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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: MyPlan 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Type 2 diabetes Have access to internet Being computer literate Exclusion Criteria: not Dutch Speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two groups: intervention group and waiting-list control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive the e- and mHealth intervention 'MyPlan 2.0'. | Behavioral: MyPlan 2.0<br>* 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.<br>|
| No Intervention: Waiting-list control group<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, type 2 diabetes, mHealth, self-regulation, behaviour change techniques, physical activity, sedentary behaviour