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Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

Primary Purpose

Disease, Chronic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Action planning
Coping planning
Self-monitoring
Feedback and tips
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disease, Chronic focused on measuring physical activity, sedentary behaviour, eHealth, mHealth, self-regulation, behaviour change techniques, action planning, coping planning, self-monitoring, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

AP+CP+M

AP+CP

AP+M

CP+M

M

CP

AP

Control

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in objective physical activity (PA)
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers
Change in objective sedentary behaviour
Change in amount of total sitting time, measured via accelerometers
Change in self-reported physical activity (PA)
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)
Change in self-reported sedentary behaviour
Change in amount of total sitting time, measured via the last 7-days sedentary behaviour self-report questionnaire (SIT-Q-7d)

Secondary Outcome Measures

Change in self-efficacy
Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
Change in motivation
Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)
Change in outcome expectancies
Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
Change in risk perception
Risk perception about the behaviour, measured via 3 validated items (questionnaire)
Change in intention
Amount of intention to change behaviour, measured via 3 validated items (questionnaire)
Change in action planning
Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
Change in coping planning
Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)

Full Information

First Posted
June 20, 2017
Last Updated
December 3, 2021
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03274271
Brief Title
Efficacy of Different Behaviour Change Techniques in MyPlan 2.0
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'
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease, Chronic
Keywords
physical activity, sedentary behaviour, eHealth, mHealth, self-regulation, behaviour change techniques, action planning, coping planning, self-monitoring, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2x2 design with 3 behaviour change techiques provided or not provided
Masking
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.
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP+CP+M
Arm Type
Experimental
Arm Description
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.
Arm Title
AP+CP
Arm Type
Experimental
Arm Description
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.
Arm Title
AP+M
Arm Type
Experimental
Arm Description
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.
Arm Title
CP+M
Arm Type
Experimental
Arm Description
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.
Arm Title
M
Arm Type
Experimental
Arm Description
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.
Arm Title
CP
Arm Type
Experimental
Arm Description
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.
Arm Title
AP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Action planning
Intervention Description
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).
Intervention Type
Behavioral
Intervention Name(s)
Coping planning
Intervention Description
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring
Intervention Description
Self-monitoring is the behaviour change technique used to make users keep track of their goal.
Intervention Type
Behavioral
Intervention Name(s)
Feedback and tips
Intervention Description
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 Measure Information:
Title
Change in objective physical activity (PA)
Description
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers
Time Frame
Baseline, 5 weeks, 3 months, 1 year
Title
Change in objective sedentary behaviour
Description
Change in amount of total sitting time, measured via accelerometers
Time Frame
Baseline, 5 weeks, 3 months, 1 year
Title
Change in self-reported physical activity (PA)
Description
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)
Time Frame
Baseline, 5 weeks, 3 months, 1 year
Title
Change in self-reported sedentary behaviour
Description
Change in amount of total sitting time, measured via the last 7-days sedentary behaviour self-report questionnaire (SIT-Q-7d)
Time Frame
Baseline, 5 weeks, 3 months, 1 year
Secondary Outcome Measure Information:
Title
Change in self-efficacy
Description
Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in motivation
Description
Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in outcome expectancies
Description
Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in risk perception
Description
Risk perception about the behaviour, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in intention
Description
Amount of intention to change behaviour, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in action planning
Description
Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Title
Change in coping planning
Description
Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)
Time Frame
Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilse De Bourdeaudhuij, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geert Crombez, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maïté Verloigne, PostDoc
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35099400
Citation
Schroe H, Crombez G, De Bourdeaudhuij I, Van Dyck D. Investigating When, Which, and Why Users Stop Using a Digital Health Intervention to Promote an Active Lifestyle: Secondary Analysis With A Focus on Health Action Process Approach-Based Psychological Determinants. JMIR Mhealth Uhealth. 2022 Jan 31;10(1):e30583. doi: 10.2196/30583.
Results Reference
derived
PubMed Identifier
33028335
Citation
Schroe H, Van Dyck D, De Paepe A, Poppe L, Loh WW, Verloigne M, Loeys T, De Bourdeaudhuij I, Crombez G. Which behaviour change techniques are effective to promote physical activity and reduce sedentary behaviour in adults: a factorial randomized trial of an e- and m-health intervention. Int J Behav Nutr Phys Act. 2020 Oct 7;17(1):127. doi: 10.1186/s12966-020-01001-x.
Results Reference
derived
PubMed Identifier
31182147
Citation
Schroe H, Van der Mispel C, De Bourdeaudhuij I, Verloigne M, Poppe L, Crombez G. A factorial randomised controlled trial to identify efficacious self-regulation techniques in an e- and m-health intervention to target an active lifestyle: study protocol. Trials. 2019 Jun 10;20(1):340. doi: 10.1186/s13063-019-3456-7.
Results Reference
derived

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Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

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