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E-support for Healthcare Processes - WEIGHT LOSS

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Self-management weight loss plan endorsement.
Conventional
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CINDI Slovenia, National Institute of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Weight loss - ICT support

Conventional

Arm Description

Weight loss - ICT support

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

Outcomes

Primary Outcome Measures

Weight loss
Weight loss of 5 to 10 % of the body mass at the beginning of the study

Secondary Outcome Measures

Successful maintenance or improvement of the following measured parameter: Body mass index.
Successful maintenance or improvement of the following measured parameter: waist circumference

Full Information

First Posted
October 24, 2012
Last Updated
October 24, 2012
Sponsor
University of Primorska
Collaborators
National Institute of Public Health, Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT01716325
Brief Title
E-support for Healthcare Processes - WEIGHT LOSS
Official Title
E-support for Healthcare Processes - WEIGHT LOSS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Primorska
Collaborators
National Institute of Public Health, Slovenia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight loss - ICT support
Arm Type
Experimental
Arm Description
Weight loss - ICT support
Arm Title
Conventional
Arm Type
Other
Arm Description
Weight loss, comparator - no ICT support; conventional live workshops for weight loss
Intervention Type
Other
Intervention Name(s)
Self-management weight loss plan endorsement.
Intervention Description
Self-management weight loss plan endorsement.
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
Weight loss, comparator - no ICT support; conventional live workshops for weight loss
Primary Outcome Measure Information:
Title
Weight loss
Description
Weight loss of 5 to 10 % of the body mass at the beginning of the study
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Successful maintenance or improvement of the following measured parameter: Body mass index.
Time Frame
16 weeks
Title
Successful maintenance or improvement of the following measured parameter: waist circumference
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cirila Hlastan Ribič, PhD, Prof.
Phone
+386 1 5477372
Email
cirila.hlastan@ivz-rs.si
First Name & Middle Initial & Last Name or Official Title & Degree
Iztok Cukjati
Phone
+386 40 186 268
Email
iztok.cukjati@upr.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cirila Hlastan Ribič, PhD, Prof.
Organizational Affiliation
National Institute of public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CINDI Slovenia, National Institute of Public Health
City
Ljubljana
ZIP/Postal Code
00386
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cirila Hlastan Ribič, PhD, Prof.
Phone
+386 1 5477372
Email
cirila.hlastan@ivz-rs.si
First Name & Middle Initial & Last Name & Degree
Breda Cus
Phone
+386 1 5477368
Email
breda.cus@ivz-rs.si
First Name & Middle Initial & Last Name & Degree
Ana Šerona

12. IPD Sharing Statement

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E-support for Healthcare Processes - WEIGHT LOSS

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