Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000341921
Ethics application status
Approved
Date submitted
31/03/2011
Date registered
31/03/2011
Date last updated
31/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Simple Energy Technique in the Treatment of Food Cravings in Overweight Individuals
Scientific title
The use of Simple Energy Technique (SET) in the treatment of overweight individuals experiencing food cravings to study whether the use of SET is efficacious in reducing food cravings.
Secondary ID [1] 259890 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food cravings in overweight individuals 265490 0
Condition category
Condition code
Diet and Nutrition 265640 265640 0 0
Obesity
Mental Health 265643 265643 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SET will be delivered delivered by a Masters Level Counselling Psychology student who has attended the relevant SET training required to facilitate the treatment program. The program will involve 4 sessions, each of two hours in length over a period of four weeks. SET involves the combination of traditional talking psychotherapy and the tapping of acupressure points on the hands and face. Individuals are instructed on how to tap the points on themselves.
Intervention code [1] 264316 0
Behaviour
Intervention code [2] 264319 0
Treatment: Other
Comparator / control treatment
No Treatment. Waitlist Control Group. The control group will given treatment after a period of four weeks. This period matches the duration of the treatment groups program participation.
Control group
Active

Outcomes
Primary outcome [1] 262434 0
Changes in the experience of food cravings as measured by the Food Craving Inventory
Timepoint [1] 262434 0
pre and post treatment and at 3 months followup after treatment
Secondary outcome [1] 273771 0
Reduction in depression and anxiety as measured by the Depression Anxiety and Stress Scale (DASS)
Timepoint [1] 273771 0
pre and post treatment and at 3 months followup after treatment

Eligibility
Key inclusion criteria
Experiencing food cravings
being obese or overweight - 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?
No
Key exclusion criteria
1) diagnosis of anorexia and/or bulimia
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 eligable for participation in the research their names will be written on separate pieces of paper. These will then be placed in a container from which they will be drawn and placed into numbered containers assigned according to treatment or control group.
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] 264776 0
University
Name [1] 264776 0
Curtin University of Technology
Country [1] 264776 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street Bentley
Perth Western Australia 6102
Country
Australia
Secondary sponsor category [1] 263893 0
None
Name [1] 263893 0
Address [1] 263893 0
Country [1] 263893 0
Other collaborator category [1] 251920 0
Individual
Name [1] 251920 0
Dr Jenny Thornton
Address [1] 251920 0
Curtin University of Technology
Kent Street Bentley
Perth Western Australia 6102
Country [1] 251920 0
Australia
Other collaborator category [2] 251921 0
Individual
Name [2] 251921 0
Melissa Bell
Address [2] 251921 0
Curtin University of Technology
Kent Street Bentley
Perth Western Australia 6102
Country [2] 251921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266756 0
Curtin University of Technology Ethics Committee
Ethics committee address [1] 266756 0
Curtin University of Technology
Kent Street Bentley
Perth Western Australia 6102
Ethics committee country [1] 266756 0
Australia
Date submitted for ethics approval [1] 266756 0
Approval date [1] 266756 0
02/03/2011
Ethics approval number [1] 266756 0
HR 04/2011

Summary
Brief summary
This study will explore whether SET is an efficacious therapy in helping individuals manage food cravings
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32417 0
Address 32417 0
Country 32417 0
Phone 32417 0
Fax 32417 0
Email 32417 0
Contact person for public queries
Name 15664 0
Tanya Chiplin
Address 15664 0
38 Kimberley Street West Leederville
Perth Western Australia 6007
Country 15664 0
Australia
Phone 15664 0
+61 8 92006024
Fax 15664 0
Email 15664 0
[email protected]
Contact person for scientific queries
Name 6592 0
Tanya Chiplin
Address 6592 0
38 Kimberley Street West Leederville
Perth Western Australia 6007
Country 6592 0
Australia
Phone 6592 0
+61 8 92006024
Fax 6592 0
Email 6592 0
[email protected]

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.