- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04003324
Reducing Older Adults' Sedentary Behavior by Self-monitoring
Users' Experiences and Preliminary Efficacy of a Self-monitoring Tool to Reduce Sedentary Behavior in Older Adults: a Mixed-methods Study
Study Overview
Status
Conditions
Detailed Description
A mixed-method study will be conducted to assess participants' perceptions and preliminary efficacy of a self-monitoring based intervention aimed at the reduction of sedentary behavior in older adults (> 60 years).
A convenience sample of 40 older adults will be recruited using Facebook advertisements, as well as from an existing database of older adults willing to participate in research studies.
Older adults who agree to participate will be contacted by phone to make an appointment for a visit. During this first visit, participants will receive an informed consent. After signing the informed consent, a structured interview will be conducted to assess the participants' socio-demographic characteristics, domain-specific sedentary behavior and health status. A semi-structured interview will be conducted to examine participants' perceptions towards (reducing) sedentary behavior. Moreover, an inclinometer will be attached to the participants' thigh. Participants will be instructed to wear the inclinometer for one week. After one week, a researcher will visit the participants once again to collect the inclinometers. During this second visit, participants will receive a self-monitoring tool (i.e. the Activator) aimed at the reduction of sedentary behavior. Participants will be able to use the self-monitoring tool for four weeks. Apart from that, participants will receive a booklet with general sedentary behavior information and an explanation on how to use the self-monitoring tool. By the end of the intervention, the self-monitoring tools will be collected, and participants will be instructed to answer another structured interview and to wear the inclinometer for another week. At the end of this week, inclinometers will collected, and a semi-structured interview will be conducted with the older adults of the intervention group to gain insight into their experiences with self-monitoring as a behavior change technique to reduce sedentary behavior, as well as with the Activator.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be at least 60 years old
- be Dutch-speaking
- be able to walk 100 meters without severe difficulties
- have a smartphone
Exclusion Criteria:
- having functional limitations to stand up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Self-monitoring tool (Activator) and general information
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Participants will receive a self-monitoring tool (i.e. the Activator) aimed at the reduction of sedentary behavior.
Participants will be able to use the self-monitoring tool for four weeks.
Apart from that, participants will receive general sedentary behavior information and an explanation on how to use the self-monitoring tool.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sedentary behavior
Time Frame: Pretest - posttest (4 weeks)
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Total sedentary behavior was objectively estimated by means of the ActivPAL inclinometer (PAL Technologies, Glasgow, UK).
The inclinometer was attached on the midline of the right anterior thigh.
Participants were instructed to wear the inclinometer for seven consecutive days (24h/day) both at baseline, and at post measurement.
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Pretest - posttest (4 weeks)
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Perceptions of (reducing) sedentary behavior
Time Frame: Posttest (4 weeks)
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Perceptions of older adults' towards reducing sedentary behavior by means of a self-monitoring tool will be assessed using a semi-structured interview.
The interview guide has been developed by the principal investigator and includes open questions regarding older adults' perceptions towards 1) sedentary behavior, 2) using self-monitoring to reduce sedentary behavior and 3) the Activator (i.e. the self-monitoring tool used in our study).
Examples of questions are: What are your perceptions regarding the Activator?
Did you enjoy receiving feedback on your sitting time every day?
Etc.
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Posttest (4 weeks)
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Domain-specific sedentary behavior
Time Frame: Pretest - posttest (4 weeks)
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Domain-specific sedentary behaviors were assessed using a questionnaire developed by Busschaert et al.
Concretely, week and weekend day sedentary behaviors were asked using the following question: 'During the last 7 days, how much time did you usually spend sitting while (1) reading, (2) caring, (3) practicing hobbies, (4) socializing, (5) listening to/playing music, (6) consuming meals, (7) watching television, (8) using a computer, (9) moving from one place to another, (10) doing household activities (11) making phone calls.
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Pretest - posttest (4 weeks)
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Greet Cardon, Prof., University Ghent
Publications and helpful links
General Publications
- Compernolle S, Van Dyck D, Cardon G, Brondeel R. Exploring Breaks in Sedentary Behavior of Older Adults Immediately After Receiving Personalized Haptic Feedback: Intervention Study. JMIR Mhealth Uhealth. 2021 May 10;9(5):e26387. doi: 10.2196/26387.
- Compernolle S, Cardon G, van der Ploeg HP, Van Nassau F, De Bourdeaudhuij I, Jelsma JJ, Brondeel R, Van Dyck D. Engagement, Acceptability, Usability, and Preliminary Efficacy of a Self-Monitoring Mobile Health Intervention to Reduce Sedentary Behavior in Belgian Older Adults: Mixed Methods Study. JMIR Mhealth Uhealth. 2020 Oct 29;8(10):e18653. doi: 10.2196/18653.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Op is Top - Pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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