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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
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 11, 2017
Last Updated
December 3, 2021
Sponsor
University Ghent
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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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