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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Other: Self-management weight loss plan endorsement.; Other: Conventional

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 00386
    • Recruiting
    • CINDI Slovenia, National Institute of Public Health
    • Contact: Cirila Hlastan Ribič, PhD, Prof.; Phone Number: +386 1 5477372; Email: cirila.hlastan@ivz-rs.si
    • Contact: Breda Cus; Phone Number: +386 1 5477368; Email: breda.cus@ivz-rs.si
    • Sub-Investigator: Ana Šerona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Weight loss - ICT support	Other: Self-management weight loss plan endorsement.; Self-management weight loss plan endorsement.
OTHER: Conventional; Weight loss, comparator - no ICT support; conventional live workshops for weight loss	Other: Conventional; Weight loss, comparator - no ICT support; conventional live workshops for weight loss

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: National Institute of Public Health, Slovenia
• Investigators: Principal Investigator: Cirila Hlastan Ribič, PhD, Prof., National Institute of Public Health

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (ESTIMATE): October 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: EHOW