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Clinical Trials/NCT03291171
NCT03291171
Completed
N/A

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.

University Ghent1 site in 1 country56 target enrollmentOctober 15, 2017
ConditionsChronic Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
University Ghent
Enrollment
56
Locations
1
Primary Endpoint
Change in objective total, light and moderate-to-vigorous physical activity (PA)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2017
End Date
March 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • not Dutch Speaking

Outcomes

Primary Outcomes

Change in objective total, light and moderate-to-vigorous physical activity (PA)

Time Frame: Pretest, posttest (6 weeks) and follow-up (6 months)

Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers

Change in objective sedentary behaviour

Time Frame: Pretest, posttest (6 weeks) and follow-up (6 months)

Change in amount of total sitting time, measured via accelerometers

Change in self-reported total, light and moderate-to-vigorous physical activity (PA)

Time Frame: Pretest, posttest (6 weeks) and follow-up (6 months)

Change in amount of total, light and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)

Change in self-reported sedentary behaviour

Time Frame: Pretest, posttest (6 weeks) and follow-up (6 months)

Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire

Secondary Outcomes

  • change in action planning(Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months))
  • Change in self-efficacy(Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months))
  • Change in intention(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(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(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(Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months))

Study Sites (1)

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