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

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT03291171

Collaborator

(none)

Enrollment

Location

Arms

16.5

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease	Behavioral: MyPlan 2.0	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial with two groups: intervention group and waiting-list control groupRandomized 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 :

Oct 15, 2017

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in objective total, light and moderate-to-vigorous physical activity (PA) [Pretest, posttest (6 weeks) and follow-up (6 months)]
Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers
Change in objective sedentary behaviour [Pretest, posttest (6 weeks) and follow-up (6 months)]
Change in amount of total sitting time, measured via accelerometers
Change in self-reported total, light and moderate-to-vigorous physical activity (PA) [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)
Change in self-reported sedentary behaviour [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

Change in self-efficacy [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)
Change in outcome expectancies [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)
Change in risk perception [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)
Change in intention [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)
change in action planning [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)
change in coping planning [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)