Clinical trial NCT04929106: Physical Activity, mHealth and Intellectual Disability - a Pilot Study
Official title: Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: Intellectual Disability
Physical Activity
Technology
mHealth
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2021-06-18
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: For individuals with intellectual disability (ID) with low physical activity (PA) levels, new methods to increase participation in physical activity are needed. Motivation for participation in PA should include both individuals with ID, family members and staff, and it should work in a supportive way to strengthen mastery experiences. Technology-based interventions have not yet been explored extensively.

The study objective is to assess feasibility of procedures for a distant, COVID-19-secure intervention, study pre-treatment expectations and experiences of participants and their caregivers. In addition, the study will explore the effectiveness of an individually tailored PA program with motivational mobile health support on everyday levels of PA, goal setting and self-efficacy in a PA setting for youth and adults with intellectual disabilities.

The current protocol concerns the conducting of a mixed method pilot study to test intervention procedures of a planned complex randomised controlled trial, with steps per day as main outcome. Ten participants with intellectual disability are included. Assessment are at baseline, follow-up after 4 weeks and 12 weeks. Goal attainment scale will be used together with the introduction of an activity planner application named Active Leisure as the intervention. Feasibility and acceptance of procedures, activity measures and questionnaires are assessed.

The present trial will investigate how modern technology and e-health can be used in the promotion of PA in individuals with IDs. The study has potentially important implications for both individuals with IDs and their support networks. If successful, the project will provide a simple and accessible solution for promoting PA in individuals with IDs.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in steps per day
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Minutes of moderate physical acitivty
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Physical activity levels
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Behavioral problems
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Social support for physical activity and self-efficacy in a physical activity setting
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Satisfaction with life
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Goal Attainment
timeFrame: Introduced together with intervention, 1 week after baseline
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway, UiT Artic University of Norway
name: Audny Anke, Prof. MD
role: STUDY_DIRECTOR
References:
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.
citation: 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 Intellect Disabil Res. 2020 Apr;64(4):259-270. doi: 10.1111/jir.12716. Epub 2020 Jan 24.
citation: Michalsen H, Wangberg SC, Hartvigsen G, Henriksen A, Pettersen G, Jaccheri L, Jahnsen RB, Thrane G, Arntzen C, Anke A. mHealth Support to Stimulate Physical Activity in Individuals With Intellectual Disability: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2022 Sep 15;11(9):e37849. doi: 10.2196/37849.