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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Behaviour - cognitive behavioural therapy

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


Behaviour: cognitive behavioural therapy
20 weekly sessions of CBT integrated with motivational enhancement strategies
Intervention code [1] 0 0
Behaviour
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00294268
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00294268