NCT04003324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

19 days

First QC Date

March 13, 2019

Last Update Submit

June 28, 2019

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (1)

Intervention group

EXPERIMENTAL

Self-monitoring tool (Activator) and general information

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

Interventions

Op is Top - using feedback from the Activator to reduce sedentary behavior in older adultsBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be at least 60 years old
  • be Dutch-speaking
  • be able to walk 100 meters without severe difficulties
  • have a smartphone

You may not qualify if:

  • \- having functional limitations to stand up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 33970109DERIVED

  • 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.

    PMID: 33118951DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Greet Cardon, Prof.

    University Ghent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Department - Prof. Greet Cardon

Study Record Dates

First Submitted

March 13, 2019

First Posted

July 1, 2019

Study Start

April 19, 2019

Primary Completion

May 8, 2019

Study Completion

June 20, 2019

Last Updated

July 1, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)