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Clinical Trials/NCT04079439
NCT04079439
Terminated
Not Applicable

Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial

University Hospital of North Norway1 site in 1 country60 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual Disability
Sponsor
University Hospital of North Norway
Enrollment
60
Locations
1
Primary Endpoint
Steps per day
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
January 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Steps per day

Time Frame: Baseline, 3 months and 6 months

The primary outcome is physical activity, objectively assessed by steps per day measured with an accelerometer. This will objectively assess physical activity and sedentary time. Change in steps per day is being assessed at baseline, after three months of intervention and after 6 months of intervention.

Secondary Outcomes

  • Waist Circumference(Baseline, 3 months and 6 months)
  • Goalsetting(Baseline, 3 months and 6 months)
  • Physical activity(Baseline, 3 months and 6 months)
  • Challenging behaviour(Baseline, 3 months and 6 months)
  • Social network(Baseline, 3 months and 6 months)
  • Blood pressure(Baseline, 3 months and 6 months)
  • Physical functioning(Baseline, 3 months and 6 months)
  • Body Mass Index (BMI)(Baseline, 3 months and 6 months)
  • Satisfaction with life(Baseline, 3 months and 6 months)
  • Self-efficacy and social support(Baseline, 3 months and 6 months)

Study Sites (1)

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