ObesityNCT01716325
E-support for Healthcare Processes - WEIGHT LOSS
A study testing Self-management weight loss plan endorsement. and Conventional in people with Obesity, run by University of Primorska at 1 site in Slovenia.
Trial summary
The purpose of the study is to establish and clinically evaluate a new approach to treating obesity by using information and communication technologies (ICT). A mobile environment and organizational interventions to improve the process of an integrated treatment of people with obesity will be identified, developed… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Self-management weight loss plan endorsement. and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- Feb 2012to Apr 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI≥30 or BMI>27,5 and 20% or more risk for developing a cardiovascular diseases
- Age between 25 - 65 years for men and 25 - 70 years for women
- Own a mobile phone
- Internet
- Know how to use a computer
- Know how to use an e-mail
- Signed voluntary consent to participate in the survey
Who cannot join
- People with movement disorders
- Age<18 years or age>70 years for women and 65 years for men
- Pregnancy, breast feeding, intention of getting pregnant during the study, period after childbirth (9 months)
- Does not own or know how to handle a mobile phone
- No internet access
- Known hospitalization for severe psychiatric disorders (schizophrenia, psychosis)
Show all 11Show fewer
- Known history of eating disorders (anorexia, bulimia nervosa and others)
- Cancer incidence in the last 5 years
- Heart problems, chest pain, nausea, dizziness
- Chronic inflammatory diseases
- Other unregulated chronic diseases
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
CINDI Slovenia, National Institute of Public Health
Ljubljana, 00386
Cirila Hlastan Ribič, PhD, Prof., +386 1 5477372, cirila.hlastan@ivz-rs.si
Breda Cus, +386 1 5477368, breda.cus@ivz-rs.si
About this study
The purpose of the study is to establish and clinically evaluate a new approach to treating obesity by using information and communication technologies (ICT). A mobile environment and organizational interventions to improve the process of an integrated treatment of people with obesity will be identified, developed, introduced and clinically evaluated.
Read the detailed description
A mobile environment to improve the process of an integrated treatment of obese people will be identified, developed, introduced and clinically evaluated. The study will include 150 patients aged between 25 to 65 for men and 25 to 70 for women, diagnosed with obesity (BMI≥30 or BMI>27,5 and 20% risk or more for developing a cardiovascular diseases). One group of patients will visit conventional live workshops for weight loss and the other group will use ICT. At the initial examination by the doctor all survey participants will have measured blood pressure, body mass, waist circumference, percentage of body fat, percentage of skeletal muscle, resting metabolic rate, estimated risk of developing cardiovascular disease and will be directed to laboratory examination (blood lipids and cholesterol, blood sugar). Both groups will go through 16 workshops for weight loss. Each week they will monitor their body mass, waist circumference, physical activity (type, duration, intensity) and food intake (type, quantity). After six months all survey participants will be examined again. We will compare effectiveness of ICT weight loss group with conventional weight loss group.
- Conditions
- Obesity
- Being tested
- Self-management weight loss plan endorsement., Conventional
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management weight loss plan endorsement.Other
Self-management weight loss plan endorsement.
ConventionalOther
Weight loss, comparator - no ICT support; conventional live workshops for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Weight loss - ICT support | Experimental | Weight loss - ICT support Receives: Other: Self-management weight loss plan endorsement. |
| Conventional | Other | Weight loss, comparator - no ICT support; conventional live workshops for weight loss Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss of 5 to 10 % of the body mass at the beginning of the study
Measured: 16 weeks
Secondary outcomes (2)
Successful maintenance or improvement of the following measured parameter: Body mass index.
Measured: 16 weeks
Successful maintenance or improvement of the following measured parameter: waist circumference
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia
- Responsible party
- Sponsor
- Investigators
- Cirila Hlastan Ribič, PhD, Prof., Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716325
- Sponsor's protocol ID
- EHOW
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-support for Healthcare Processes - WEIGHT LOSS
- ClinicalTrials.gov ID
- NCT01716325
- Acronym / sponsor ID
- EHOW
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 29 Oct 2012 (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 the study is to establish and clinically evaluate a new approach to treating obesity by using information and communication technologies (ICT). A mobile environment and organizational interventions to improve the process of an integrated treatment of people with obesity will be identified, developed, introduced and clinically evaluated.
Detailed description
A mobile environment to improve the process of an integrated treatment of obese people will be identified, developed, introduced and clinically evaluated. The study will include 150 patients aged between 25 to 65 for men and 25 to 70 for women, diagnosed with obesity (BMI≥30 or BMI>27,5 and 20% risk or more for developing a cardiovascular diseases). One group of patients will visit conventional live workshops for weight loss and the other group will use ICT. At the initial examination by the doctor all survey participants will have measured blood pressure, body mass, waist circumference, percentage of body fat, percentage of skeletal muscle, resting metabolic rate, estimated risk of developing cardiovascular disease and will be directed to laboratory examination (blood lipids and cholesterol, blood sugar). Both groups will go through 16 workshops for weight loss. Each week they will monitor their body mass, waist circumference, physical activity (type, duration, intensity) and food intake (type, quantity). After six months all survey participants will be examined again. We will compare effectiveness of ICT weight loss group with conventional weight loss group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss - ICT support | Experimental | Other: Self-management weight loss plan endorsement.Weight loss - ICT support |
| Conventional | Other | Other: ConventionalWeight loss, comparator - no ICT support; conventional live workshops for weight loss |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI≥30 or BMI>27,5 and 20% or more risk for developing a cardiovascular diseases
- Age between 25 - 65 years for men and 25 - 70 years for women
- Own a mobile phone
- Internet
- Know how to use a computer
Key exclusion criteria (11 listed)
- People with movement disorders
- Age<18 years or age>70 years for women and 65 years for men
- Pregnancy, breast feeding, intention of getting pregnant during the study, period after childbirth (9 months)
- Does not own or know how to handle a mobile phone
- No internet access
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 |
|---|---|---|
| Self-management weight loss plan endorsement.Self-management weight loss plan endorsement. | Other | Weight loss - ICT support |
| ConventionalWeight loss, comparator - no ICT support; conventional live workshops for weight loss | Other | Conventional |
Primary outcome
Weight loss
Time frame: 16 weeks
Weight loss of 5 to 10 % of the body mass at the beginning of the study
2 secondary outcomes
Successful maintenance or improvement of the following measured parameter: Body mass index.
Time frame: 16 weeks
Successful maintenance or improvement of the following measured parameter: waist circumference
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
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Obesity
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.
Cirila Hlastan Ribič, PhD, Prof. principal investigator
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management weight loss plan endorsement. and Conventional in people with Obesity, run by University of Primorska at 1 site in Slovenia.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Oct 2012. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cirila Hlastan Ribič, PhD, Prof. (+386 1 5477372, cirila.hlastan@ivz-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2012.