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Trial registered on ANZCTR


Registration number
ACTRN12621001176853
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
1/09/2021
Date last updated
1/09/2021
Date data sharing statement initially provided
1/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation in Australian adults, with and without food addiction, to determine if a behavioural intervention for addictive eating influences cardio-metabolic profiles and neural reward responses.
Scientific title
An investigation to determine if differences exist in cardio-metabolic profiles and neural reward responses in Australian adults with and without food addiction, and if a behavioural intervention for addictive eating influences these outcomes in those with food addiction.
Secondary ID [1] 304704 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a sub study of ACTRN12621001079831.

Health condition
Health condition(s) or problem(s) studied:
Food addiction

322717 0
Addictive eating behaviours 322718 0
Condition category
Condition code
Diet and Nutrition 320308 320308 0 0
Obesity
Mental Health 320309 320309 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a sub-study of our parent study ACTRN12621001079831 and involves a sub-group of individuals with food addiction, who are participating in Arm 1 of the parent study intervention, and a group of individuals without food addiction, not participating in the parent study intervention, to have cardio-metabolic, genetic and neural reward objective markers measured at baseline and 3-months. This will require participants to attend two x 90 min assessment sessions, 3-months apart, as outlined below. Potential participants will complete an online eligibility screening survey and those deemed eligible will be allocated to either the intervention group (i.e. individuals with food addiction taking part in the parent study intervention) or the control group (i.e. individuals without food addiction not participating in the parent study intervention).

Assessment sessions:
Participants with (i.e. Arm 1 intervention group from ACTRN12621001079831) and without (i.e. control groups) food addiction will attend two x 90 min assessment sessions, 3-months apart. Those in the food addiction group they will attend the first fMRI session prior to session one of the interventions and the second fMRI after completing session 5. Prior to attending each morning assessment session at The Hunter Medical Research Institute (HMRI), located in New Lambton Heights NSW, participants will complete a series of standardised questionnaires online that will investigate symptoms of food addiction, dietary intake and eating related behaviours/habits, personality traits and mental health. On the morning of the session, participants will come fasted and after providing written consent will complete another set of surveys (investigating reward responsiveness, executive function and hedonic hunger) which will take approximately 20 mins to complete (NB. these surveys are in addition to the baseline and 3-month surveys mentioned above). Following this participants will: 1) have their height, weight measured by a trained assessor; 2) have a fasting blood test collected by a trained phlebotomist; and 3) undergo a functional magnetic resonance imaging (fMRI) scan, performed by a radiographer, and complete a food-related go/no-go task (viewing a series of core vs. non-core foods) while undergoing the fMRI (see details of images below). Participants will complete a food ‘liking’ scale (Hedonic Rating Scale) before, and hunger scales (Visual Analogue Scale) before and after the fMRI measurements. Following the assessment, participants will consume a standardised breakfast (cereal, toast, juice/tea/coffee) before going home. The total time commitment to the participants is 90 mins (80 mins experimental and 10 mins for breakfast). Participant will be reimbursed AUD50 at the end of each session.

To maintain fidelity of the experimental sessions, one of two researchers (both Accredited Practising Dietitians) will be present at each session to provide co-ordination, including implementing survey measures. On each occasion, an APD will record anthropometric measures, a trained phlebotomist will collect blood samples, and a radiographer will conduct the fMRI.

Protocol adherence: Visual Analogue Scale (VAS) will provide pre and post summary scores to aid in determining if the images were effective in eliciting appetite and hunger responses. Hedonic rating scales will provide an indication of ‘liking’ foods displayed in the images.

Food images used in the fMRI task: The images are derived from a standardised set of images from an international database which have previously been pilot tested and used in previous projects. The images are a collection of core food images (such as fruits, vegetables, meats, dairy foods, breads and cereals) and non-core foods (such as chocolate, burgers, chips, takeaways etc.).
Intervention code [1] 321484 0
Not applicable
Comparator / control treatment
A healthy control group will undertake the assessment sessions at baseline and 3-months, but not receive the intervention.
Control group
Active

Outcomes
Primary outcome [1] 328158 0
To test (feasibility) if the intervention for addictive overeating results in any neural brain changes assessed by structural image and resting-state fMRI

Timepoint [1] 328158 0
Baseline and 3-months post commencement of intervention
Primary outcome [2] 328397 0
To test (feasibility) if the intervention for addictive overeating results in any changes in neural brain responses to core vs. non-core foods assessed by a food specific Go/No go task-based fMRI
Timepoint [2] 328397 0
Baseline and 3-months post commencement of intervention
Primary outcome [3] 328398 0
To test (feasibility) if the intervention for addictive overeating results in changes in cardiometabolic profiles (plasma concentrations of HbA1c, glucose, total cholesterol, LDL, HDL, triglycerides, ghrelin, leptin, oxytocin, cortisol, cholecystokinin) assessed by commercial laboratory and enzyme-linked immunoassay (ELISA)
Timepoint [3] 328398 0
Baseline and 3-months post commencement of intervention
Secondary outcome [1] 397875 0
Genetic profiles with DNA in fasting blood samples assessed by ELISA
Timepoint [1] 397875 0
Baseline and 3-months post commencement of intervention
Secondary outcome [2] 397878 0
Executive function assessed by Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Timepoint [2] 397878 0
Baseline and 3-months post commencement of intervention
Secondary outcome [3] 397879 0
Two motivational systems: the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS) will be assessed by BIS/BAS Scale.
Timepoint [3] 397879 0
Baseline and 3-months post commencement of intervention
Secondary outcome [4] 397880 0
Impulsivity assessed by SHORT UPPS Impulsive Behavior Scale (UPPS-P)
Timepoint [4] 397880 0
Baseline and 3-months post commencement of intervention
Secondary outcome [5] 397881 0
Hedonic hunger assessed by Power of Food Scale (PFS)
Timepoint [5] 397881 0
Baseline and 3-months post commencement of intervention

Eligibility
Key inclusion criteria
Key inclusion criteria: Individuals with and without food addiction (assessed by the Yale Food Addiction Scale) living in the Newcastle area, NSW (Australia) who are proficient in English, with access to the internet, and able to visit the Hunter Medical Research Institute (Kookaburra Circuit, New Lambton Heights, NSW) for two assessment sessions 3-months apart. Additional inclusion criteria include BMI equal to or greater than 20 kg/m2, body mass less than 150kg (due to the table weight limit of the fMRI scanner), being right-handed, having normal or corrected-to-normal vision (i.e. wearing glasses), having no metallic or electronic implants, able to lie supine in the fMRI scanner for 1 hour and to perform computer-based tasks.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with a BMI less than 18.5 kg/m2, or those with purging behaviours (as identified by the Eating Disorder Examination Questionnaire, EDEQ, in the eligibility screen) or those with severe psychiatric illness (e.g. schizophrenia or bipolar disorder) or self-reported neurological or psychological illness/health condition.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Blood tests: The sample size is based on data from our pilot study (n=18), comparing differences in blood parameters in individuals with food addiction to those without food addiction, an a priori power analysis was conducted using PS: Power and Sample Size Calculation version 3.1.6 (https://biostat.app.vumc.org/wiki/Main/PowerSampleSize) to test the difference between two independent group means using a two-tailed test, a medium effect size (d= 0.50), and an alpha of 0.05. Results showed that a total sample of 38 participants with two equal sized groups of n=19 was required to achieve a power of 0.80.

fMRI task: These numbers are based on pilot data and budget constraints.

Both advanced computational modelling and classical statistical approaches will be used as appropriate to the types of data collected with specific hypotheses being addressed by each experiment. Data collected by online surveys will be analysed to determine baseline characteristics, and then analysed using statistical approaches to determine differences between groups over time as well as accounting for confounding factors. For blood test data, the linear mixed models approach allows for missing information over time and is currently accepted as best practice. Functional segregation of brain regions and networks will be based on resting-state and task-based functional images. Regression and multi-level modelling approaches will be used to relate these brain-activity measures with responses to surveys and task-responses (e.g. speed of response).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34628 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 309074 0
Government body
Name [1] 309074 0
National Health & Medical Research Council (NHMRC)
Address [1] 309074 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 309074 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 310019 0
None
Name [1] 310019 0
Address [1] 310019 0
Country [1] 310019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308948 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 308948 0
Research & Innovation Services
Research Integrity Unit
University Drive
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 308948 0
Australia
Date submitted for ethics approval [1] 308948 0
24/03/2021
Approval date [1] 308948 0
20/05/2021
Ethics approval number [1] 308948 0
H-2021-0100

Summary
Brief summary
Twenty percent of adults meet criteria for food addiction, with 70% reporting greater than four symptoms of food addiction. Food ‘addicted’ individuals have significantly lower diet quality, higher intakes of junk foods and higher weight status. The personality characteristic of impulsivity is a common risk factor for substance use and food addiction. There are currently no evidence-based interventions run by clinicians for food addiction. Current treatment options largely stem from online self-help groups such as Food Addicts Anonymous and Overeaters Anonymous which have 10 000+ members, demonstrating the clear need for services and evidence-based programs. Interventions targeting personality risk factors and motivational interviewing for other addictions, such as alcohol use, are effective. This project builds on an existing pilot study utilising a personality-based intervention for the targeted treatment of addictive overeating in individuals with food addiction and is a subgroup study of our parent study ‘Examining the efficacy of a personality-based intervention targeting addictive overeating in Australian adults: a randomised controlled trial’.

The current study will determine if the personality-based intervention targeting addictive overeating has an effect on cardio-metabolic profiles and neural reward responses in individuals with food addiction at 3 months follow up. Cardio-metabolic will be assessed via a fasting blood test, and neural reward responses will be assessed via a brain scan through clinical fMRI imaging. Additionally, this subgroup study will determine if individuals with food addiction are different from those without food addiction, in terms of their cardio-metabolic profiles, genetic profiles and structural brain function. It is hypothesised, individuals with food addiction will have improved cardio-metabolic profiles and altered neural reward responses at 3 months post-intervention compared to baseline, and individuals with food addiction will have different cardio-metabolic and genetic profiles (assessed via a fasting blood test), and heightened neural reward responses, compared to individuals without food addiction at baseline. If successful, this project will provide an evidence-based treatment for those individuals with food addiction and addictive overeating behaviours in the community and clinical services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112434 0
Prof Tracy Burrows
Address 112434 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country 112434 0
Australia
Phone 112434 0
+61 2 49215514
Fax 112434 0
Email 112434 0
tracy.burrows@newcastle.edu.au
Contact person for public queries
Name 112435 0
Prof Tracy Burrows
Address 112435 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country 112435 0
Australia
Phone 112435 0
+61 2 49215514
Fax 112435 0
Email 112435 0
tracy.burrows@newcastle.edu.au
Contact person for scientific queries
Name 112436 0
Prof Tracy Burrows
Address 112436 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country 112436 0
Australia
Phone 112436 0
+61 2 49215514
Fax 112436 0
Email 112436 0
tracy.burrows@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results will be analysed at the group data level, and any results from this trial that are published in scientific journals will publish group data only. Therefore individual, raw-line-by-line data will not be published for each participant.
What supporting documents are/will be available?
No other documents available
Summary results
No Results