Clinical trial NCT03291171: Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes
Official title: A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Adults With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: physical activity
sedentary behaviour
type 2 diabetes
eHealth
mHealth
self-regulation
behaviour change techniques
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups: intervention group and waiting-list control group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Type 2 diabetes
* Have access to internet
* Being computer literate

Exclusion Criteria:

* not Dutch Speaking

Primary outcomes:
measure: Change in objective total, light and moderate-to-vigorous physical activity (PA)
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: Change in objective sedentary behaviour
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: Change in self-reported total, light and moderate-to-vigorous physical activity (PA)
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: Change in self-reported sedentary behaviour
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
Secondary outcomes:
measure: Change in self-efficacy
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: Change in outcome expectancies
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: Change in risk perception
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: Change in intention
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: change in action planning
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: change in coping planning
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Movement and Sports Sciences
Study officials:
affiliation: University Ghent
name: Ilse De Bourdeaudhuij, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Geert Crombez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Maïté Verloigne, PostDoc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.