Physical ActivityNCT02211040
eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults Who Visit General Practice
A study testing My Plan in people with Physical Activity and Fruit and Vegetable Intake, run by University Ghent at 1 site in Belgium.
Trial summary
The investigators have developed an eHealth intervention based on self-regulation for the promotion of self-regulation of physical activity and fruit and vegetable intake among adults who visit general practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Fruit and Vegetable Intake, Self-regulation
- What is being tested?
- My Plan
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Jul 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Having access to internet
Who cannot join
- No access to internet
- Younger than 18 years
- Not understanding the Dutch Language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Evaluation of an eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults in General Practice
The investigators have developed an eHealth intervention based on self-regulation for the promotion of self-regulation of physical activity and fruit and vegetable intake among adults who visit general practice. Effectiveness of the intervention will be evaluated in a three-arm clustered quasi-experimental design in general practice.
Read the detailed description
To increase effect sizes and reach of computer tailored interventions, the theory of self-regulation was used, motivational and volitional determinants were targeted and the intervention was not served as a stand-alone intervention but was delivered in general practice. The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice. Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice. In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness. Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods. In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans. To ensure the feasibility of implementing the intervention in general practice, general practitioners were involved from the beginning of the development.
A three-arm clustered quasi-experimental design will be used to evaluate the effectiveness of the intervention. Therefore, general practitioners will be recruited and patients will be randomly assigned at general practice level. Within each practice, patients can be allocated in three groups. Group one is an intervention group in which general practitioners select and motivate adults to use the intervention. In group two, the selection and motivation of adults will be conducted by a researcher in the waiting room and finally, group three will be a control group in which adults are also selected by a researcher. The distinction between the two intervention groups is made to evaluate if general practitioners influence when recruiting participants leads to beneficial effects compared to when investigators recruit participants. Furthermore, it will also be investigated if the implementation of the intervention by general practitioners is feasible.
In the intervention groups, adults are asked to complete session one (S1) and measurements questions on a tablet in general practice or are referred with a flyer to do this at their computer at home. Adults, who do not use the tablet, have to fill in a short questionnaire and leave their email address to send them a reminder email to complete session one at home. In session one, adults choose themselves for which behaviour(s) they want to complete the intervention. One week (S2) and one month (S3) after session one is completed, adults will receive an email to respectively start session two and three for the chosen behaviour(s). In the control group, adults have to fill in a questionnaire at base line in general practice or at home (C1) and one month post intervention (C2).
- Being tested
- My Plan
- Keywords
- Intervention Mapping Protocol, physical activity, fruit intake, vegetable intake, computer tailoring, eHealth, self-regulation, goal setting, problem solving, general practice
- Medical subject headings
- Motor Activity, Self-Control, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My PlanBehavioural
The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice.
Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice.
In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness.
Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods.
In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans.
| Study group | Role | What they receive |
|---|---|---|
| No general practitioner involvement | Experimental | The selection and motivation of adults will be conducted by a researcher in the waiting room. There is no extra motivation of the general practitioner. Receives: Behavioral: My Plan |
| General practitioner involvement | Experimental | An intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables. Receives: Behavioral: My Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline in physical activity level at 1 and 6 months"
Amount of physical activity per day and per week
Measured: After 1 and 6 months
"Change from Baseline in fruit and vegetable intake at 1 and 6 months"
Measured: After 1 and 6 months
Secondary outcomes (1)
"Change from Baseline in scores on self-regulation skills at 1 and 6 months"
Measured: After 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Welfare, Public Health and Family, Flemish government, Belgium
- Responsible party
- Principal investigator, Vakgroepsport, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211040
- Sponsor's protocol ID
- BE670201421382
- Status last verified
- May 2017
- First submitted
- 18 Jul 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Dyck D, Plaete J, Cardon G, Crombez G, De Bourdeaudhuij I. Effectiveness of the self-regulation eHealth intervention 'MyPlan1.0.' on physical activity levels of recently retired Belgian adults: a randomized controlled trial. Health Educ Res. 2016 Oct;31(5):653-64. doi: 10.1093/her/cyw036. Epub 2016 Jul 15.
PubMed 27422898Plaete J, Crombez G, Van der Mispel C, Verloigne M, Van Stappen V, De Bourdeaudhuij I. Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial. J Med Internet Res. 2016 Feb 29;18(2):e47. doi: 10.2196/jmir.5252.
