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

Chronic Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291171
• Other study ID #: MyPlan2.0_diabetes
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Type 2 diabetes

• Have access to internet

• Being computer literate

Exclusion Criteria:

• not Dutch Speaking

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Belgium	Department of Movement and Sports Sciences	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change in objective sedentary behaviour	Change in amount of total sitting time, measured via accelerometers	Pretest, posttest (6 weeks) and follow-up (6 months)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)