ObesityPhase 2NCT00294268
Cognitive Behavioural Therapy for Obesity
A Phase 2 study testing cognitive behavioural therapy in people with Obesity, run by University of Sydney at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Metabolism and Obesity Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- cognitive behavioural therapy
- Keywords
- obesity, CBT, motivational enhancement therapy, weight loss maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioural therapyBehavioural
20 weekly sessions of CBT integrated with motivational enhancement strategies
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 20 weekly sessions of CBT integrated with motivational enhancement strategies Receives: Behavioral: cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: baseline, post-treatment, one-year follow-up
Secondary outcomes (1)
obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance
Measured: baseline, post-treatment, one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Elizabeth Rieger, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294268
- Sponsor's protocol ID
- erie8202
- Status last verified
- Jul 2008
- First submitted
- 16 Feb 2006
- Last updated
- 3 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Maintenance-Oriented Cognitive Behavioural Therapy in the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT00294268
- Acronym / sponsor ID
- erie8202
- Conditions
- Obesity
- Keywords
- obesity, CBT, motivational enhancement therapy, weight loss maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: cognitive behavioural therapy20 weekly sessions of CBT integrated with motivational enhancement strategies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioural therapy20 weekly sessions of CBT integrated with motivational enhancement strategies | Behavioural | 1 |
Primary outcome
Weight
Time frame: baseline, post-treatment, one-year follow-up
1 secondary outcome
obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance
Time frame: baseline, post-treatment, one-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Rieger, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cognitive behavioural therapy in people with Obesity, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: baseline, post-treatment, one-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2008.