Disease, ChronicNCT03274271
Efficacy of Different Behaviour Change Techniques in MyPlan 2.0
A study testing Action planning, Coping planning and Self-monitoring in people with Disease, Chronic, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease, Chronic
- What is being tested?
- Action planning, Coping planning and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 1 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
Who cannot join
- Not Dutch-speaking
- Does not own a smartphone
- Does not have access to the internet
- Is not able to be physically active/non-sedentary
Trial locations and contacts
1 site in 1 country.
About this study
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'
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).
Read the 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.
- Conditions
- Disease, Chronic
- Being tested
- Action planning, Coping planning, Self-monitoring, Feedback and tips
- Keywords
- physical activity, sedentary behaviour, eHealth, mHealth, self-regulation, behaviour change techniques, action planning, coping planning, self-monitoring, prevention
- Medical subject headings
- Chronic Disease, Motor Activity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action planningBehavioural
Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).
Coping planningBehavioural
Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.
Self-monitoringBehavioural
Self-monitoring is the behaviour change technique used to make users keep track of their goal.
Feedback and tipsBehavioural
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'.
| Study group | Role | What they receive |
|---|---|---|
| AP+CP+M | Experimental | 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. Receives: Behavioral: Action planning; Behavioral: Coping planning; Behavioral: Self-monitoring; Behavioral: Feedback and tips |
| AP+CP | Experimental | 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. Receives: Behavioral: Action planning; Behavioral: Coping planning; Behavioral: Feedback and tips |
| AP+M | Experimental | 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. Receives: Behavioral: Action planning; Behavioral: Self-monitoring; Behavioral: Feedback and tips |
| CP+M | Experimental | 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. Receives: Behavioral: Coping planning; Behavioral: Self-monitoring; Behavioral: Feedback and tips |
| M | Experimental | 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. Receives: Behavioral: Self-monitoring; Behavioral: Feedback and tips |
| CP | Experimental | 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. Receives: Behavioral: Coping planning; Behavioral: Feedback and tips |
| AP | Experimental | 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. Receives: Behavioral: Action planning; Behavioral: Feedback and tips |
| Control | Active comparator | 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. Receives: Behavioral: Feedback and tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective physical activity (PA)
Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers
Measured: Baseline, 5 weeks, 3 months, 1 year
Change in objective sedentary behaviour
Change in amount of total sitting time, measured via accelerometers
Measured: Baseline, 5 weeks, 3 months, 1 year
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)
Measured: Baseline, 5 weeks, 3 months, 1 year
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)
Measured: Baseline, 5 weeks, 3 months, 1 year
Secondary outcomes (7)
Change in self-efficacy
Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in motivation
Change in amount of motivation to change behaviour, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in outcome expectancies
Outcome expectancies regarding the behaviour change, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in risk perception
Risk perception about the behaviour, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in intention
Amount of intention to change behaviour, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in action planning
Amount of action planning for behaviour change, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in coping planning
Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire)
Measured: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disease, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2 design with 3 behaviour change techiques provided or not provided
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilse De Bourdeaudhuij, Professor, Principal investigator, University GhentGeert Crombez, Professor, Principal investigator, University GhentMaïté Verloigne, PostDoc, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274271
- Sponsor's protocol ID
- MyPlan2.0
- Status last verified
- Dec 2021
- First submitted
- 20 Jun 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
Schroe H, Carlier S, Van Dyck D, De Backere F, Crombez G. Towards more personalized digital health interventions: a clustering method of action and coping plans to promote physical activity. BMC Public Health. 2022 Dec 12;22(1):2325. doi: 10.1186/s12889-022-14455-4.
PubMed 36510181Schroe 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.
PubMed 35099400Schroe 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.
PubMed 33028335Schroe 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.
PubMed 31182147
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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'
- ClinicalTrials.gov ID
- NCT03274271
- Acronym / sponsor ID
- MyPlan2.0
- Conditions
- Disease, Chronic
- Keywords
- physical activity, sedentary behaviour, eHealth, mHealth, self-regulation, behaviour change techniques, action planning, coping planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- 2x2x2 design with 3 behaviour change techiques provided or not provided
| Arm | Type | Receives |
|---|---|---|
| AP+CP+M | Experimental | Behavioral: Action planning, Behavioral: Coping planning, Behavioral: Self-monitoring, Behavioral: Feedback and tipsParticipants 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. |
| AP+CP | Experimental | Behavioral: Action planning, Behavioral: Coping planning, Behavioral: Feedback and tipsParticipants 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. |
| AP+M | Experimental | Behavioral: Action planning, Behavioral: Self-monitoring, Behavioral: Feedback and tipsParticipants 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. |
| CP+M | Experimental | Behavioral: Coping planning, Behavioral: Self-monitoring, Behavioral: Feedback and tipsParticipants 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. |
| M | Experimental | Behavioral: Self-monitoring, Behavioral: Feedback and tipsParticipants 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. |
| CP | Experimental | Behavioral: Coping planning, Behavioral: Feedback and tipsParticipants 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. |
| AP | Experimental | Behavioral: Action planning, Behavioral: Feedback and tipsParticipants 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. |
| Control | Active comparator | Behavioral: Feedback and tipsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old or older
Key exclusion criteria (4 listed)
- Not Dutch-speaking
- Does not own a smartphone
- Does not have access to the internet
- Is not able to be physically active/non-sedentary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action planningAction planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...). | Behavioural | AP, AP+CP, AP+CP+M, AP+M |
| Coping planningCoping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal. | Behavioural | AP+CP, AP+CP+M, CP, CP+M |
| Self-monitoringSelf-monitoring is the behaviour change technique used to make users keep track of their goal. | Behavioural | AP+CP+M, AP+M, CP+M, M |
| Feedback and tipsIn 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'. | Behavioural | AP, AP+CP, AP+CP+M, AP+M, CP, CP+M, Control, M |
Primary outcome
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
Change in objective sedentary behaviour
Time frame: Baseline, 5 weeks, 3 months, 1 year
Change in amount of total sitting time, measured via accelerometers
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)
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)
7 secondary outcomes
Change in self-efficacy
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in motivation
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in outcome expectancies
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in risk perception
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in intention
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in action planning
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Change in coping planning
Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 36510181Schroe H, Carlier S, Van Dyck D, De Backere F, Crombez G. Towards more personalized digital health interventions: a clustering method of action and coping plans to promote physical activity. BMC Public Health. 2022 Dec 12;22(1):2325. doi: 10.1186/s12889-022-14455-4.
- Derived from this study: PubMed 35099400Schroe 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.
- Derived from this study: PubMed 33028335Schroe 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.
- Derived from this study: PubMed 31182147Schroe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilse De Bourdeaudhuij, Professor principal investigator
University Ghent
Geert Crombez, Professor principal investigator
University Ghent
Maïté Verloigne, PostDoc principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action planning, Coping planning and Self-monitoring in people with Disease, Chronic, 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 1 inclusion and 4 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 physical activity (PA) (time frame: Baseline, 5 weeks, 3 months, 1 year). 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 NCT03274271, which also lists 4 linked publications.
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.