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SoSu-liv. Mobile Media for Health Promotion

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ClinicalTrials.gov Identifier: NCT02438059
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Collaborators:
PenSam, Denmark
Mobile Fitness A/S
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:
The purpose of this study is to determine whether a web- and app-based tool for health promotion for social and health care workers in Denmark has an effect on body weight (primary outcome), body fat percentage, waist circumference, blood pressure, cholesterol and blood sugar in a 38 week intervention period.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: SoSu-liv website and app Not Applicable

Detailed Description:

The study was conducted in six municipalities in Denmark from August 2012 - July 2013. In each municipality two to four nursing homes were randomized to either having access to the SoSu-liv tool for 38 weeks, or act as a controls group, that did not receive any treatment. Those municipalities with an even number of nursing homes were randomized in a 1:1 ratio and municipalities with an odd number of nursing homes in a 2:1 ratio. Twelve out of a total of 20 nursing homes were randomized to SoSu-liv, and 8 were randomized to control. The study was divided into two distinct periods. An initial 16 week period including a team competition among the participating nursing homes using the SoSu-liv tool, and a subsequent 22 week period without a competition.

An information meeting was held at each nursing home during work hours, after which each of the employees who was interested in participating completed the consent form. At the baseline examination taking place a few weeks after, the participants underwent a clinical examination (anthropometry, blood pressure and blood sampling values ), and were subsequently introduced to the SoSu-liv tool, altogether taking up 30-45 minutes. After 16 weeks, the clinical examination was repeated, taking about 15 minutes in total. An identical procedure was applied after the total of 38 weeks. The day before each of the 3 clinical examinations, the participants had to spend approximately 10-15 minutes answering an online questionnaire regarding demographic data, health behaviour and general well-being.

The SoSu-liv tool is a web- and app-based tool developed specifically for this particular group of employees. The program has several social features that encourage the users to interact with each other both digitally, physically and orally at the work place. A general overview of the SoSu-life tool is best given by differentiate the tool into four different sections. The social section is an interactive part making it possible to interact with other colleagues using the program. It includes features to send short messages and challenges to other colleagues, join groups and post messages in discussion forums. The functional section is the practical interactive part. It includes features of food registration (calorie counting), exercise registration, establishing new habits, service of text messages-reminders, and the possibility of emailing a question to an expert. The personal section is where the user can track changes in self-reported variables, such as body weight, waist circumference as well as daily amount of smoked cigarettes, and daily general well-being. Other features of the tool include quizzes, health relevant tests, food recipes and food-cinema, as well as a number of information pages on health. Furthermore, the SoSu-liv-tool used a point system where most of the activities performed using the tool gave points to the individual user. During the first 16 weeks, each nursing home formed a team of participants, and each of the users' individual points were added to the teams' total points. For every point collected by the nursery team, a ticket was generated to the team and put in a draw pool. Each month, the team had a chance to win a price by simple draw. The team with the most points after 16 weeks also won a price. In the last 22 week intervention period, points were still collected, but no prices were provided.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SoSu-liv. A Web- and App-based Intervention Study for Health Promotion Among Social and Health Care Workers in Denmark. A Randomized Controlled Trial
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: Intervention
Access to the SoSu-liv website and app for 38 weeks.
Behavioral: SoSu-liv website and app
A 38 weeks web- and app-based tool for lifestyle changes intervention.

No Intervention: Control
No treatment for 38 weeks.



Primary Outcome Measures :
  1. Body weight [ Time Frame: 38 weeks ]

Secondary Outcome Measures :
  1. Body fat percentage (Measured using a bioelectrical impedance) [ Time Frame: 38 weeks ]
    Measured using a bioelectrical impedance

  2. Waist circumference [ Time Frame: 38 weeks ]
  3. Blood pressure [ Time Frame: 38 weeks ]
  4. Cholesterol [ Time Frame: 38 weeks ]
    Capillary whole blood total cholesterol (measured using bedside equipment)

  5. Blood sugar [ Time Frame: 38 weeks ]
    Capillary whole blood glucose (measured using bedside equipment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Employees working under a FOA (a Danish union) agreement in elderly care in Denmark.

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438059


Sponsors and Collaborators
University of Copenhagen
PenSam, Denmark
Mobile Fitness A/S
Investigators
Study Director: Arne Astrup, Professor Head of Department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arne Astrup, Professor and Head of Department, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02438059     History of Changes
Other Study ID Numbers: B283
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Arne Astrup, University of Copenhagen:
Inequality in health
workplace health promotion
internet
mobile app
weight loss
intervention
randomized controlled trial