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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03291171
Enrollment
56
Registered
2017-09-25
Start date
2017-10-15
Completion date
2019-03-01
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

physical activity, sedentary behaviour, type 2 diabetes, eHealth, mHealth, self-regulation, behaviour change techniques

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.

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.

Interventions

BEHAVIORALMyPlan 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.

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* not Dutch Speaking

Design outcomes

Primary

MeasureTime frameDescription
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 behaviourPretest, 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 behaviourPretest, 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

MeasureTime frameDescription
change in action planningPretest, 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 self-efficacyPretest, 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 coping planningPretest, 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)
Change in outcome expectanciesPretest, 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 perceptionPretest, 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 intentionPretest, 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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026