Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001257459
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
Addressing Emotional and Psychological Attributes in Overweight Bariatric Patients with Emotional Freedom Techniques
Scientific title
Addressing Emotional and Psychological Attributes in Overweight Bariatric Patients with Emotional Freedom Techniques
Secondary ID [1] 288950 0
none known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 298315 0
Condition category
Condition code
Diet and Nutrition 298437 298437 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study being proposed will combine a local business product in a clinical trial with Dr Peta Stapleton’s comprehensive research on psychological acupuncture (‘tapping’) for food cravings and weight maintenance. The product is Portion Perfection; a balanced, low Glycemic Index, portion controlled eating plan, based on sound portion control research, over 20 years clinical experience and presented in a simple pictorial format. Portion Perfection sets include the pictorial book, a Portion Control Plate and bowl to eat from at every meal, along with the purse sized Healthy Snack Bible. It has been developed by Amanda Clark - who is an Advanced Accredited Practising Dietitian (Adv APD), and a leader within her field with 20 years experience. The book has photo images of the correct portion sizes of food to eat (easy to view) and participants are asked to replicate this at each meal they eat. The images make it easy to follow- they use the plates/bowls to arrange their food the same as the images. Recipes and places to purchase food are included in the book.
Three treatment groups are proposed for bariatric patients 1 years post surgery with a Body Mass Index still greater than 30:
1. Usual dietitian care versus
2. Dietitian Portion Perfection Bariatric kit versus
3. Dietitian + Perfect Portion Bariatric kit + Tapping

Groups 2 and 3 will be posted the kit to use the plates and bowls and food guides in their daily meals. They will be supported with an online Facebook secret group (no one else can see) where Amanda and Dr Stapleton will answer queries. Group 3 will receive an internet delivered EFT program (self paced over the 8 weeks of the trial) where they will be asked to watch videos of the EFT technique and use it for the suggested topics (eg food cravings). Dr Stapleton developed this - she is a clinical and health psychologist, EFT trainer and researcher, and has 22 years experience.

The intervention will last 8 weeks - it will involve eating from the kit plate/bowls at every meal and/or self pacing through the EFT videos if in that group. Followup will occur at 6- and 12-months.

Emotional freedom techniques (EFT), is a form of acupuncture using a tapping process with a cognitive component which has emerged as an effective technique for curbing food cravings (Stapleton, Sheldon, & Porter, 2010) and aiding weight loss (Church & Wilde, 2013). The EFT + kit group will also receive support via a private/secret Facebook group for Q&A related to the EFT trial videos. Each person will commit to 1 hour of the video treatment 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 EFT technique will be demonstrated in each video by Dr Stapleton and participants will follow along, doing it at home.
Intervention code [1] 294430 0
Treatment: Other
Comparator / control treatment
There is a usual care group who will act as a control - they will attend their usual dietitian appointments or followup care after their surgery.
Control group
Active

Outcomes
Primary outcome [1] 297928 0
change in weight using self reported height and weight for Body Mass Index to be calculated
Timepoint [1] 297928 0
pre and post intervention and 6- and 12-month followup points
Primary outcome [2] 299554 0
change in eating behavior measured with the Three Factor Eating Questionnaire
Timepoint [2] 299554 0
pre and post intervention and at 6- and 12-month followup points
Primary outcome [3] 299555 0
Change in food cravings using the Food Craving Inventory
Timepoint [3] 299555 0
pre and post the intervention and at 6- and 12-month followup points
Secondary outcome [1] 322658 0
change in psychological symptoms measured with the Patient Health Questionnaire, Rosenberg Self Esteem Scale and the brief COPE
Timepoint [1] 322658 0
At the end of the intervention and 6- and 12-months post intervention.

