Clinical trial NCT01716325: E-support for Healthcare Processes - WEIGHT LOSS
Official title: E-support for Healthcare Processes - WEIGHT LOSS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, Slovenia
First posted: 2012-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 16 weeks
Secondary outcomes:
measure: Successful maintenance or improvement of the following measured parameter: Body mass index.
timeFrame: 16 weeks
measure: Successful maintenance or improvement of the following measured parameter: waist circumference
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: CINDI Slovenia, National Institute of Public Health
Study officials:
affiliation: National Institute of public Health
name: Cirila Hlastan Ribič, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: