- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211040
eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults Who Visit General Practice
Effect Evaluation of an eHealth Intervention to Promote Self-regulation of Physical Activity and Fruit and Vegetable Intake Among Adults in General Practice
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
East Flanders
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Ghent, East Flanders, Belgium, 9000
- Jolien Plaete
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older than 18 years
- Having access to internet
Exclusion Criteria:
- No access to internet
- Younger than 18 years
- Not understanding the Dutch Language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: No general practitioner involvement
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.
|
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. |
Experimental: General practitioner involvement
An intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"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
|
After 1 and 6 months
|
"Change from Baseline in fruit and vegetable intake at 1 and 6 months"
Time Frame: After 1 and 6 months
|
After 1 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
"Change from Baseline in scores on self-regulation skills at 1 and 6 months"
Time Frame: After 1 and 6 months
|
After 1 and 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Plaete 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BE670201421382
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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