E-support for Healthcare Processes - WEIGHT LOSS

Study Overview
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Brief Summary
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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
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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.

Official Title
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E-support for Healthcare Processes - WEIGHT LOSS

Conditions
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Obesity

Intervention / Treatment
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* Other: Self-management weight loss plan endorsement.
* Other: Conventional


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss - ICT support<br>Weight loss - ICT support | Other: Self-management weight loss plan endorsement.<br>* Self-management weight loss plan endorsement.<br>|
| Other: Conventional<br>Weight loss, comparator - no ICT support; conventional live workshops for weight loss | Other: Conventional<br>* Weight loss, comparator - no ICT support; conventional live workshops for weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss of 5 to 10 % of the body mass at the beginning of the study | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful maintenance or improvement of the following measured parameter: Body mass index. |  | 16 weeks | 
| Successful maintenance or improvement of the following measured parameter: waist circumference |  | 16 weeks |