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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04003324
Other study ID # Op is Top - Pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2019
Est. completion date June 20, 2019

Study information

Verified date June 2019
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 20, 2019
Est. primary completion date May 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults
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.

Locations

Country Name City State
Belgium Ghent University Ghent Oost-Vlaanderen

Sponsors (2)

Lead Sponsor Collaborator
VakgroepBewegingsEnSportwetenschappen University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pretest - posttest (4 weeks)
Primary 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. Posttest (4 weeks)
Primary 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. Pretest - posttest (4 weeks)
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