PubMed 26929095
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of an eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults in General Practice
- ClinicalTrials.gov ID
- NCT02211040
- Acronym / sponsor ID
- BE670201421382
- Keywords
- Intervention Mapping Protocol, physical activity, fruit intake, vegetable intake, computer tailoring, eHealth, self-regulation, goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Welfare, Public Health and Family, Flemish government, Belgium
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- 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 investigators have developed an eHealth intervention based on self-regulation for the promotion of self-regulation of physical activity and fruit and vegetable intake among adults who visit general practice. Effectiveness of the intervention will be evaluated in a three-arm clustered quasi-experimental design in general practice.
Detailed description
To increase effect sizes and reach of computer tailored interventions, the theory of self-regulation was used, motivational and volitional determinants were targeted and the intervention was not served as a stand-alone intervention but was delivered in general practice. The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice. Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice. In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness. Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods. In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans. To ensure the feasibility of implementing the intervention in general practice, general practitioners were involved from the beginning of the development.
A three-arm clustered quasi-experimental design will be used to evaluate the effectiveness of the intervention. Therefore, general practitioners will be recruited and patients will be randomly assigned at general practice level. Within each practice, patients can be allocated in three groups. Group one is an intervention group in which general practitioners select and motivate adults to use the intervention. In group two, the selection and motivation of adults will be conducted by a researcher in the waiting room and finally, group three will be a control group in which adults are also selected by a researcher. The distinction between the two intervention groups is made to evaluate if general practitioners influence when recruiting participants leads to beneficial effects compared to when investigators recruit participants. Furthermore, it will also be investigated if the implementation of the intervention by general practitioners is feasible.
In the intervention groups, adults are asked to complete session one (S1) and measurements questions on a tablet in general practice or are referred with a flyer to do this at their computer at home. Adults, who do not use the tablet, have to fill in a short questionnaire and leave their email address to send them a reminder email to complete session one at home. In session one, adults choose themselves for which behaviour(s) they want to complete the intervention. One week (S2) and one month (S3) after session one is completed, adults will receive an email to respectively start session two and three for the chosen behaviour(s). In the control group, adults have to fill in a questionnaire at base line in general practice or at home (C1) and one month post intervention (C2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No general practitioner involvement | Experimental | Behavioral: My PlanThe selection and motivation of adults will be conducted by a researcher in the waiting room. There is no extra motivation of the general practitioner. |
| General practitioner involvement | Experimental | Behavioral: My PlanAn intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years
- Having access to internet
Key exclusion criteria (3 listed)
- No access to internet
- Younger than 18 years
- Not understanding the Dutch Language
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 |
|---|---|---|
| My PlanThe intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice. Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice. In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness. Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods. In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans. | Behavioural | General practitioner involvement, No general practitioner involvement |
Primary outcome
"Change from Baseline in physical activity level at 1 and 6 months"
Time frame: After 1 and 6 months
Amount of physical activity per day and per week
"Change from Baseline in fruit and vegetable intake at 1 and 6 months"
Time frame: After 1 and 6 months
1 secondary outcome
"Change from Baseline in scores on self-regulation skills at 1 and 6 months"
Time frame: After 1 and 6 months
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 5 May 2017.
- Derived from this study: PubMed 27422898Van Dyck D, Plaete J, Cardon G, Crombez G, De Bourdeaudhuij I. Effectiveness of the self-regulation eHealth intervention 'MyPlan1.0.' on physical activity levels of recently retired Belgian adults: a randomized controlled trial. Health Educ Res. 2016 Oct;31(5):653-64. doi: 10.1093/her/cyw036. Epub 2016 Jul 15.
- Derived from this study: PubMed 26929095Plaete J, Crombez G, Van der Mispel C, Verloigne M, Van Stappen V, De Bourdeaudhuij I. Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial. J Med Internet Res. 2016 Feb 29;18(2):e47. doi: 10.2196/jmir.5252.
- FundingLink provided by the sponsor.
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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 My Plan in people with Physical Activity and Fruit and Vegetable Intake, 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 2 inclusion and 3 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 5 May 2017. 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?
"Change from Baseline in physical activity level at 1 and 6 months" (time frame: After 1 and 6 months). The study lists 2 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 NCT02211040, which also lists 2 linked publications.
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 5 May 2017.