Sedentary LifestyleNCT04003324
Reducing Older Adults' Sedentary Behavior by Self-monitoring
A study testing Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults in people with Sedentary Lifestyle, run by VakgroepBewegingsEnSportwetenschappen at 1 site in Belgium.
Trial summary
The first aim of this study is to gain insight into older adults' perceptions towards a self-monitoring tool aimed at the reduction of sedentary behavior. Secondly, this study aimed to investigate the preliminary efficacy of a self-monitoring tool aimed at the reduction of sedentary behavior. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Apr 2019to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 60 years old
- be Dutch-speaking
- be able to walk 100 meters without severe difficulties
- have a smartphone
Who cannot join
- having functional limitations to stand up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Users' Experiences and Preliminary Efficacy of a Self-monitoring Tool to Reduce Sedentary Behavior in Older Adults: a Mixed-methods Study
The first aim of this study is to gain insight into older adults' perceptions towards a self-monitoring tool aimed at the reduction of sedentary behavior. Secondly, this study aimed to investigate the preliminary efficacy of a self-monitoring tool aimed at the reduction of sedentary behavior.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Op is Top - using feedback from the Activator to reduce sedentary behavior in older adultsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Self-monitoring tool (Activator) and general information Receives: Behavioral: Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sedentary behavior
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.
Measured: Pretest - posttest (4 weeks)
Perceptions of (reducing) sedentary behavior
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.
Measured: Posttest (4 weeks)
Domain-specific sedentary behavior
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.
Measured: Pretest - posttest (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start19 Apr 2019
- Primary completion8 May 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VakgroepBewegingsEnSportwetenschappen
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor-investigator, VakgroepBewegingsEnSportwetenschappen, University Ghent
- Investigators
- Greet Cardon, Prof., Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003324
- Sponsor's protocol ID
- Op is Top - Pilot
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33970109Compernolle 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.
PubMed 33118951
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Users' Experiences and Preliminary Efficacy of a Self-monitoring Tool to Reduce Sedentary Behavior in Older Adults: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT04003324
- Acronym / sponsor ID
- Op is Top - Pilot
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VakgroepBewegingsEnSportwetenschappenUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first aim of this study is to gain insight into older adults' perceptions towards a self-monitoring tool aimed at the reduction of sedentary behavior. Secondly, this study aimed to investigate the preliminary efficacy of a self-monitoring tool aimed at the reduction of sedentary behavior.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Op is Top - using feedback from the Activator to reduce sedentary behavior in older adultsSelf-monitoring tool (Activator) and general information |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 60 years old
- be Dutch-speaking
- be able to walk 100 meters without severe difficulties
- have a smartphone
Key exclusion criteria (1 listed)
- having functional limitations to stand up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Op is Top - using feedback from the Activator to reduce sedentary behavior in older adultsParticipants 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. | Behavioural | Intervention group |
Primary outcome
Total sedentary behavior
Time frame: Pretest - posttest (4 weeks)
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.
Perceptions of (reducing) sedentary behavior
Time frame: Posttest (4 weeks)
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.
Domain-specific sedentary behavior
Time frame: Pretest - posttest (4 weeks)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 33970109Compernolle 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.
- Derived from this study: PubMed 33118951Compernolle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greet Cardon, Prof. study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults in people with Sedentary Lifestyle, run by VakgroepBewegingsEnSportwetenschappen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sedentary behavior (time frame: Pretest - posttest (4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.