Efficacy of Different Behaviour Change Techniques in MyPlan 2.0

Disease, Chronic Clinical Trial

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274271
• Other study ID #: MyPlan2.0
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, coping planning, self-monitoring).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Disease, Chronic

Intervention

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

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in objective sedentary behaviour	Change in amount of total sitting time, measured via accelerometers	Baseline, 5 weeks, 3 months, 1 year
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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