Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability

NCT05149443 | Completed

• 1 other identifier: FWO/11F3621N
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop and implement an mHealth intervention focusing on the promotion of physical activity in adolescents with intellectual disability.

Conditions

Physical Activity; Health Promotion; Adolescents; Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  The primary outcome of the intervention is PA. To objectively measure PA, participants will be asked to wear an accelerometer (e.g., Axivity AX3). The purpose of buddies wearing an Axivity is to be able to explain effects afterwards regarding whether or not having a cooperating buddy during the intervention period. The Axivity will be worn on the wrist and is waterproof. As such, participants do not have to remove the Axivity during the intervention period countering the issue of non-wear.

  32 days (post-test)

Secondary Outcomes (1)

• Engagement (with the app)

  32 days (post-test)

Study Arms (1)

Effectiveness of the Move it, Move ID app

EXPERIMENTAL

All participants will receive the Move it, Move ID app.

Behavioral: theory-based mHealth-intervention (app)

Interventions

theory-based mHealth-intervention (app) BEHAVIORAL

Measuring the effect of the buddy and gamification components separately. During the A1 phase (baseline) and the A2 phase (reversal), participants will be asked not to use the 'Move it, Move ID' intervention: the app will be blocked. After an A phase, the app will be unblocked. During the B1 and B2 intervention phase, participants use the 'Move My it, Move ID' intervention only consisting of the buddycomponent. During the intervention period, adolescents and buddies are asked to wear an accelerometer. During the first AB pair we examine whether the buddy component has an effect on PA compared to no intervention. In the A2 reversal phase possible carryover effects can be measured. It will be informative to investigate whether some parts of the intervention are automatized or internalized and will still have some effect even when participants have no access to the intervention anymore (i.e. A2 phase). The study duration is 32 days; each phase will have a duration of minimum 5 days.

Also known as: Component 1 (buddy)

Effectiveness of the Move it, Move ID app

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents with mild ID
• Dutch speaking
• Having a smartphone or tablet (or being able to use a test smartphone from the research group)
• Having enough motor skills to engage in PA

You may not qualify if:

• Adolescents with moderate, severe or profound ID

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Ghent University

Ghent, Belgium

Location

MeSH Terms

Conditions

Motor Activity; Intellectual Disability

Interventions

Amyloid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

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

Model Details: The effectiveness of the 'Move it, Move ID'-intervention and its two different components (i.e. buddy and gamification) will be measured through an aggregated single case design, i.e. the ABAB reversal design. Rather than taking few measurements from a sample of many individuals, many measurements are taken repeatedly from the same individual(s) in ABAB reversal designs. Participants are serving as their own controls, leading to the fact that overall sample sizes are smaller than traditional RCTs without losing adequate power.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

BE (1)