- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294268
Cognitive Behavioural Therapy for Obesity
July 1, 2008 updated by: University of Sydney
A Maintenance-Oriented Cognitive Behavioural Therapy in the Treatment of Obesity
The purpose of this study is to evaluate the effectiveness of a cognitive behavioural treatment (CBT) designed to help obese patients lose weight and to maintain their weight losses over time.
It is hypothesized that CBT will result in greater sustained weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary aim of the present study is to improve the maintenance of weight loss, and hence the physical, psychological and social well-being, of obese patients who have sought weight loss treatment.
To do so, it will implement a cognitive-behavioural treatment (CBT) with motivational enhancement strategies specifically designed to target weight maintenance.
It is hypothesized that the maintenance-oriented CBT approach will result in sustained weight loss, as well as improved physical, psychological and social well-being.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2050
- Metabolism and Obesity Services, Royal Prince Alfred Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participants will be recruited from among patients referred to the Metabolism and Obesity Service of Royal Prince Alfred Hospital.
- The inclusion criteria include: 18-65 years of age and a body mass index (BMI: kg/m2) between 30-45.
Exclusion Criteria:
- psychiatric conditions (i.e., current psychosis, severe depression, mental retardation, and drug or alcohol abuse)
- or physical conditions (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke and transient ischaemic attacks) that would preclude full participation in the study;
- current treatment for obesity;
- current treatments known to affect eating or weight (e.g., medications);
- pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
20 weekly sessions of CBT integrated with motivational enhancement strategies
|
20 weekly sessions of CBT integrated with motivational enhancement strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight
Time Frame: baseline, post-treatment, one-year follow-up
|
baseline, post-treatment, one-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance
Time Frame: baseline, post-treatment, one-year follow-up
|
baseline, post-treatment, one-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Rieger, PhD, University of Sydney
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
February 16, 2006
First Submitted That Met QC Criteria
February 16, 2006
First Posted (Estimate)
February 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 3, 2008
Last Update Submitted That Met QC Criteria
July 1, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- erie8202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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