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Chronic DiseaseNCT03291171

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

A study testing MyPlan 2.0 in people with Chronic Disease, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Disease
What is being tested?
MyPlan 2.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBelgium
Study dates
15 Oct 2017to 1 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • not Dutch Speaking

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Department of Movement and Sports Sciences

    Ghent, 9000

Other trials in Belgium

About this study

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.

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.

Read the 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.

Conditions
Chronic Disease
Being tested
MyPlan 2.0
Keywords
physical activity, sedentary behaviour, type 2 diabetes, eHealth, mHealth, self-regulation, behaviour change techniques
Medical subject headings
Chronic Disease, Motor Activity, Diabetes Mellitus, Type 2, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyPlan 2.0Behavioural

    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.

Study groups in NCT03291171
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants will receive the e- and mHealth intervention 'MyPlan 2.0'.
Receives: Behavioral: MyPlan 2.0
Waiting-list control groupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Change in objective sedentary behaviour

    Change in amount of total sitting time, measured via accelerometers

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

  3. 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)

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

  4. Change in self-reported sedentary behaviour

    Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire

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

Secondary outcomes (6)

  1. Change in self-efficacy

    Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  2. Change in outcome expectancies

    Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  3. Change in risk perception

    Risk perception about the behaviour, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  4. Change in intention

    Amount of intention to change the behaviour, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  5. change in action planning

    Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  6. change in coping planning

    Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)

    Measured: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start15 Oct 2017
  3. Primary completion1 Mar 2019
  4. Study completion1 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial with two groups: intervention group and waiting-list control group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291171
Sponsor's protocol ID
MyPlan2.0_diabetes
Status last verified
Dec 2021
First submitted
11 Sep 2017
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.

    PubMed 31376274

Questions about this trial

What is this clinical trial studying?

A study testing MyPlan 2.0 in people with Chronic Disease, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in objective total, light and moderate-to-vigorous physical activity (PA) (time frame: Pretest, posttest (6 weeks) and follow-up (6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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