Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001256460
Ethics application status
Approved
Date submitted
6/04/2016
Date registered
8/09/2016
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does online delivery of Emotional Freedom Techniques for Food Cravings work as well as attending treatment in person?
Scientific title
Online Treatment of Food Cravings in Overweight and Obese Adults using Emotional Freedom Techniques
Secondary ID [1] 288948 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 298312 0
food cravings 298313 0
Condition category
Condition code
Diet and Nutrition 298435 298435 0 0
Obesity
Mental Health 299866 299866 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a weekly video email of the treatment program (Dr Stapleton who is a clinical and health psychologist with 22 years experience) which will teach the treatment process (which is the EFT technique) via pre-recorded video for that week (it is self paced for 8 weeks). Weekly handouts and email support from the lead researchers will also be supplied. Therefore the program will be: an online education intervention which is self-guided, but with human-support. Video software will monitor how often participants watch the videos, and the pace at which they move through the program. A few brief questions will be asked as multiple choice questions at the end of each video, taken directly from that video, before a person can progress to the next one. This is to ensure skipping ahead cannot occur.

Each person will commit to 1 hour of the video intervention (which is the EFT being demonstrated) per week (to watch it) and a further 20-30 minutes at the beginning, end and followup points to complete the questionnaires.

The topics which will be covered in the 8-weeks include: Psycho-education about the treatment and how it works; The nature of food cravings and how they are cognitively formed; Feelings and Food; Cognitive restructuring; Stress and relaxation training; Goal setting; Good nutrition; and Relapse prevention.

The technique is EFT - or Emotional Freedom Techniques. EFT is a brief novel intervention combining elements of exposure and cognitive therapy, and somatic stimulation. It is often referred to as ‘psychological acupuncture’ and uses a two finger tapping process with a cognitive statement.
Intervention code [1] 294429 0
Treatment: Other
Intervention code [2] 295666 0
Lifestyle
Comparator / control treatment
Wait list - group that will complete surveys up front, but then wait the length of treatment (8 weeks), before undergoing the treatment themselves.
Control group
Active

Outcomes
Primary outcome [1] 297927 0
Outcome - change in food cravings using the Food Craving Questionnaire
Timepoint [1] 297927 0
pre and post treatment, and 6 and 12 months followup
Primary outcome [2] 299552 0
change in restraint ability using the Revised Restraint Scale;
Timepoint [2] 299552 0
pre and post treatment and at 6- and 12-months followup
Primary outcome [3] 299553 0
change in one's willpower over food using the Power of Food scale
Timepoint [3] 299553 0
pre and post treatment and at 6- and 12-months followup
Secondary outcome [1] 326891 0
changes in weight by collecting weight measurements.
Timepoint [1] 326891 0
At baseline, completion of program and 6- and 12-month followup periods
Secondary outcome [2] 327496 0
changes in psychological symptoms using the Patient Health Questionnaire;
Timepoint [2] 327496 0
pre and post treatment and at 6- and 12-months followup

Eligibility
Key inclusion criteria
18 years and over
Body Mass Index greater than 25 (overweight)
Access to internet, email
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index in healthy range, or underweight

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)
Allocation concealment will occur by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Allocation concealment will occur by central randomisation by computer
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A repeated measures ANOVA will be used to investigate the changes in mean scores over the 4 time points (pre, post, 6 and 12 month followup) in the online treatment group (within measures). A g*power analysis will be conducted to determine an appropriate sample size to achieve a moderate effect size (80% power at 0.05 significance level) - A g*power analysis suggests 122 participants in total for this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last data collection
Anticipated
30/06/2017
Actual
3/04/2017
Sample size
Target
120
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7790 0
New Zealand
State/province [1] 7790 0
Country [2] 7791 0
United States of America
State/province [2] 7791 0
Country [3] 7792 0
United Kingdom
State/province [3] 7792 0

Funding & Sponsors
Funding source category [1] 293301 0
University
Name [1] 293301 0
Bond University
Country [1] 293301 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive, Robina, Queensland, Australia 4229
Country
Australia
Secondary sponsor category [1] 292109 0
None
Name [1] 292109 0
Address [1] 292109 0
Country [1] 292109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294776 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 294776 0
Ethics committee country [1] 294776 0
Australia
Date submitted for ethics approval [1] 294776 0
01/04/2015
Approval date [1] 294776 0
22/05/2015
Ethics approval number [1] 294776 0
0000015270

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

Contacts
Principal investigator
Name 65014 0
A/Prof Peta Stapleton
Address 65014 0
School of Psychology
Bond University
University Dr Robina QLD 4229
Country 65014 0
Australia
Phone 65014 0
+61 7 55952515
Fax 65014 0
Email 65014 0
[email protected]
Contact person for public queries
Name 65015 0
Peta Stapleton
Address 65015 0
School of Psychology
Bond University
University Dr Robina QLD 4229
Country 65015 0
Australia
Phone 65015 0
+61755952515
Fax 65015 0
Email 65015 0
[email protected]
Contact person for scientific queries
Name 65016 0
Peta Stapleton
Address 65016 0
School of Psychology
Bond University
University Dr Robina QLD 4229
Country 65016 0
Australia
Phone 65016 0
+61755952515
Fax 65016 0
Email 65016 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.