An interventional study of MyPlan 2.0 in Chronic Disease, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.
The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'. 'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.
Behavioral: MyPlan 2.0
Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.
MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.
Change in objective total, light and moderate-to-vigorous physical activity (PA)
Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers
Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
Change in objective sedentary behaviour
Change in amount of total sitting time, measured via accelerometers
Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
Change in self-reported total, light and moderate-to-vigorous physical activity (PA)
Change in amount of total, light and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)
Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
Change in self-reported sedentary behaviour
Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire
Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)
Change in self-efficacy
Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Change in outcome expectancies
Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Change in risk perception
Risk perception about the behaviour, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Change in intention
Amount of intention to change the behaviour, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
change in action planning
Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
change in coping planning
Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)
Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Plan to share: No
Ran from Oct 2017 to primary completion in Mar 2019, 16 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 16 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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