Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000231347
Ethics application status
Approved
Date submitted
30/04/2008
Date registered
6/05/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the Emotional Freedom Technique (EFT) for reducing food cravings
Scientific title
Evaluation of the Emotional Freedom Technique (EFT) versus Waitlist for Reducing Food Cravings: A Randomized Clinical Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
food cravings 3095 0
Condition category
Condition code
Diet and Nutrition 3254 3254 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EFT combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. The technique to be used is called The Emotional Freedom technique (EFT) and uses touch or pressure to stimulate acupuncture points on the body. The free treatment groups will be held at a local therapy centre (Robina QLD). This study will be offered as a 4 week treatment group (pre and post self report questionnaires will be issued) and with 6- and 12-month followup. Subjects will attend once per week for 2 hours.
Intervention code [1] 2836 0
Treatment: Other
Comparator / control treatment
waitlist - same duration as the active treatment (4 weeks) and then subjects will be offered the same treatment as the intervention group
Control group
Active

Outcomes
Primary outcome [1] 4139 0
reduction in food cravings - this will be measured through several self report questionniares (eg Food Craving Inventory + daily diary of cravings)
Timepoint [1] 4139 0
4 week treatment and then 6 month followup and 12 month followup
Secondary outcome [1] 6979 0
weight loss
Timepoint [1] 6979 0
12 month followup

Eligibility
Key inclusion criteria
(l) over 18 years old and under 60 years and not suffering any severe psychological impairment, (2) not currently receiving treatment (psychological or medical) for their food cravings, (3) agree to be contacted for follow-up testing. Women and men will be included,
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
people who are pregnant, active diagnoses of Axis I and II conditions (DSM IV) and subjects taking ‘heavy’ psychotropic which can suppress feelings, cravings and sensitivity will be excluded. Known sufferers of diabetes (Type I and II) and hypoglycemia will be excluded due to any physiological aetiology (effects related) to food cravings

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3344 0
Charities/Societies/Foundations
Name [1] 3344 0
Association of Comprehensive Energy Psychology
Country [1] 3344 0
United States of America
Primary sponsor type
University
Name
Griffith University Logan
Address
School of Medicine
University Dr,
Meadowbrook QLD
Country
Australia
Secondary sponsor category [1] 2989 0
None
Name [1] 2989 0
Address [1] 2989 0
Country [1] 2989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5369 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 5369 0
Ethics committee country [1] 5369 0
Date submitted for ethics approval [1] 5369 0
Approval date [1] 5369 0
Ethics approval number [1] 5369 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28557 0
Address 28557 0
Country 28557 0
Phone 28557 0
Fax 28557 0
Email 28557 0
Contact person for public queries
Name 11714 0
Dr Peta Stapleton
Address 11714 0
School of Medicine Griffith University - Logan campus
University Dr, Meadowbrook QLD
Country 11714 0
Australia
Phone 11714 0
07 3382 1289
Fax 11714 0
Email 11714 0
[email protected]
Contact person for scientific queries
Name 2642 0
Dr Peta Stapleton
Address 2642 0
School of Medicine Griffith University - Logan campus
University Dr, Meadowbrook QLD
Country 2642 0
Australia
Phone 2642 0
07 3382 1289
Fax 2642 0
Email 2642 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.