Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults

A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Behavioral: MyPlan 2.0; Other: Waiting List

Detailed Description

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. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'.

'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Department of Movement and Sports Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have access to internet
• Being computer literate

Exclusion Criteria:

• non Dutch speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.	Behavioral: MyPlan 2.0; 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.
Experimental: Waiting List control group; 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; Waiting List control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy	Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.	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	Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score.	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	Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
Change in intention	Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.	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	Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
Change in coping planning	Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.	Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Ilse De Bourdeaudhuij, University Ghent; Principal Investigator: Geert Crombez, University Ghent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 10, 2019

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; mHealth; sedentary behaviour; eHealth; self-regulation; behaviour change techniques
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: MyPlan2.0_older_adults_50

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