Clinical trial NCT03274271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Disease, Chronic
Keywords: physical activity
sedentary behaviour
eHealth
mHealth
self-regulation
behaviour change techniques
action planning
coping planning
self-monitoring
prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2 design with 3 behaviour change techiques provided or not provided
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in objective physical activity (PA)
timeFrame: Baseline, 5 weeks, 3 months, 1 year
measure: Change in objective sedentary behaviour
timeFrame: Baseline, 5 weeks, 3 months, 1 year
measure: Change in self-reported physical activity (PA)
timeFrame: Baseline, 5 weeks, 3 months, 1 year
measure: Change in self-reported sedentary behaviour
timeFrame: Baseline, 5 weeks, 3 months, 1 year
Secondary outcomes:
measure: Change in self-efficacy
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in motivation
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in outcome expectancies
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in risk perception
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in intention
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in action planning
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
measure: Change in coping planning
timeFrame: Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Ilse De Bourdeaudhuij, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Geert Crombez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Maïté Verloigne, PostDoc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.