MedDataX Logo

E-support for Healthcare Processes - WEIGHT LOSS

NCT ID: NCT01716325

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Weight loss - ICT support

Weight loss - ICT support

Group Type EXPERIMENTAL

Self-management weight loss plan endorsement.

Intervention Type OTHER

Self-management weight loss plan endorsement.

Conventional

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

Group Type OTHER

Conventional

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-management weight loss plan endorsement.

Self-management weight loss plan endorsement.

Intervention Type OTHER

Conventional

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Public Health, Slovenia

OTHER_GOV

Sponsor Role collaborator

University of Primorska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cirila Hlastan Ribič, PhD, Prof.

Role: PRINCIPAL_INVESTIGATOR

National Institute of public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CINDI Slovenia, National Institute of Public Health

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Slovenia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cirila Hlastan Ribič, PhD, Prof.

Role: CONTACT

Phone: +386 1 5477372

Email: [email protected]

Iztok Cukjati

Role: CONTACT

Phone: +386 40 186 268

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cirila Hlastan Ribič, PhD, Prof.

Role: primary

Breda Cus

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EHOW

Identifier Type: -

Identifier Source: org_study_id