E-support for Healthcare Processes - WEIGHT LOSS
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 29, 2012
October 1, 2012
10 months
October 24, 2012
October 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss
Weight loss of 5 to 10 % of the body mass at the beginning of the study
16 weeks
Secondary Outcomes (2)
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
Study Arms (2)
Weight loss - ICT support
EXPERIMENTALWeight loss - ICT support
Conventional
OTHERWeight loss, comparator - no ICT support; conventional live workshops for weight loss
Interventions
Self-management weight loss plan endorsement.
Weight loss, comparator - no ICT support; conventional live workshops for weight loss
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CINDI Slovenia, National Institute of Public Health
Ljubljana, 00386, Slovenia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cirila Hlastan Ribič, PhD, Prof.
National Institute of public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 29, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
October 29, 2012
Record last verified: 2012-10