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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00294268




Registration number
NCT00294268
Ethics application status
Date submitted
16/02/2006
Date registered
20/02/2006
Date last updated
3/07/2008

Titles & IDs
Public title
Cognitive Behavioural Therapy for Obesity
Scientific title
A Maintenance-Oriented Cognitive Behavioural Therapy in the Treatment of Obesity
Secondary ID [1] 0 0
erie8202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - cognitive behavioural therapy

Other: 1 - 20 weekly sessions of CBT integrated with motivational enhancement strategies


BEHAVIORAL: cognitive behavioural therapy
20 weekly sessions of CBT integrated with motivational enhancement strategies
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight
Timepoint [1] 0 0
baseline, post-treatment, one-year follow-up
Secondary outcome [1] 0 0
obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance
Timepoint [1] 0 0
baseline, post-treatment, one-year follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Metabolism and Obesity Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Rieger, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00294268