Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000410156
Ethics application status
Approved
Date submitted
8/03/2019
Date registered
13/03/2019
Date last updated
11/03/2020
Date data sharing statement initially provided
13/03/2019
Date results information initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation in adults to determine if physiological responses to visual food cues are associated with addictive eating behaviour
Scientific title
Physiological measures as novel biomarkers of addictive eating behaviours: a pilot study in adults to determine if physiological responses to visual food cues are associated with addictive eating behaviour
Secondary ID [1] 297571 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 311822 0
Food addiction 311825 0
Condition category
Condition code
Diet and Nutrition 310426 310426 0 0
Obesity
Mental Health 310427 310427 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study has a within subject study design. After determining eligibility, via an online screening, participants will complete a series of standardised questionnaires (Yale Food Addiction Scale, Addiction-like Eating Behaviour Scale, The Self-Report Habit Index, The Power of Food Scale, Perceived Stress Scale, Generalized Anxiety Disorder scale, The Patient Health Questionnaire, The Substance Use Risk Profile Scale) online prior to attending a one-off experimental session at the University of Newcastle. On arrival participants will have their height and weight measured by a trained assessor. Participants will complete an IT-mediated task, integrated with physiological measures (heart rate variability, electrodermal activity and pupillary responses) under controlled conditions. This task will involve viewing two x 5min food image paradigms (healthy vs. hyperpalatable foods) on a computer monitor with a 2min wash-out period of neutral images (non-food images) shown in between. Participants will be randomly allocated by block design to group 1 or group 2. Group 1 will view healthy food images first, and hyperpalatable food images second. Group 2 will view hyperpalatable food images first, and healthy food images second. Participants will complete a self-report measure of current hunger (Visual Analogue Scale) before and after viewing the images, and emotional response to images will also be recorded via paper based survey at the end of the session. The session will take approximately 45min to complete and will be administered by an Accredited Practising Dietitian.

Image paradigms: food image stimuli to be used in this task has previously been rated in a pilot study (n=10 adults, independent of those involved in the present study) to ensure foods are representative of each of the two categories, and food images are readily identifiable i.e. recognisable and familiar, and shown in an appetising manner for Australian adults. Images are from a licensed database and non-copyrighted sources. Healthy food pictures are based on the five core food groups, and hyperpalatable food pictures based on foods categorised as discretionary choices, outlined in The Australian Guide to Healthy Eating.

Intervention adherence: Visual Analogue Scale (VAS) will provide pre and post summary scores to aid in determining if the image paradigms were effective in eliciting appetite and hunger responses. An on/off task will be conducted during the image paradigms to identify non-responders i.e. images will be auto advanced with the exception of 2 timepoints. At 100s and 200s participants will be asked to manually ‘click next’ on the computer screen to enable viewing of the next image.

To maintain fidelity each experimental session will be conducted in the same laboratory room and one researcher (Accredited Practising Dietitian) will conduct all the sessions, including anthropometric measurements.
Intervention code [1] 313802 0
Other interventions
Comparator / control treatment
Participants act as their own control (crossover study)
Control group
Active

Outcomes
Primary outcome [1] 319292 0
Heart rate variability measured using an electrocardiography (ECG) measurement device (“PowerLab 8/35 Bio Amp”, by AD Instruments)
Timepoint [1] 319292 0
Baseline and continuously throughout the 12 minute session (5 min healthy food images, 2 min neutral images, and 5 min hyperpalatable food images)
Primary outcome [2] 319383 0
Electrodermal activity on the palm of the hand measured using a Galvanic Skin Response (GSR) recording device (“PowerLab 8/35 Bio Amp”, by AD Instruments)
Timepoint [2] 319383 0
Baseline and continuously throughout the 12 minute session (5 min healthy food images, 2 min neutral images, and 5 min hyperpalatable food images)
Primary outcome [3] 319384 0
Pupillary responses (composite of pupil fixations and saccades) will be recorded using an eye tracking device (Tobii Pro X3-120).
Timepoint [3] 319384 0
Baseline and continuously throughout the 12 minute session (5 min healthy food images, 2 min neutral images, and 5 min hyperpalatable food images)
Secondary outcome [1] 367992 0
Subjective hunger measured by Visual Analogue Scale
Timepoint [1] 367992 0
Baseline and on session completion (i.e. after viewing of image paradigms)

Eligibility
Key inclusion criteria
Individuals proficient in English with access to the internet and able to visit the University of Newcastle for a one-off visit will be recruited via advertisements on social media platforms (e.g. Facebook, twitter), and advertisements posted on community noticeboards on University of Newcastle campuses.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with epilepsy, a known heart condition, taking beta blockers, digoxin, or wearing a pacemaker; allergy to adhesive electrode patches or electrode gel used for ECG and GSR procedures. Individuals required to wear glasses with bifocal/varifocal lenses or have any of the following eye conditions: cataracts, prosthetic or bionic eye, amblyopia (commonly referred to as lazy eye). Individuals following a vegetarian diet or specialised diet that will affect their ability to view the food images (e.g. meat and dairy foods).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 50 was determined based on sample size calculation to detect moderate effect sizes (i.e. d 0.4 to 0.6) on the primary outcome variable of addictive eating behaviour and heart rate variability, and takes into consideration pilot study status of the research. Data will initially be analysed descriptively and presented as mean ± SD or median and IQR, as appropriate. T-tests and ANOVA, or non-parametric tests if appropriate, will be conducted to examine within subject and between groups differences in physiological responses. If possible, linear mixed models will be employed as there will be multiple data-points per participant. Baseline measures will be used as covariates. BMI and other potentially confounding variables, such as age and sex, may be added as covariates if they are significantly correlated with the outcome measures. This statistical analysis will help in determining whether there is a significant main effect for each independent variable by testing for between subject effects. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/03/2019
Actual
18/03/2019
Date of last participant enrolment
Anticipated
Actual
1/10/2019
Date of last data collection
Anticipated
Actual
2/10/2019
Sample size
Target
50
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25849 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 302120 0
University
Name [1] 302120 0
University of Newcastle
Country [1] 302120 0
Australia
Primary sponsor type
Individual
Name
Assoc/Prof Tracy Burrows
Address
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 301955 0
None
Name [1] 301955 0
Address [1] 301955 0
Country [1] 301955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302801 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 302801 0
Research Integrity Unit
Research & Innovation Services
NIER Precinct
Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 302801 0
Australia
Date submitted for ethics approval [1] 302801 0
07/12/2017
Approval date [1] 302801 0
06/02/2018
Ethics approval number [1] 302801 0
H-2017-0418

Summary
Brief summary
This project is a pilot study in adults to investigate physiological measures as novel biomarkers of food addiction. Impaired physiological responses (e.g. heart rate variability, pupillary responses) have been found in other forms of dysfunctional eating patterns (e.g. binge eating, bulimia nervosa, obesity) and are linked to abnormal functioning of neural circulatory. This project will recruit males and females >18yrs to determine if physiological measures in response to visual food stimuli are associated with food addiction.

It is hypothesised that adults presenting with moderate-severe food addiction symptom scores will have lower heart rate variability, increased sweat responses and greater attentional biases toward hyperpalatable foods (i.e. junk foods) compared to adults with low symptom scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91446 0
A/Prof Tracy Burrows
Address 91446 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 91446 0
Australia
Phone 91446 0
+61 2 49215514
Fax 91446 0
Email 91446 0
[email protected]
Contact person for public queries
Name 91447 0
A/Prof Tracy Burrows
Address 91447 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 91447 0
Australia
Phone 91447 0
+61 2 49215514
Fax 91447 0
Email 91447 0
[email protected]
Contact person for scientific queries
Name 91448 0
A/Prof Tracy Burrows
Address 91448 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 91448 0
Australia
Phone 91448 0
+61 2 49215514
Fax 91448 0
Email 91448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1555Study protocol    377097-(Uploaded-08-03-2019-11-57-22)-Study-related document.pdf
1556Ethical approval    377097-(Uploaded-08-03-2019-11-49-09)-Study-related document.pdf



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.