Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000333910
Ethics application status
Approved
Date submitted
26/03/2011
Date registered
30/03/2011
Date last updated
30/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Use of Brief Cognitive Behavioural Therapy as a

Treatment for Food Cravings
Scientific title
The use of brief Cognitive Behavioural Therapy (CBT) with individuals experiencing food cravings to study whether the use of brief CBT will lower their experience of food cravings.
Secondary ID [1] 259824 0
NIl
Universal Trial Number (UTN)
U1111-1120-2097
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food cravings 265400 0
Cognitive behavioural therapy 265465 0
Condition category
Condition code
Diet and Nutrition 265559 265559 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Cognitive Behavioural Therapy will be delivered by a registered psychologist in a group format. The program will be made up of 4 sessions each two hours in length delivered once a week.
Intervention code [1] 264252 0
Behaviour
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 262362 0
Changes in cravings as measured by the food cravings inventory.
Timepoint [1] 262362 0
Before treatment, after treatment, and 3 months after completion of treatment.
Primary outcome [2] 262363 0
Changes in appetite for palatable foods measured by the power of food scale.
Timepoint [2] 262363 0
Before treatment, after treatment, and 3 months after completion of treatment.
Primary outcome [3] 262364 0
Changes in the tendency to be triggered by the presence of food cues to engage in overeating measured by the revised restraint scale
Timepoint [3] 262364 0
Before treatment, after treatment, and 3 months after completion of treatment.
Secondary outcome [1] 273635 0
Depression and Anxiety Stress Scale (DASS)
Timepoint [1] 273635 0
Before treatment, after treatment, and 3 months after completion of treatment.

Eligibility
Key inclusion criteria
Experiencing food cravings

Being overweight or obese - have a Body Mass Index (BMI) of 25 or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) eating disorder
2) psychotropic medication
3) Diabetes
4) Pregnant

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)
Once a suitable number of subjects have been determined to be eligible for participation in the research their names will be written on separate pieces of paper. These will then be placed into a container from which they will be drawn and placed into numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by drawing names 'out of a hat'.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264703 0
Self funded/Unfunded
Name [1] 264703 0
Country [1] 264703 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth
Western Australia. 6102
Country
Australia
Secondary sponsor category [1] 263835 0
None
Name [1] 263835 0
Address [1] 263835 0
Country [1] 263835 0
Other collaborator category [1] 251886 0
Individual
Name [1] 251886 0
Dr Jenny Thornton
Address [1] 251886 0
Curtin University,
Kent Street, Bentley, Perth
Western Australia. 6102
Country [1] 251886 0
Australia
Other collaborator category [2] 251887 0
Individual
Name [2] 251887 0
Tanya Chiplin
Address [2] 251887 0
Curtin University,
Kent Street, Bentley, Perth
Western Australia. 6102
Country [2] 251887 0
Australia
Other collaborator category [3] 251888 0
Individual
Name [3] 251888 0
Melissa Bell
Address [3] 251888 0
Curtin University,
Kent Street, Bentley, Perth
Western Australia. 6102
Country [3] 251888 0
Australia
Other collaborator category [4] 251889 0
Individual
Name [4] 251889 0
Dinah Shihata
Address [4] 251889 0
Curtin University,
Kent Street, Bentley, Perth
Western Australia. 6102
Country [4] 251889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266698 0
Curtin University Human Ethics Committee
Ethics committee address [1] 266698 0
Curtin University,
Kent Street, Bentley, Perth
Western Australia. 6102
Ethics committee country [1] 266698 0
Australia
Date submitted for ethics approval [1] 266698 0
Approval date [1] 266698 0
02/03/2011
Ethics approval number [1] 266698 0
HR 06/2011

Summary
Brief summary
The study will look at whether brief cognitive therapy is effective in helping individuals deal with food cravings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32363 0
Address 32363 0
Country 32363 0
Phone 32363 0
Fax 32363 0
Email 32363 0
Contact person for public queries
Name 15610 0
bart wszola
Address 15610 0
38 Kimberley Street West Leederville,
Western Australia 6007
Country 15610 0
Australia
Phone 15610 0
61 0467 545 491
Fax 15610 0
Email 15610 0
foodcravings2011@yahoo.com.au
Contact person for scientific queries
Name 6538 0
bart wszola
Address 6538 0
38 kimberley street west leederville, western australia 6007
Country 6538 0
Australia
Phone 6538 0
61 8 9200 6024
Fax 6538 0
61 8 9200 6281
Email 6538 0
bart.wszola@westnet.com.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.