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Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274271
Recruitment Status : Unknown
Verified September 2017 by Vakgroepsport, University Ghent.
Recruitment status was:  Not yet recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vakgroepsport, University Ghent

Brief Summary:
The aim of this study is to investigate the effectiveness of intervention 'MyPlan 2.0' and the efficacy of the different behaviour change techniques that are included. Eight groups will be created that will receive a different version of the intervention, varying in three behaviour change techniques (action planning, coping planning, self-monitoring).

Condition or disease Intervention/treatment Phase
Disease, Chronic Behavioral: Action planning Behavioral: Coping planning Behavioral: Self-monitoring Behavioral: Feedback and tips Not Applicable

Detailed Description:
The effectiveness of the self-regulation-based e- and m-health intervention 'MyPlan 2.0' on changing physical activity and sedentary behaviour in the adult population will be investigated. Furthermore, the role of three different behaviour change techniques (action planning, coping planning, self-monitoring) will be examined via a 2x2x2 design, in which 8 groups are created that all receive a different version of the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2x2 design with 3 behaviour change techiques provided or not provided
Masking: Single (Participant)
Masking Description: The different participants will receive different website links to the intervention website, according to their group. The link will not provide information about their group.
Primary Purpose: Prevention
Official Title: A Parallel-group Randomized Trial to Compare the Efficacy of Different Behaviour Change Techniques in the e- and M-health Intervention 'MyPlan 2.0'
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: AP+CP+M

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with all three behaviour change techniques of interest: action planning (AP), coping planning (CP) and self-monitoring (M).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Action planning
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).

Behavioral: Coping planning
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.

Behavioral: Self-monitoring
Self-monitoring is the behaviour change technique used to make users keep track of their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: AP+CP

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and coping planning (CP).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Action planning
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).

Behavioral: Coping planning
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: AP+M

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: action planning (AP) and self-monitoring (M).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Action planning
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).

Behavioral: Self-monitoring
Self-monitoring is the behaviour change technique used to make users keep track of their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: CP+M

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with two of the behaviour change techniques of interest: coping planning (CP) and self-monitoring (M).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Coping planning
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.

Behavioral: Self-monitoring
Self-monitoring is the behaviour change technique used to make users keep track of their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: M

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: self-monitoring (M).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Self-monitoring
Self-monitoring is the behaviour change technique used to make users keep track of their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: CP

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: coping planning (CP).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Coping planning
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Experimental: AP

Participants will receive the e- and mHealth intervention 'MyPlan 2.0' with only one of the behaviour change techniques of interest: action planning (AP).

They will also receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.

Behavioral: Action planning
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).

Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.

Active Comparator: Control
Participants will receive the e- and mHealth intervention 'MyPlan 2.0' without the three behaviour change techniques of interest (action planning, coping planning, self-monitoring). They will receive general tips and tricks and other behaviour change techniques included in the intervention: tailored feedback and eliciting social support.
Behavioral: Feedback and tips
In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.




Primary Outcome Measures :
  1. Change in objective physical activity (PA) [ Time Frame: Baseline, 5 weeks, 3 months, 1 year ]
    Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers

  2. Change in objective sedentary behaviour [ Time Frame: Baseline, 5 weeks, 3 months, 1 year ]
    Change in amount of total sitting time, measured via accelerometers

  3. Change in self-reported physical activity (PA) [ Time Frame: Baseline, 5 weeks, 3 months, 1 year ]
    Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)

  4. Change in self-reported sedentary behaviour [ Time Frame: Baseline, 5 weeks, 3 months, 1 year ]
    Change in amount of total sitting time, measured via the last 7-days sedentary behaviour self-report questionnaire (SIT-Q-7d)


Secondary Outcome Measures :
  1. Change in self-efficacy [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)

  2. Change in motivation [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)

  3. Change in outcome expectancies [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)

  4. Change in risk perception [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Risk perception about the behaviour, measured via 3 validated items (questionnaire)

  5. Change in intention [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Amount of intention to change behaviour, measured via 3 validated items (questionnaire)

  6. Change in action planning [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)

  7. Change in coping planning [ Time Frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year ]
    Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 18 years old or older

Exclusion Criteria:

  • Not Dutch-speaking
  • Does not own a smartphone
  • Does not have access to the internet
  • Is not able to be physically active/non-sedentary

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274271


Contacts
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Contact: Celien Van der Mispel +32 9 264 63 63 celien.vandermispel@ugent.be
Contact: Louise Poppe +32 9 264 63 63 louise.poppe@ugent.be

Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Ilse De Bourdeaudhuij, Professor University Ghent
Principal Investigator: Geert Crombez, Professor University Ghent
Principal Investigator: Maïté Verloigne, PostDoc University Ghent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vakgroepsport, Professor, University Ghent
ClinicalTrials.gov Identifier: NCT03274271    
Other Study ID Numbers: MyPlan2.0
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vakgroepsport, University Ghent:
physical activity
sedentary behaviour
eHealth
mHealth
self-regulation
behaviour change techniques
action planning
coping planning
self-monitoring
prevention
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes