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Sedentary LifestyleNCT01975870

A stAPP to a Healthier Lifestyle

A study testing Application on smartphone in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Sedentary Lifestyle
What is being tested?
Application on smartphone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
Sep 2013to Jul 2014
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 19 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • people with mobility problems

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • KU Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

About this study

Official title: A stAPP to a Healthier Lifestyle: a Randomized Controlled Trial

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.

Read the detailed description

Recent scientific research has shown that prolonged sitting, also called sedentary behavior may have adverse effects on health. An increased negative association was found with cardio-metabolic risk factors, type 2 diabetes and premature mortality.

The occurrence of these adverse health effects even appears to be independently of the degree of physical activity. There is more and more evidence to interrupt prolonged sitting regularly.

Until today there is still no international scientific standard that specifies how often the sitting behavior should be interrupted. Moreover, it is also unclear how long the breaks should take to counter adverse health effects. Only a few studies examined the health effects after an intervention that aimed to reduce the sitting behavior.

Currently, there is a great need for interventions in which one is made aware of the problem of sedentarity, but by which, one is equally encouraged changing behavior in the short as well as long term. In the proposed project the investigators therefore contribute to a good method to fight sedentary behavior in an innovative way. The investigators will try to achieve that goal through the development and implementation of an application on the smartphone.

Recent figures show that it is impossible to ignore the existence of the smartphone with all its applications. In 2011 40.4% of the Flemish people owned a smartphone. In the same year 650 000 smartphones were sold in Belgium. In 2012, according to projections this number should be increased by 250% to 1.625 000.

The smartphone is a very popular tool that can be used for the adoption of a healthy lifestyle. There are meanwhile a lot of sport and exercise apps that measure physical activity (eg Runkeeper Pro or Fitness Builder) and give more information around physical activity. Motion sensors, which are standard built-in in a smartphone, are often used for this purpose.

In the development of the app and the associated processes in this project, the principles of Self Determination Theory (SDT) are taken into account. This theoretical framework makes it possible to aim for a change in behavior in the short and in the long term.

During the development of the app, the investigators respect the sense of autonomy, competence and social connectedness of the user. Recent research showed already that applications which generate awareness and at regular intervals supply reminders, and this while autonomy and trust in their own competencies are respected, are effective in reducing sedentary behavior.

The effectiveness of the application will be investigated by means of a controlled intervention study. In this study, a control- and intervention group of 30 participants are included.

At the beginning of the project, both the intervention group and the control group will fill in some scientific questionnaires about sedentary behavior (pre-test).

  1. st week: During one week, both the control- and the intervention group will wear an activity monitor (ActivPal). In this way, the investigators can determine the degree of physical activity and sedentary behavior.
  2. nd week: After this week, the control group is asked not to change lifestyle. The persons of the control group still wear the activity monitor. The intervention group can use the app for a week and at the same time the persons of the intervention group have to carry the activity monitor. They can choose how they use the application (as they prefer, depending on the profile eg no advice versus daily advice received).

After the 2nd week, both the control and the intervention group are invited and fill in the questionnaire (post-test). Data from the activity monitor are retrieved. Now the investigators can examine if sedentary behavior of the intervention group was significantly decreased by the use of the app, compared to the sedentary behavior of the control group. Moreover, the investigators will also examine whether the way of use of the app (cfr profile) has an effect on the result.

Being tested
Application on smartphone
Keywords
Sedentary behavior, smartphone, application
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application on smartphoneOther

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

Study groups in NCT01975870
Study groupRoleWhat they receive
intervention groupExperimentaluse of application on smartphone for lifestyle counseling
Receives: Other: Application on smartphone
control groupNo interventionno use of application on smartphone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sedentary behavior

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

    Measured: Pre measurements after first week, post measurements after second week

Secondary outcomes (1)
  1. Usability application

    Subjective questionnaire

    Measured: Post measurement after second week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975870
Sponsor's protocol ID
S55635
Status last verified
Dec 2014
First submitted
28 Aug 2013
Last updated
3 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20577058
  • 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.

    PubMed 22682948
  • 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.

    PubMed 18252901
  • 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.

    PubMed 23281722
  • 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.

    PubMed 21708007
  • 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.

    PubMed 11392867

Questions about this trial

What is this clinical trial studying?

A study testing Application on smartphone in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven 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 3 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 3 Dec 2014. 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?

Change in sedentary behavior (time frame: Pre measurements after first week, post measurements after second week). 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 NCT01975870, which also lists 6 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 3 Dec 2014.

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