Clinical trial NCT04079439: Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability
Official title: Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intellectual Disability
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed randomised controlled study
Primary purpose: OTHER

Brief summary: The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

Detailed description: Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.

The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.

The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.

The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.

Eligibility criteria: Inclusion Criteria:

* Intellectual disability
* Age 15-60 years
* Low physical activity
* Sedentary lifestyle

Exclusion Criteria:

* Medical contradictions for participation
* High levels of physical activity

Primary outcomes:
measure: Steps per day
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Blood pressure
timeFrame: Baseline, 3 months and 6 months
measure: Waist Circumference
timeFrame: Baseline, 3 months and 6 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3 months and 6 months
measure: Physical functioning
timeFrame: Baseline, 3 months and 6 months
measure: Self-efficacy and social support
timeFrame: Baseline, 3 months and 6 months
measure: Challenging behaviour
timeFrame: Baseline, 3 months and 6 months
measure: Satisfaction with life
timeFrame: Baseline, 3 months and 6 months
measure: Social network
timeFrame: Baseline, 3 months and 6 months
measure: Goalsetting
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Audny Anke, Professor
role: PRINCIPAL_INVESTIGATOR
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.