Intellectual Disability Clinical Trial
Official title:
Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study
NCT number | NCT04929106 |
Other study ID # | 2016/1770 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2021 |
Est. completion date | June 1, 2022 |
Verified date | June 2021 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this pilot study is to assess distant procedures, study experiences and feasibility of a planned randomized controlled trial investigating the use of a mHealth support tool on physical activity for individuals with intellectual disability.
Status | Completed |
Enrollment | 9 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility | Inclusion Criteria: - Low physical activity levels: determined with the question "How much of your leisure time have you been physically active in the last year?" - Diagnosis of intellectual disability (mild, moderate, severe, or profound) - Aged 16-60 years old - Ability to participate in the intervention - Ability to walk with or without support - Able to provide written informed consent or written informed consent can be obtained from a representative Exclusion Criteria: - Medical contraindications for participation in programs with increased exercise, as advised by the primary care or ID specialist physician - High level of physical activity - Inability to provide written informed consent and written informed consent cannot be obtained from a representative |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | The Royal Norwegian Ministry of Health |
Norway,
Michalsen H, Wangberg SC, Anke A, Hartvigsen G, Jaccheri L, Arntzen C. Family members and health care workers' perspectives on motivational factors of participation in physical activity for people with intellectual disability: A qualitative study. J Intel — View Citation
Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in steps per day | Objectively measured physical activity assessed by steps per day measured with a wrist-worn commercial accelerometer (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA). The device will assess level of physical activity and sedentary time. The watch will show a neutral screen during baseline and follow-up assessments. Level of physical activity will be measured for 7 days at each assessment, with a minimum of 3 consecutive days of measurement because previous research has shown that 3 days of physical activity can predict weekly level of physical activity. | Baseline, 4 weeks, 12 weeks | |
Secondary | Minutes of moderate physical acitivty | Secondary PA outcomes are minutes of moderate PA per day measured with a wrist-worn commercial fitness tracker (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA). | Baseline, 4 weeks, 12 weeks | |
Secondary | Physical activity levels | The International Physical Activity Questionnaire - Short Form, adapted to measure physical activity using proxy respondents will be used. The International Physical Activity Questionnaire - Short Form is a 7-item questionnaire that assesses PA in the past 7 days at 4 intensity levels: 1) vigorous-intensity activity, such as aerobics, 2) moderate-intensity activity, such as leisure cycling, 3) walking, and 4) sitting. | Baseline, 4 weeks, 12 weeks | |
Secondary | Behavioral problems | The Aberrant Behavior Checklist-Community (ABC-C) is a questionnaire designed to assess challenging behavior in children, youth, and adults with IDs. The checklist consist of 58 items divided into 5 subscales: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. It is a proxy measure requiring knowledge of the person with ID. Each item is scored on a scale of 0-3 (3 indicating the most severity). The questionnaire has been validated for use in a Norwegian population with neurodevelopmental disabilities. | Baseline, 4 weeks, 12 weeks | |
Secondary | Social support for physical activity and self-efficacy in a physical activity setting | The Self-Efficacy/Social Support for Activity for persons with Intellectual Disability scale (SE/SS-AID) is a questionnaire consisting of four subscales. One subscale measures self-efficacy for overcoming barriers to leisure physical activity. The last three subscales measure social support for leisure activity from family members, care staff, and friends for individuals with intellectual disabilities. The scale has been validated for self-reporting from individuals with mild to moderate intellectual disability and for use by proxy respondents. The questionnaire will be translated into the Norwegian language using standard guidelines. | Baseline, 4 weeks, 12 weeks | |
Secondary | Satisfaction with life | This study will use the satisfaction with life scale developed by Bergström & Hochwälder, which was designed to assess satisfaction with the home environment and leisure time in individuals with mild to moderate intellectual disability. The scale has four factors: 1) satisfaction with housing environment, 2) satisfaction with life, 3) satisfaction with meals, and 4) satisfaction with recreational activities. Items are read aloud by a researcher and answered by participants with three response options: "good" (happy face = 2), "in between" (neutral face = 1), or "bad" (sad face = 0). In the current study, the scale is used to control for adverse effects. | Baseline, 4 weeks, 12 weeks | |
Secondary | Goal Attainment | Goal attainment scaling will be used to identify self-management goals that participants would like to achieve. The questionnaire will be filled out by the researcher, with participants and proxy respondents present. Goal attainment scaling involves several steps. Goals are selected by each individual, and observable behavior that reflects a degree of goal attainment is defined. The participant's pre-treatment or baseline levels are defined in terms of the goal. Five different goal attainment levels are used, ranging from "no change" to "much better than expected outcome" (numbered -2 to +2). Follow-up times for participant evaluation are set (presumably after 3 and 6 months). Goal attainment is evaluated after the defined time interval. At the end, the overall attainment score for all goals are calculated. In this study we will define up to three goals for PA. | Introduced together with intervention, 1 week after baseline |
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