Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MyPlan 2.0
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring physical activity, sedentary behaviour, type 2 diabetes, eHealth, mHealth, self-regulation, behaviour change techniques
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Type 2 diabetes
- Have access to internet
- Being computer literate
Exclusion Criteria:
- not Dutch Speaking
Sites / Locations
- Department of Movement and Sports Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Waiting-list control group
Arm Description
Participants will receive the e- and mHealth intervention '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.
Outcomes
Primary Outcome Measures
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
Change in objective sedentary behaviour
Change in amount of total sitting time, measured via accelerometers
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)
Change in self-reported sedentary behaviour
Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire
Secondary Outcome Measures
Change in self-efficacy
Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
Change in outcome expectancies
Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
Change in risk perception
Risk perception about the behaviour, measured via 3 validated items (questionnaire)
Change in intention
Amount of intention to change the behaviour, measured via 3 validated items (questionnaire)
change in action planning
Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
change in coping planning
Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03291171
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
physical activity, sedentary behaviour, type 2 diabetes, eHealth, mHealth, self-regulation, behaviour change techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two groups: intervention group and waiting-list control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.
Arm Title
Waiting-list control group
Arm Type
No Intervention
Arm Description
Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.
Intervention Type
Behavioral
Intervention Name(s)
MyPlan 2.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in objective total, light and moderate-to-vigorous physical activity (PA)
Description
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)
Title
Change in objective sedentary behaviour
Description
Change in amount of total sitting time, measured via accelerometers
Time Frame
Pretest, posttest (6 weeks) and follow-up (6 months)
Title
Change in self-reported total, light and moderate-to-vigorous physical activity (PA)
Description
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)
Title
Change in self-reported sedentary behaviour
Description
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)
Secondary Outcome Measure Information:
Title
Change in self-efficacy
Description
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)
Title
Change in outcome expectancies
Description
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)
Title
Change in risk perception
Description
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)
Title
Change in intention
Description
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)
Title
change in action planning
Description
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)
Title
change in coping planning
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Type 2 diabetes
Have access to internet
Being computer literate
Exclusion Criteria:
not Dutch Speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilse De Bourdeaudhuij, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geert Crombez, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maïté Verloigne, PostDoc
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Movement and Sports Sciences
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31376274
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.
Results Reference
derived
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Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes
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