Physical Activity, mHealth and Intellectual Disability - a Pilot Study

NCT04929106 | Completed DMC

• 1 other identifier: 2016/1770
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Intellectual Disability

Keywords

Intellectual Disability; Physical Activity; Technology; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Minutes of moderate physical acitivty

  Baseline, 4 weeks, 12 weeks

• Physical activity levels

  Baseline, 4 weeks, 12 weeks

• Behavioral problems

  Baseline, 4 weeks, 12 weeks

• Social support for physical activity and self-efficacy in a physical activity setting

  Baseline, 4 weeks, 12 weeks

• Satisfaction with life

  Baseline, 4 weeks, 12 weeks

Study Arms (1)

MHealth intervention

EXPERIMENTAL

Tailored physical activity program with motivational mobile health support on everyday levels of physical activity

Device: mHealth support tool

Interventions

mHealth support tool DEVICE

The final app is named Active Leisure and consists of an advanced activity planner based on the platform developed by the ideal company Smart Cognition AS. The app offers different interface options (symbols only, easy to read text, plain text, and read aloud). The activity planner will mostly be used by the individual with IDs and a support person (caregiver or health care provider). After completing an activity, a simple reward is available (e.g., a smiling face or to share a picture with other users of the app). The use of tailored communication through personalization: the use of individuals first name in the activity planner, adaptation: individually chosen activities, adjusted communication (symbols, easy-to-read text or plain text), preparation and planning, and feedback: rewarding and positive feedback (after activities have been performed) is expected to increase motivation, and thereby lead to higher levels of PA.

MHealth intervention

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (3)

• 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.

  PMID: 32437328 BACKGROUND

• 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.

  PMID: 31981261 RESULT

• 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.

  PMID: 36107473 DERIVED

MeSH Terms

Conditions

Intellectual Disability; Motor Activity

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Audny Anke, Prof. MD

  University Hospital of North Norway, UiT Artic University of Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: May 7, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 10, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)