NCT03799146

Brief Summary

The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

January 7, 2019

Last Update Submit

December 3, 2021

Conditions

Keywords

physical activitysedentary behavioureHealthmHealthself-regulationbehaviour change techniques

Outcome Measures

Primary Outcomes (4)

  • Change in objective total, light and moderate-to-vigorous physical activity (PA)

    Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers

    Pretest, posttest (6 weeks) and follow-up (6 months)

  • Change in objective sedentary behaviour

    Change in amount of total sitting time, measured via accelerometers

    Pretest, posttest (6 weeks) and follow-up (6 months)

  • Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA.

    Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data.

    Pretest, posttest (6 weeks) and follow-up (6 months)

  • Change in self-reported sedentary behaviour

    Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours.

    Pretest, posttest (6 weeks) and follow-up (6 months)

Secondary Outcomes (6)

  • Change in self-efficacy

    Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

  • Change in outcome expectancies

    Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

  • Change in risk perception

    Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

  • Change in intention

    Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

  • Change in action planning

    Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.

Behavioral: MyPlan 2.0

Waiting List control group

EXPERIMENTAL

Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.

Other: Waiting List

Interventions

MyPlan 2.0BEHAVIORAL

MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.

Intervention group

Waiting List control group

Waiting List control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have access to internet
  • Being computer literate

You may not qualify if:

  • non Dutch speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Movement and Sports Sciences

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.

MeSH Terms

Conditions

OverweightMotor ActivitySelf-Control

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Ilse De Bourdeaudhuij

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Geert Crombez

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with two groups: intervention group and waiting-list control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 10, 2019

Study Start

January 15, 2018

Primary Completion

August 15, 2018

Study Completion

April 15, 2019

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations