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
About this trial
This is an interventional prevention trial for Obesity
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
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
NCT ID
NCT01716325
First Posted
October 24, 2012
Last Updated
October 24, 2012
Sponsor
University of Primorska
Collaborators
National Institute of Public Health, Slovenia
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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