Clinical trial NCT03799146: Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: physical activity
sedentary behaviour
eHealth
mHealth
self-regulation
behaviour change techniques
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups: intervention group and waiting-list control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Have access to internet
* Being computer literate

Exclusion Criteria:

* non Dutch speaking

Primary outcomes:
measure: Change in objective total, light and moderate-to-vigorous physical activity (PA)
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: Change in objective sedentary behaviour
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: 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.
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
measure: Change in self-reported sedentary behaviour
timeFrame: Pretest, posttest (6 weeks) and follow-up (6 months)
Secondary outcomes:
measure: Change in self-efficacy
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
measure: Change in outcome expectancies
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
measure: Change in risk perception
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
measure: Change in intention
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
measure: Change in action planning
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
measure: Change in coping planning
timeFrame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Movement and Sports Sciences
Study officials:
affiliation: University Ghent
name: Ilse De Bourdeaudhuij
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Geert Crombez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.