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E-support for Healthcare Processes - WEIGHT LOSS

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ClinicalTrials.gov Identifier: NCT01716325
Recruitment Status : Unknown
Verified October 2012 by University of Primorska.
Recruitment status was:  Recruiting
First Posted : October 29, 2012
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: E-support for Healthcare Processes - WEIGHT LOSS
Study Start Date : February 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Weight loss - ICT support
Weight loss - ICT support
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
Other: Conventional
Weight loss, comparator - no ICT support; conventional live workshops for weight loss


Outcome Measures

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 16 weeks ]
    Weight loss of 5 to 10 % of the body mass at the beginning of the study


Secondary Outcome Measures :
  1. Successful maintenance or improvement of the following measured parameter: Body mass index. [ Time Frame: 16 weeks ]
  2. Successful maintenance or improvement of the following measured parameter: waist circumference [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716325


Contacts
Contact: Cirila Hlastan Ribič, PhD, Prof. +386 1 5477372 cirila.hlastan@ivz-rs.si
Contact: Iztok Cukjati +386 40 186 268 iztok.cukjati@upr.si

Locations
Slovenia
CINDI Slovenia, National Institute of Public Health Recruiting
Ljubljana, Slovenia, 00386
Contact: Cirila Hlastan Ribič, PhD, Prof.    +386 1 5477372    cirila.hlastan@ivz-rs.si   
Contact: Breda Cus    +386 1 5477368    breda.cus@ivz-rs.si   
Sub-Investigator: Ana Šerona         
Sponsors and Collaborators
University of Primorska
National Institute of Public Health, Slovenia
Investigators
Principal Investigator: Cirila Hlastan Ribič, PhD, Prof. National Institute of public Health
More Information

Responsible Party: University of Primorska
ClinicalTrials.gov Identifier: NCT01716325     History of Changes
Other Study ID Numbers: EHOW
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms