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Clinical Trials/NCT04929106
NCT04929106
Completed
N/A

Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study

University Hospital of North Norway1 site in 1 country9 target enrollmentMay 7, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intellectual Disability
Sponsor
University Hospital of North Norway
Enrollment
9
Locations
1
Primary Endpoint
Changes in steps per day
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2021
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Changes in steps per day

Time Frame: Baseline, 4 weeks, 12 weeks

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.

Secondary Outcomes

  • Behavioral problems(Baseline, 4 weeks, 12 weeks)
  • Minutes of moderate physical acitivty(Baseline, 4 weeks, 12 weeks)
  • Physical activity levels(Baseline, 4 weeks, 12 weeks)
  • Satisfaction with life(Baseline, 4 weeks, 12 weeks)
  • Social support for physical activity and self-efficacy in a physical activity setting(Baseline, 4 weeks, 12 weeks)
  • Goal Attainment(Introduced together with intervention, 1 week after baseline)

Study Sites (1)

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