A stAPP to a Healthier Lifestyle

December 2, 2014 updated by: Christophe Delecluse, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • people with mobility problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
use of application on smartphone for lifestyle counseling
innovative application on smartphone which helps to increase the awareness of sedentary behavior of the user by messages, scoring system, ...
No Intervention: control group
no use of application on smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sedentary behavior
Time Frame: Pre measurements after first week, post measurements after second week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability application
Time Frame: Post measurement after second week
Subjective questionnaire
Post measurement after second week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Christophe Delecluse, Prof Dr, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • S55635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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