NCT03274271

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

June 20, 2017

Last Update Submit

December 3, 2021

Conditions

Keywords

physical activitysedentary behavioureHealthmHealthself-regulationbehaviour change techniquesaction planningcoping planningself-monitoringprevention

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Change in self-efficacy

    Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  • Change in motivation

    Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  • Change in outcome expectancies

    Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  • Change in risk perception

    Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  • Change in intention

    Baseline, 1 week, 3 weeks, 5 weeks, 3 months, 1 year

  • +2 more secondary outcomes

Study Arms (8)

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.

Behavioral: Action planningBehavioral: Coping planningBehavioral: Self-monitoringBehavioral: 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.

Behavioral: Action planningBehavioral: Coping planningBehavioral: 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.

Behavioral: Action planningBehavioral: Self-monitoringBehavioral: 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.

Behavioral: Coping planningBehavioral: Self-monitoringBehavioral: 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.

Behavioral: Self-monitoringBehavioral: 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.

Behavioral: Coping planningBehavioral: 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.

Behavioral: Action planningBehavioral: 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.

Behavioral: Feedback and tips

Interventions

Action planningBEHAVIORAL

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

APAP+CPAP+CP+MAP+M
Coping planningBEHAVIORAL

Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.

AP+CPAP+CP+MCPCP+M
Self-monitoringBEHAVIORAL

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

AP+CP+MAP+MCP+MM

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'.

APAP+CPAP+CP+MAP+MCPCP+MControlM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 18 years old or older

You may not qualify if:

  • Not Dutch-speaking
  • Does not own a smartphone
  • Does not have access to the internet
  • Is not able to be physically active/non-sedentary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (4)

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic DiseaseMotor ActivitySelf-Control

Interventions

Blood Glucose Self-MonitoringPortasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesPortasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Ilse De Bourdeaudhuij, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Geert Crombez, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Maïté Verloigne, PostDoc

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The different participants will receive different website links to the intervention website, according to their group. The link will not provide information about their group.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2x2x2 design with 3 behaviour change techiques provided or not provided
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

September 6, 2017

Study Start

September 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations