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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00294268
Other study ID # erie8202
Secondary ID
Status Completed
Phase Phase 2
First received February 16, 2006
Last updated July 1, 2008
Start date March 2006
Est. completion date March 2008

Study information

Verified date July 2008
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive behavioural therapy
20 weekly sessions of CBT integrated with motivational enhancement strategies

Locations

Country Name City State
Australia Metabolism and Obesity Services, Royal Prince Alfred Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight baseline, post-treatment, one-year follow-up No
Secondary obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance baseline, post-treatment, one-year follow-up No
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