Eligibility
Key inclusion criteria
Adults with a body mass index over 30 (obese) and who have undergone bariatric surgery at least 12 months ago
Must live in Australia or USA only
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index from 0 to 29.9
Had bariatric surgery in the past 12 months
Lives anywhere other than Australia and the USA

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 occurred via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Parallel.Allocation concealment occurred via central randomisation by computer
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To explore the relationships among the constructs, a hierarchical multiple regression will be conducted. To compare the change in participants eating behaviours and psychological characteristics, MANOVAs or ANOVAs will be utilised with post hoc tests. A g*power analysis was used to determine the sample size required for a moderate effect size (80% power, at 0.05 significance level) and 100 per group was sufficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/01/2016
Date of last participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last data collection
Anticipated
30/06/2017
Actual
6/02/2017
Sample size
Target
400
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7793 0
United States of America
State/province [1] 7793 0

Funding & Sponsors
Funding source category [1] 293303 0
University
Name [1] 293303 0
Bond University
Country [1] 293303 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Bond University,
University Drive,
Robina, Queensland, Australia 4229
Country
Australia
Secondary sponsor category [1] 292110 0
Commercial sector/Industry
Name [1] 292110 0
Great Ideas in Nutrition
Address [1] 292110 0
Cnr Dutton Street & Marine Parade
Coolangatta QLD 4225
Country [1] 292110 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294779 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 294779 0
Bond University,
University Drive,
Robina, Queensland, Australia 4229
Ethics committee country [1] 294779 0
Australia
Date submitted for ethics approval [1] 294779 0
01/02/2016
Approval date [1] 294779 0
20/03/2016
Ethics approval number [1] 294779 0
0000015258

Summary
Brief summary
Obesity is a growing health concern with the effect of bariatric surgery on weight loss being significant (Buchwald et al., 2004). However, a considerable number of bariatric patients maintain or regress back after a period of time to an unsatisfactory weight (Brolin, 2002). It is proposed that 20-30% of bariatric patients do not successfully achieve appropriate weight loss (Sjostom et al., 2007; Heber et al., 2010). This sparks interest into how the post-surgery care process can be improved, with current post-surgery care focusing on providing dietary requirements in order to promote healing and maintain sufficient nutrients and hydration (Shannon, Gervasoni, & Williams, 2013). Bariatric surgery is effective in altering the volume of food consumed but further help is needed in order to change the types of food and dysfunctional eating habits (Shannon, Gervasoni, & Williams, 2013). The study being proposed will combine a local business product in a clinical trial with Dr Peta Stapleton’s comprehensive research on psychological acupuncture (‘tapping’) for food cravings and weight maintenance. The product is Portion Perfection; a balanced, low Glycemic Index, portion controlled eating plan, based on sound portion control research, over 20 years clinical experience and presented in a simple pictorial format. Three treatment groups are proposed for bariatric patients 1 years post surgery with a Body Mass Index still greater than 30:
1. Usual dietitian care versus
2. Dietitian Portion Perfection Bariatric kit versus
3. Dietitian + Perfect Portion Bariatric kit + Tapping
Emotional freedom techniques (EFT), is a form of acupuncture using a tapping process with a cognitive component which has emerged as an effective technique for curbing food cravings (Stapleton, Sheldon, & Porter, 2010) and aiding weight loss (Church & Wilde, 2013). The EFT + kit group will also receive support via a private/secret Facebook group for Q&A related to the EFT trial videos.
The primary purpose of the study is to determine whether using the Portion Perfection plates and bowls to eat from every day affects weight loss and psychological symptom improvement for people who have had bariatric surgery over a year ago and are still obese, and whether adding an online EFT (tapping) program further improves these outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65018 0
A/Prof Peta Stapleton
Address 65018 0
Bond University,
University Drive,
Robina, Queensland, Australia 4229
Country 65018 0
Australia
Phone 65018 0
+61 7 55952515
Fax 65018 0
Email 65018 0
[email protected]
Contact person for public queries
Name 65019 0
A/Prof Peta Stapleton
Address 65019 0
Bond University,
University Drive,
Robina, Queensland, Australia 4229
Country 65019 0
Australia
Phone 65019 0
+61755952515
Fax 65019 0
Email 65019 0
[email protected]
Contact person for scientific queries
Name 65020 0
A/Prof Peta Stapleton
Address 65020 0
Bond University,
University Drive,
Robina, Queensland, Australia 4229
Country 65020 0
Australia
Phone 65020 0
+61755952515
Fax 65020 0
Email 65020 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

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