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Completed

NCT Number: NCT03291171

Identifying the Effect and Working Mechanisms of MyPlan 2.0 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.

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Key information

Conditions

Chronic Disease Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Movement and Sports Sciences

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not Dutch Speaking

Treatment and study plan

MyPlan 2.0

Behavioral

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.

Primary outcomes

  1. Change in objective total, light and moderate-to-vigorous physical activity (PA)

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers

  2. Change in objective sedentary behaviour

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    Change in amount of total sitting time, measured via accelerometers

  3. Change in self-reported total, light and moderate-to-vigorous physical activity (PA)

    Time frame: 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)

  4. Change in self-reported sedentary behaviour

    Time frame: 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 outcomes

  1. Change in self-efficacy

    Time frame: 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)

  2. Change in outcome expectancies

    Time frame: 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)

  3. Change in risk perception

    Time frame: 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)

  4. Change in intention

    Time frame: 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)

  5. change in action planning

    Time frame: 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)

  6. change in coping planning

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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