Physical ActivityNCT03783611
Effectiveness of MyPlan 2.0. in Older Adults
A study testing MyPlan 2.0. in people with Physical Activity and Older Adults, run by University Ghent.
Trial summary
The beneficial effects of physical activity (PA) for older adults are well known. Yet, few older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth interventions are effective in raising PA levels in older adults on the short-term. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Older Adults
- What is being tested?
- MyPlan 2.0.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2016to 16 Jun 2017
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- retired
- able to walk 100 meters without assistance
- speak and understand Dutch
- have an email address
Who cannot join
- severe physical health problems
- not retired
- not able to speak and understand Dutch
- not having an email address
About this study
Official title: Testing the Effectiveness of MyPlan 2.0. on Physical Activity in Older Adults
The beneficial effects of physical activity (PA) for older adults are well known. Yet, few older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth interventions are effective in raising PA levels in older adults on the short-term. However, intermediate- or long-term effects have been examined rarely. This study aimed to investigate the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and self-reported PA levels in Belgian older adults on the short- and intermediate-term.
This study was a randomized controlled trial with three measurement moments (baseline (n=72), post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At all measurement moments, participants in the control group and intervention group filled out the International Physical Activity Questionnaire and wore an accelerometer during one week. Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0' and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on self-regulatory theory and focused on both pre- and post-intentional processes to increase PA.
Read the detailed description
Technical information about the content of the MyPlan 2.0. intervention:
MyPlan 2.0. was the eHealth intervention that was used in this study. MyPlan 2.0. is a theory- and user-based intervention. Theories used to develop the intervention are the self-regulation theory and the Health Action Approach model. The intervention targets pre- and post-intentional processes to reach behavior change. The intervention consists of five website visits in five weeks (one per week).
During the first website visit, the participants fill in a short PA questionnaire and based on the answers, they receive personal feedback about their behavior (pre-intentional processes). Knowledge is also provided by giving users the chance to fill in an optional quiz about PA and its beneficial effects. Post-intentional processes are targeted during this first visit by asking the participants to make an action plan. Participants are asked what they want to do (e.g. being more active by cycling during leisure time), when (e.g. every Sunday morning), where (e.g. in the streets nearby) and for how long (e.g. 60 minutes). After answering these questions, the participants can identify difficult situations and possible barriers (i.e. coping planning) while pursuing their goals. Dependent on which barriers they select, specific solutions are given and the participants could choose which ones they consider appropriate and want to apply. After this first website visit, the users can indicate how they want to self-monitor their behaviour (e.g. using an agenda).
One week after finishing the first website visit, the participants receive an email to revisit the website. During this second visit, they receive feedback about their behavioural change process and their goals (e.g. did the participant reach his/her goal or not?). Afterwards the participants have the possibility to adapt their action plan (e.g. setting new, more realistic goals). They can reconsider coping plans, based on barriers they experienced while pursuing their goals. Furthermore, participants can optionally read activity tips. Website visits 3, 4 and 5 are respectively activated one week after the previous visit. Again, the participants are reminded by email. These three last visits are identical to the second visit (review of the action and coping plan).
- Conditions
- Physical Activity, Older Adults
- Being tested
- MyPlan 2.0.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPlan 2.0.Behavioural
eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group has access to the MyPlan 2.0. eHealth intervention. MyPlan is a eHealth intervention designed to increase physical activity. The intervention is based on the self-regulation theory and focuses on pre- and post-intentional processes to increase physical activity. Receives: Behavioral: MyPlan 2.0. |
| control group | No intervention | The control group receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in accelerometer-based physical activity
participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity.
Measured: change between baseline and post (5 weeks after baseline)
change in accelerometer-based physical activity
participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity.
Measured: change between baseline and follow-up (3 months after baseline)
change in self-reported physical activity
the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
Measured: change between baseline and post (5 weeks after baseline)
change in self-reported physical activity
the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
Measured: change between baseline and follow-up (3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start7 Nov 2016
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vakgroepsport, University Ghent
- Investigators
- Greet Cardon, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783611
- Sponsor's protocol ID
- MyPlan2.0._olderadults
- Status last verified
- May 2019
- First submitted
- 12 Dec 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only researchers of our own research group will have access to the full data of the participants, only for research purposes. Only anonymized data will be shared with other researchers of our own research group. other researchers can obtain research information upon request
Publications
Van Dyck D, Herman K, Poppe L, Crombez G, De Bourdeaudhuij I, Gheysen F. Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 7;21(10):e13219. doi: 10.2196/13219.
