NCT01975870

Brief Summary

The main objective of the project is to make participants aware of their sedentary behavior (prolonged sitting behavior) and then to encourage behavioral change through the use of an innovative and fun application on a smartphone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

August 28, 2013

Last Update Submit

December 2, 2014

Conditions

Keywords

Sedentary behavior, smartphone, application

Outcome Measures

Primary Outcomes (1)

  • Change in sedentary behavior

    Objective sedentary behavior: measured by ActivPal (monitor) Subjective sedentary behavior: measured by subjective questionnaire

    Pre measurements after first week, post measurements after second week

Secondary Outcomes (1)

  • Usability application

    Post measurement after second week

Study Arms (2)

intervention group

EXPERIMENTAL

use of application on smartphone for lifestyle counseling

Other: Application on smartphone

control group

NO INTERVENTION

no use of application on smartphone

Interventions

innovative application on smartphone which helps to increase the awareness of sedentary behavior of the user by messages, scoring system, ...

intervention group

Eligibility Criteria

Age19 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 19-59 years
  • participants must own a smartphone
  • participants have a sedentary lifestyle (prolonged sitting attitude)

You may not qualify if:

  • people with mobility problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Related Publications (6)

  • Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exerc Sport Sci Rev. 2010 Jul;38(3):105-13. doi: 10.1097/JES.0b013e3181e373a2.

  • Dunstan DW, Howard B, Healy GN, Owen N. Too much sitting--a health hazard. Diabetes Res Clin Pract. 2012 Sep;97(3):368-76. doi: 10.1016/j.diabres.2012.05.020. Epub 2012 Jun 9.

  • Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, Owen N. Breaks in sedentary time: beneficial associations with metabolic risk. Diabetes Care. 2008 Apr;31(4):661-6. doi: 10.2337/dc07-2046. Epub 2008 Feb 5.

  • Rutten GM, Savelberg HH, Biddle SJ, Kremers SP. Interrupting long periods of sitting: good STUFF. Int J Behav Nutr Phys Act. 2013 Jan 2;10:1. doi: 10.1186/1479-5868-10-1.

  • Swartz AM, Squires L, Strath SJ. Energy expenditure of interruptions to sedentary behavior. Int J Behav Nutr Phys Act. 2011 Jun 27;8:69. doi: 10.1186/1479-5868-8-69.

  • Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christophe Delecluse, Prof Dr

    KU Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Professor Christophe Delecluse

Study Record Dates

First Submitted

August 28, 2013

First Posted

November 5, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations