ClinicalTrials.gov
ClinicalTrials.gov Menu

Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03291171
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Vakgroepsport, University Ghent

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: MyPlan 2.0 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with two groups: intervention group and waiting-list control group
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.
Behavioral: MyPlan 2.0
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.

No Intervention: Waiting-list control group
Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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 Outcome Measures :
  1. Change in self-efficacy [ 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 amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)

  2. Change in outcome expectancies [ Time Frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) ]
    Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)

  3. Change in risk perception [ Time Frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) ]
    Risk perception about the behaviour, measured via 3 validated items (questionnaire)

  4. Change in intention [ Time Frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) ]
    Amount of intention to change the behaviour, measured via 3 validated items (questionnaire)

  5. change in action planning [ Time Frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) ]
    Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)

  6. change in coping planning [ Time Frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) ]
    Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not Dutch Speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291171


Contacts
Contact: Louise Poppe +32 9 264 63 63 louise.poppe@ugent.be
Contact: Celien Van der Mispel +32 9 264 63 63 celien.vandermispel@ugent.be

Locations
Belgium
Department of Movement and Sports Sciences Recruiting
Ghent, Belgium, 9000
Contact: Louise Poppe       louise.poppe@ugent.be   
Contact: Maïté Verloigne       maite.verloigne@ugent.be   
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Ilse De Bourdeaudhuij, Professor University Ghent
Principal Investigator: Geert Crombez, Professor University Ghent
Principal Investigator: Maïté Verloigne, PostDoc University Ghent

Responsible Party: Vakgroepsport, Professor, University Ghent
ClinicalTrials.gov Identifier: NCT03291171     History of Changes
Other Study ID Numbers: MyPlan2.0_diabetes
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vakgroepsport, University Ghent:
physical activity
sedentary behaviour
type 2 diabetes
eHealth
mHealth
self-regulation
behaviour change techniques

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Chronic Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes