determinants of health amongst people with disabilities. International Journal of Disability, Development and Education, 71(1), 101-117. https://doi.org/10.1080/1034912X.2021.2004299
- Rimmer JH. Addressing Disability Inequities: Let's Stop Admiring the Problem and Do Something about It. Int J Environ Res Public Health. 2022 Sep 20;19(19):11886. doi: 10.3390/ijerph191911886.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY202600294
- 1K01NR022135-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .