NCT00294268

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 3, 2008

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

February 16, 2006

Last Update Submit

July 1, 2008

Conditions

Obesity

Keywords

obesityCBTmotivational enhancement therapyweight loss maintenance

Outcome Measures

Primary Outcomes (1)

  • Weight

    baseline, post-treatment, one-year follow-up

Secondary Outcomes (1)

  • obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance

    baseline, post-treatment, one-year follow-up

Study Arms (1)

1

OTHER

20 weekly sessions of CBT integrated with motivational enhancement strategies

Behavioral: cognitive behavioural therapy

Interventions

cognitive behavioural therapyBEHAVIORAL

20 weekly sessions of CBT integrated with motivational enhancement strategies

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participants will be recruited from among patients referred to the Metabolism and Obesity Service of Royal Prince Alfred Hospital.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolism and Obesity Services, Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Obesity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Elizabeth Rieger, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 3, 2008

Record last verified: 2008-07

Locations

AU(1)