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E-support for Healthcare Processes - WEIGHT LOSS

E-support for Healthcare Processes - WEIGHT LOSS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01716325
Enrollment
60
Registered
2012-10-29
Start date
2012-02-29
Completion date
2013-04-30
Last updated
2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHERSelf-management weight loss plan endorsement.

Self-management weight loss plan endorsement.

OTHERConventional

Weight loss, comparator - no ICT support; conventional live workshops for weight loss

Sponsors

National Institute of Public Health, Slovenia
CollaboratorOTHER_GOV
University of Primorska
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss16 weeksWeight loss of 5 to 10 % of the body mass at the beginning of the study

Secondary

MeasureTime 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 circumference16 weeks

Countries

Slovenia

Contacts

Primary ContactCirila Hlastan Ribič, PhD, Prof.
cirila.hlastan@ivz-rs.si+386 1 5477372
Backup ContactIztok Cukjati
iztok.cukjati@upr.si+386 40 186 268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026