ObesityNCT02438059
SoSu-liv. Mobile Media for Health Promotion
A study testing SoSu-liv website and app in people with Obesity, run by University of Copenhagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- SoSu-liv website and app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees working under a FOA (a Danish union) agreement in elderly care in Denmark.
Who cannot join
- Pregnancy
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- SoSu-liv website and app
- Keywords
- Inequality in health, workplace health promotion, internet, mobile app, weight loss, intervention, randomized controlled trial
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoSu-liv website and appBehavioural
A 38 weeks web- and app-based tool for lifestyle changes intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to the SoSu-liv website and app for 38 weeks. Receives: Behavioral: SoSu-liv website and app |
| Control | No intervention | No treatment for 38 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 38 weeks
Secondary outcomes (5)
Body fat percentage (Measured using a bioelectrical impedance)
Measured using a bioelectrical impedance
Measured: 38 weeks
Waist circumference
Measured: 38 weeks
Blood pressure
Measured: 38 weeks
Cholesterol
Capillary whole blood total cholesterol (measured using bedside equipment)
Measured: 38 weeks
Blood sugar
Capillary whole blood glucose (measured using bedside equipment)
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- PenSam, Denmark, Mobile Fitness A/S
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438059
- Sponsor's protocol ID
- B283
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balk-Moller NC, Poulsen SK, Larsen TM. Effect of a Nine-Month Web- and App-Based Workplace Intervention to Promote Healthy Lifestyle and Weight Loss for Employees in the Social Welfare and Health Care Sector: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e108. doi: 10.2196/jmir.6196.
PubMed 28396303
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02438059
- Acronym / sponsor ID
- B283
- Conditions
- Obesity
- Keywords
- Inequality in health, workplace health promotion, internet, mobile app, weight loss, intervention, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- PenSam, Denmark, Mobile Fitness A/S
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SoSu-liv website and appAccess to the SoSu-liv website and app for 38 weeks. |
| Control | No intervention | –No treatment for 38 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees working under a FOA (a Danish union) agreement in elderly care in Denmark.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoSu-liv website and appA 38 weeks web- and app-based tool for lifestyle changes intervention. | Behavioural | Intervention |
Primary outcome
Body weight
Time frame: 38 weeks
5 secondary outcomes
Body fat percentage (Measured using a bioelectrical impedance)
Time frame: 38 weeks
Waist circumference
Time frame: 38 weeks
Blood pressure
Time frame: 38 weeks
Cholesterol
Time frame: 38 weeks
Blood sugar
Time frame: 38 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Derived from this study: PubMed 28396303Balk-Moller NC, Poulsen SK, Larsen TM. Effect of a Nine-Month Web- and App-Based Workplace Intervention to Promote Healthy Lifestyle and Weight Loss for Employees in the Social Welfare and Health Care Sector: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e108. doi: 10.2196/jmir.6196.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor study director
Head of Department
Questions about this trial
What is this clinical trial studying?
A study testing SoSu-liv website and app in people with Obesity, run by University of Copenhagen.
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 1 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Body weight (time frame: 38 weeks). 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 NCT02438059, which also lists 1 linked publication.
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 8 May 2015.