- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438059
SoSu-liv. Mobile Media for Health Promotion
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 Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Employees working under a FOA (a Danish union) agreement in elderly care in Denmark.
Exclusion Criteria:
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Access to the SoSu-liv website and app for 38 weeks.
|
A 38 weeks web- and app-based tool for lifestyle changes intervention.
|
NO_INTERVENTION: Control
No treatment for 38 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight
Time Frame: 38 weeks
|
38 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat percentage (Measured using a bioelectrical impedance)
Time Frame: 38 weeks
|
Measured using a bioelectrical impedance
|
38 weeks
|
Waist circumference
Time Frame: 38 weeks
|
38 weeks
|
|
Blood pressure
Time Frame: 38 weeks
|
38 weeks
|
|
Cholesterol
Time Frame: 38 weeks
|
Capillary whole blood total cholesterol (measured using bedside equipment)
|
38 weeks
|
Blood sugar
Time Frame: 38 weeks
|
Capillary whole blood glucose (measured using bedside equipment)
|
38 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arne Astrup, Professor, head of department
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B283
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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