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CompletedNCT03274271Updated Dec 6, 2021

Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

An interventional study of Action planning and Coping planning in Disease, Chronic, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by University Ghent · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Disease, Chronic

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Keywords

  • physical activity
  • sedentary behaviour
  • eHealth
  • mHealth
  • self-regulation
  • behaviour change techniques
  • action planning
  • coping planning
  • self-monitoring
  • prevention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years old or older

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
500 participants (actual)

Study arms

  • 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 · Behavioral: Coping planning · Behavioral: Self-monitoring · Behavioral: Feedback and tips

  • 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 · Behavioral: Coping planning · Behavioral: Feedback and tips

  • 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 · Behavioral: Self-monitoring · Behavioral: Feedback and tips

  • 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 · Behavioral: Self-monitoring · Behavioral: Feedback and tips

  • 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 · Behavioral: Feedback and tips

  • 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 · Behavioral: Feedback and tips

  • 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 · Behavioral: Feedback and tips

  • 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

Interventions

  • BehavioralAction planning

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

  • BehavioralCoping 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.

  • BehavioralSelf-monitoring

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

  • BehavioralFeedback 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'.

05

What researchers measure

Primary outcomes

  1. Change in objective physical activity (PA)

    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

  2. Change in objective sedentary behaviour

    Change in amount of total sitting time, measured via accelerometers

    Time frame: Baseline, 5 weeks, 3 months, 1 year

  3. 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)

    Time frame: Baseline, 5 weeks, 3 months, 1 year

  4. 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)

    Time frame: Baseline, 5 weeks, 3 months, 1 year

Secondary outcomes

  1. Change in self-efficacy

    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

  2. Change in motivation

    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

  3. Change in outcome expectancies

    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

  4. Change in risk perception

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

    Time frame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  5. Change in intention

    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

  6. Change in action planning

    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

  7. Change in coping planning

    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

06

Study locations

1 site
  • University Ghent
    Ghent, East-Flanders 9000, Belgium
07

References and documents

Publications

  • 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. PubMed 35099400 ↗
  • 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. PubMed 33028335 ↗
  • 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. PubMed 31182147 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03274271
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Sep 1, 2017
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Dec 6, 2021

Study contacts

Ilse De Bourdeaudhuij, Professor
principal investigator · University Ghent
Geert Crombez, Professor
principal investigator · University Ghent
Maïté Verloigne, PostDoc
principal investigator · University Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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