Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability
Primary Purpose
Physical Activity, Health Promotion, Adolescents
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
theory-based mHealth-intervention (app)
theory-based mHealth-intervention (app)
Sponsored by
About this trial
This is an interventional other trial for Physical Activity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Adolescents with moderate, severe or profound ID
Sites / Locations
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Effectiveness of the Move it, Move ID app
Arm Description
All participants will receive the Move it, Move ID app.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Engagement (with the app)
Engagement will be measured through the use of subjective and objective measures. Experiential engagement will be assessed using the User Engagement Scale Short Form (UES-SF). Items will be assessed after the B2 intervention phase. In case of difficulties with literacy, buddies will be asked to help the participants fill in the questionnaire. However, research among people with ID shows that Likert scales are easily understood and meaningful to the respondents. In addition, individual semi-structured interviews (e.g.
immediately post-intervention, so after B2) will be conducted to learn more about users' experiences of the intervention components. Behavioural engagement will be assessed via objective measures (usage data). A log data analysis will be conducted to track use patterns, including number of logins, their time spent online and the moment that a participant stops using the application (e.g. drop-out).
Full Information
NCT ID
NCT05149443
First Posted
November 24, 2021
Last Updated
November 7, 2022
Sponsor
University Ghent
Collaborators
Research Foundation Flanders
1. Study Identification
Unique Protocol Identification Number
NCT05149443
Brief Title
Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability
Official Title
Move it, Move ID! A Co-created and Theory-based mHealth Intervention to Increase Physical Activity in Adolescents With Intellectual Disability
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Research Foundation Flanders
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Overweight and obesity are globally challenging health problems and major risk factors for a number of chronic diseases, including diabetes, cardiovascular diseases and cancer. Sufficient physical activity (PA) is an important protective factor in the development of overweight and obesity. Adolescents with intellectual disability (ID) report lower levels of PA and higher rates of overweight and obesity in comparison to adolescents without ID. There is a dire need to find ways to promote PA in adolescents with ID for their present and future health. However, while PA promotion in adolescents is a welldeveloped science, there is only a handful of studies dedicated to adolescents with ID. Consequently developing and designing PA promotion interventions specifically tailored to the needs of youth with ID is of the utmost importance. Currently, however, there is a real knowledge gap in terms of fundamental research on crucial intervention mechanisms to promote PA in adolescents with ID, as well as specific behaviour change theories adapted to this population. The aim of the current research project is to co-create and evaluate a theory-based mHealth intervention, which focuses on increasing PA for adolescents with ID.
The underlying framework within the intervention development is the Behaviour Change Wheel, together with a co-creation approach which is a bottom-up approach in which the target group (adolescents with ID in this case) is actively involved in the development of the intervention. The result of this approach is contextually appropriate intervention and intervention strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Health Promotion, Adolescents, Intellectual Disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Effectiveness of the Move it, Move ID app
Arm Type
Experimental
Arm Description
All participants will receive the Move it, Move ID app.
Intervention Type
Behavioral
Intervention Name(s)
theory-based mHealth-intervention (app)
Other Intervention Name(s)
Component 1 (buddy)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
theory-based mHealth-intervention (app)
Other Intervention Name(s)
Component 1+2 (buddy+gamification)
Intervention Description
After the first study, other participants will be recruited. In a second study, the set-up remains the same, but the A1 and A2 phase this time consist of the buddy component (i.e. control phase) and in the B1 and B2 phase the gamification component will be added. This way, we can determine whether the gamification component has an effect on PA compared to the baseline buddy component intervention.
The study duration is 32 days for all participants. The duration of the 4 different phases of the design will vary between participants, but each phase will have a duration of minimum 5 days.
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
32 days (post-test)
Secondary Outcome Measure Information:
Title
Engagement (with the app)
Description
Engagement will be measured through the use of subjective and objective measures. Experiential engagement will be assessed using the User Engagement Scale Short Form (UES-SF). Items will be assessed after the B2 intervention phase. In case of difficulties with literacy, buddies will be asked to help the participants fill in the questionnaire. However, research among people with ID shows that Likert scales are easily understood and meaningful to the respondents. In addition, individual semi-structured interviews (e.g.
immediately post-intervention, so after B2) will be conducted to learn more about users' experiences of the intervention components. Behavioural engagement will be assessed via objective measures (usage data). A log data analysis will be conducted to track use patterns, including number of logins, their time spent online and the moment that a participant stops using the application (e.g. drop-out).
Time Frame
32 days (post-test)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Adolescents with moderate, severe or profound ID
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Maenhout
Phone
+3292646321
Email
laura.maenhout@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Greet Cardon
Phone
+32 9 264.91.42.
Email
Greet.Cardon@UGent.be
Facility Information:
Facility Name
Ghent University
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability
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