PubMed 31593541
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of MyPlan 2.0. on Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT03783611
- Acronym / sponsor ID
- MyPlan2.0._olderadults
- Conditions
- Physical Activity, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 21 Dec 2018 (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 beneficial effects of physical activity (PA) for older adults are well known. Yet, few older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth interventions are effective in raising PA levels in older adults on the short-term. However, intermediate- or long-term effects have been examined rarely. This study aimed to investigate the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and self-reported PA levels in Belgian older adults on the short- and intermediate-term.
This study was a randomized controlled trial with three measurement moments (baseline (n=72), post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At all measurement moments, participants in the control group and intervention group filled out the International Physical Activity Questionnaire and wore an accelerometer during one week. Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0' and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on self-regulatory theory and focused on both pre- and post-intentional processes to increase PA.
Detailed description
Technical information about the content of the MyPlan 2.0. intervention:
MyPlan 2.0. was the eHealth intervention that was used in this study. MyPlan 2.0. is a theory- and user-based intervention. Theories used to develop the intervention are the self-regulation theory and the Health Action Approach model. The intervention targets pre- and post-intentional processes to reach behavior change. The intervention consists of five website visits in five weeks (one per week).
During the first website visit, the participants fill in a short PA questionnaire and based on the answers, they receive personal feedback about their behavior (pre-intentional processes). Knowledge is also provided by giving users the chance to fill in an optional quiz about PA and its beneficial effects. Post-intentional processes are targeted during this first visit by asking the participants to make an action plan. Participants are asked what they want to do (e.g. being more active by cycling during leisure time), when (e.g. every Sunday morning), where (e.g. in the streets nearby) and for how long (e.g. 60 minutes). After answering these questions, the participants can identify difficult situations and possible barriers (i.e. coping planning) while pursuing their goals. Dependent on which barriers they select, specific solutions are given and the participants could choose which ones they consider appropriate and want to apply. After this first website visit, the users can indicate how they want to self-monitor their behaviour (e.g. using an agenda).
One week after finishing the first website visit, the participants receive an email to revisit the website. During this second visit, they receive feedback about their behavioural change process and their goals (e.g. did the participant reach his/her goal or not?). Afterwards the participants have the possibility to adapt their action plan (e.g. setting new, more realistic goals). They can reconsider coping plans, based on barriers they experienced while pursuing their goals. Furthermore, participants can optionally read activity tips. Website visits 3, 4 and 5 are respectively activated one week after the previous visit. Again, the participants are reminded by email. These three last visits are identical to the second visit (review of the action and coping plan).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: MyPlan 2.0.The intervention group has access to the MyPlan 2.0. eHealth intervention. MyPlan is a eHealth intervention designed to increase physical activity. The intervention is based on the self-regulation theory and focuses on pre- and post-intentional processes to increase physical activity. |
| control group | No intervention | –The control group receives no intervention |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- retired
- able to walk 100 meters without assistance
- speak and understand Dutch
- have an email address
Key exclusion criteria (4 listed)
- severe physical health problems
- not retired
- not able to speak and understand Dutch
- not having an email address
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 |
|---|---|---|
| MyPlan 2.0.eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans. | Behavioural | Intervention group |
Primary outcome
change in accelerometer-based physical activity
Time frame: change between baseline and post (5 weeks after baseline)
participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity.
change in accelerometer-based physical activity
Time frame: change between baseline and follow-up (3 months after baseline)
participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity.
change in self-reported physical activity
Time frame: change between baseline and post (5 weeks after baseline)
the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
change in self-reported physical activity
Time frame: change between baseline and follow-up (3 months after baseline)
the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week.
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 16 May 2019.
- Derived from this study: PubMed 31593541Van Dyck D, Herman K, Poppe L, Crombez G, De Bourdeaudhuij I, Gheysen F. Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 7;21(10):e13219. doi: 10.2196/13219.
- Individual participant dataSharing planned: Yes. only researchers of our own research group will have access to the full data of the participants, only for research purposes. Only anonymized data will be shared with other researchers of our own research group. other researchers can obtain research information upon request
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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.
Greet Cardon, PhD principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing MyPlan 2.0. in people with Physical Activity and Older Adults, run by University Ghent.
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 4 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
change in accelerometer-based physical activity (time frame: change between baseline and post (5 weeks after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783611, which also lists 1 linked publication.
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 16 May 2019.