Obesity Clinical Trial
Official title:
E-support for Healthcare Processes - WEIGHT LOSS
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Slovenia | CINDI Slovenia, National Institute of Public Health | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University of Primorska | National Institute of Public Health, Slovenia |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss | Weight loss of 5 to 10 % of the body mass at the beginning of the study | 16 weeks | No |
Secondary | Successful maintenance or improvement of the following measured parameter: Body mass index. | 16 weeks | No | |
Secondary | Successful maintenance or improvement of the following measured parameter: waist circumference | 16 weeks | No |
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