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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: MyPlan 2.0

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
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Department of Movement and Sports Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• not Dutch Speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pretest, posttest (6 weeks) and follow-up (6 months)
Change in objective sedentary behaviour	Change in amount of total sitting time, measured via accelerometers	Pretest, posttest (6 weeks) and follow-up (6 months)
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)	Pretest, posttest (6 weeks) and follow-up (6 months)
Change in self-reported sedentary behaviour	Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire	Pretest, posttest (6 weeks) and follow-up (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy	Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)	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	Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)	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	Risk perception about the behaviour, measured via 3 validated items (questionnaire)	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
Change in intention	Amount of intention to change the behaviour, measured via 3 validated items (questionnaire)	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
change in action planning	Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)	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	Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; type 2 diabetes; mHealth; sedentary behaviour; eHealth; self-regulation; behaviour change techniques
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Chronic Disease
• Other Study ID Numbers: MyPlan2.0_diabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No