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Trial registered on ANZCTR


Registration number
ACTRN12617000955314
Ethics application status
Approved
Date submitted
26/06/2017
Date registered
4/07/2017
Date last updated
4/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain Changes after Emotional Freedom Techniques for Food Cravings in Overweight Adults
Scientific title
Neural Changes in Overweight Adults with Food Cravings after Emotional Freedom Techniques Treatment: A Feasibility Study
Secondary ID [1] 292287 0
Nil
Universal Trial Number (UTN)
U1111-1197-8697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Cravings in overweight and obese adults 303806 0
Obesity 303807 0
Condition category
Condition code
Diet and Nutrition 303172 303172 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- brain scanning in fMRI machine at pre and post the psychological intervention (functional magnetic resonance imaging) - this took 30 minutes each time
- psychological intervention - once a week for 2 hours at the university campus (for a total of 4 week - so 8 hours) and it was face to face and in group delivery
- the brain scans were conducted by a radiology team at an imaging service; the psychological intervention was conducted by a trained counsellor in the technique with 10 years experience in group delivery

Treatment protocols and fidelity plans for the EFT intervention were formed prior to the trial commencing by the chief investigator. The intervention involved a 4 week (2 hours per week) program, delivered by trained EFT practitioners who were registered counsellors with a minimum of 10 years' experience. The participants were taught the technique in a group setting and also received a manual which covered the material and gave homework tasks. It has previously be conducted and published in clinical trials and was based on standardised protocols (See Craig & Fowlie, 1995). Acupressure points on the eyebrow, side of eye, under eye, under nose, chin, collarbone, under arm, and the top of the head were used. Treatment sessions involved direct exposure to craved foods. EFT techniques were utilised by participants focusing on a specific craving and associated emotion, rating the intensity of the craving using subjective units of distress (SUDs), initiating a set-up statement, and then completing the tapping process on the specific acupoints. The setup phrase focused on the individual’s difficulties and was expressed aloud in the group, adding a voiced statement of self-acceptance. Full instructions and safeguards are described in Flint, Lammers and Mitnick (2005). Participants were encouraged to self-administer EFT outside of treatment sessions in response to cravings.
Intervention code [1] 298459 0
Treatment: Other
Comparator / control treatment
The control group had the brain scan done but then did not receive the psychological intervention
Control group
Active

Outcomes
Primary outcome [1] 302552 0
Food cravings assessed with the Food Craving Inventory
Timepoint [1] 302552 0
Baseline, and post the 4 week intervention trial by way of measuring in the Food Craving Inventory. Will be repeated at 6-months followup.
Primary outcome [2] 302553 0
To test (feasibility) if the EFT intervention results in any neural brain changes
Timepoint [2] 302553 0
At pre and post (after the psychological treatment 4 week program), the scans were repeated to see any changes/activation. The fMRI scans were examined for intracranial structural abnormalities by the Radiologist partner in the study and interpreted for pre and post effect differences due to the EFT intervention.
Secondary outcome [1] 336365 0
Changes in power over food
Timepoint [1] 336365 0
At baseline and post the 4 week intervention. This will be repeated at 6-months followup. Measured with the Power of Food scale.
Secondary outcome [2] 336366 0
Changes in restraint ability over food
Timepoint [2] 336366 0
Baseline, and post the intervention, and also at 6-month followup. Measured with the Revised Restraint Scale.
Secondary outcome [3] 336367 0
Changes in psychological symptoms
Timepoint [3] 336367 0
Baseline, and post the intervention and also at 6-month followup. Measured with the Patient Health Questionnaire.

Eligibility
Key inclusion criteria
The inclusion criteria were: at least 18 years of age, both genders, overweight (i.e. Body Mass Index; BMI; between 25-29) or obese (BMI greater than 30), and not currently receiving treatment (psychological or medical) for their food cravings.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who were pregnant, and known sufferers of diabetes (Type I and II) and hypoglycemia which could impact cravings were excluded. Because of the fMRI aspect of the study, participants could not have any metal implants (e.g. pace maker) and completed a MRI head safety questionnaire prior to the scan.

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)
Central computer generated randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
This study was a pilot and had two objectives:
1: To ascertain the differences in brain activation (using fMRI) in response to food craving stimuli in overweight/obese adults, and compare to a control group, and
2: To investigate neural mechanisms of symptom improvements in overweight/obese adults following EFT treatment in order to conduct a larger trial.
The fMRI scans were analyses to identify brain regions activated by anticipation of food, and BOLD responses were contrasted. The questionnaires were analysed with MANOVA. A total of 10 adults were in the intervention group and 5 in the control group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/02/2017
Date of last participant enrolment
Anticipated
Actual
22/03/2017
Date of last data collection
Anticipated
Actual
19/06/2017
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 16520 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 296715 0
University
Name [1] 296715 0
Bond University
Country [1] 296715 0
Australia
Funding source category [2] 296831 0
Charities/Societies/Foundations
Name [2] 296831 0
Association of Comprehensive Energy Psychology
Country [2] 296831 0
United States of America
Primary sponsor type
University
Name
Bond University
Address
School of Psychology
Robina QLD 4229
Country
Australia
Secondary sponsor category [1] 295823 0
None
Name [1] 295823 0
Address [1] 295823 0
Country [1] 295823 0
Other collaborator category [1] 279612 0
Other
Name [1] 279612 0
Queensland Diagnostic Imaging
Address [1] 279612 0
Queensland Diagnostic Imaging, Gold Coast, Queensland, Australia 4226
Country [1] 279612 0
Australia
Other collaborator category [2] 279613 0
Commercial sector/Industry
Name [2] 279613 0
Siemens Healthcare
Address [2] 279613 0
Siemens Healthcare Pty Ltd, Healthcare Sector, 153 Campbell Street
Bowen Hills QLD 4006
Country [2] 279613 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297942 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 297942 0
Ethics committee country [1] 297942 0
Australia
Date submitted for ethics approval [1] 297942 0
31/10/2016
Approval date [1] 297942 0
21/12/2016
Ethics approval number [1] 297942 0

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

Contacts
Principal investigator
Name 75534 0
A/Prof Peta Stapleton
Address 75534 0
School of Psychology
Bond University
Robina QLD 4229
Country 75534 0
Australia
Phone 75534 0
+61 7 55952515
Fax 75534 0
Email 75534 0
pstaplet@bond.edu.au
Contact person for public queries
Name 75535 0
Peta Stapleton
Address 75535 0
School of Psychology
Bond University
Robina QLD 4229
Country 75535 0
Australia
Phone 75535 0
+61 7 55952515
Fax 75535 0
Email 75535 0
pstaplet@bond.edu.au
Contact person for scientific queries
Name 75536 0
Peta Stapleton
Address 75536 0
School of Psychology
Bond University
Robina QLD 4229
Country 75536 0
Australia
Phone 75536 0
+61 7 55952515
Fax 75536 0
Email 75536 0
pstaplet@bond.edu.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
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Documents added automatically
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