Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

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).

Study Overview

• Status: Completed
• Conditions: Disease, Chronic
• Intervention / Treatment: Behavioral: Action planning; Behavioral: Coping planning; Behavioral: Self-monitoring; Behavioral: Feedback and tips

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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • University Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective physical activity (PA)	Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers	Baseline, 5 weeks, 3 months, 1 year
Change in objective sedentary behaviour	Change in amount of total sitting time, measured via accelerometers	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)	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)	Baseline, 5 weeks, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy	Change in amount of self-efficacy to change behaviour, measured via 3 validated items (questionnaire)	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)	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)	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)	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)	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)	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)	Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Ilse De Bourdeaudhuij, Professor, University Ghent; Principal Investigator: Geert Crombez, Professor, University Ghent; Principal Investigator: Maïté Verloigne, PostDoc, University Ghent

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; prevention; mHealth; sedentary behaviour; eHealth; self-regulation; behaviour change techniques; action planning; coping planning; self-monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: MyPlan2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No