E-support for Healthcare Processes - WEIGHT LOSS

Obesity Clinical Trial

Official title:

E-support for Healthcare Processes - WEIGHT LOSS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01716325
• Other study ID #: EHOW
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2012
• Last updated: October 24, 2012
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2012
• Source: University of Primorska
• Contact: Cirila Hlastan Ribic, PhD, Prof.
• Phone: +386 1 5477372
• Email: cirila.hlastan[@]ivz-rs.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical 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, introduced and clinically evaluated.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Self-management weight loss plan endorsement.
Self-management weight loss plan endorsement.
• Conventional
Weight loss, comparator - no ICT support; conventional live workshops for weight loss

Locations

Country	Name	City	State
Slovenia	CINDI Slovenia, National Institute of Public Health	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	National Institute of Public Health, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

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