Physical ActivityNCT05149443
Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability
A study testing theory-based mHealth-intervention (app) in people with Physical Activity and Health Promotion, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Promotion, Adolescents
- What is being tested?
- theory-based mHealth-intervention (app)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Adolescents with moderate, severe or profound ID
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Move it, Move ID! A Co-created and Theory-based mHealth Intervention to Increase Physical Activity in Adolescents With Intellectual Disability
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.
Read the 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.
- Being tested
- theory-based mHealth-intervention (app)
- Medical subject headings
- Motor Activity, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theory-based mHealth-intervention (app)Behavioural
Also called Component 1 (buddy)
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.
theory-based mHealth-intervention (app)Behavioural
Also called Component 1+2 (buddy+gamification)
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.
| Study group | Role | What they receive |
|---|---|---|
| Effectiveness of the Move it, Move ID app | Experimental | All participants will receive the Move it, Move ID app. Receives: Behavioral: theory-based mHealth-intervention (app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 32 days (post-test)
Secondary outcomes (1)
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).
Measured: 32 days (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149443
- Sponsor's protocol ID
- FWO/11F3621N
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move it, Move ID! A Co-created and Theory-based mHealth Intervention to Increase Physical Activity in Adolescents With Intellectual Disability
- ClinicalTrials.gov ID
- NCT05149443
- Acronym / sponsor ID
- FWO/11F3621N
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Effectiveness of the Move it, Move ID app | Experimental | Behavioral: theory-based mHealth-intervention (app)All participants will receive the Move it, Move ID app. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Adolescents with moderate, severe or profound ID
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theory-based mHealth-intervention (app)Also: Component 1 (buddy)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. | Behavioural | Effectiveness of the Move it, Move ID app |
| theory-based mHealth-intervention (app)Also: Component 1+2 (buddy+gamification)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. | Behavioural | Effectiveness of the Move it, Move ID app |
Primary outcome
Physical Activity
Time frame: 32 days (post-test)
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.
1 secondary outcome
Engagement (with the app)
Time frame: 32 days (post-test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theory-based mHealth-intervention (app) in people with Physical Activity and Health Promotion, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 32 days (post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.