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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
4/10/2024
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
Please see ACTRN12621001079831 for a description the intervention.

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
Interventional
Description of intervention(s) / exposure
This project is a non-randomised controlled trial comprising two arms: 1) Intervention arm, and 2) Control arm. Following eligibility screening, online consent, and completion of baseline survey assessments, participants with food addiction will be allocated to the intervention arm, and participants without food addiction will be allocated to the control arm. Participants allocated to the intervention arm will take part in a 3-month telehealth intervention for addictive eating (see Intervention description below), and participants in the control arm will follow their usual eating patterns for 3-months.

Survey measures will be completed by all participants at baseline and 3-month post-baseline assessment. Survey measures will investigate symptoms of food addiction, dietary intake and eating related behaviours/habits, traits associated with personality and risk of addictive behaviour, mental health, quality of life and health care utilisation.

All participants will 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.

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.).

Telehealth intervention:
The telehealth intervention, that participants in the intervention arm will complete, is identical to that of ACTRN12621001079831. The active intervention arm will target change in addictive eating behaviours using a multicomponent clinician led approach (telehealth sessions, program workbook and program website). Participants will receive five standardised one-on-one telehealth/phone sessions, with a Accredited Practising Dietitian, over a 3-month period (i.e. weeks 1, 2, 4, 8 and 12). Sessions will range from 15-45 mins. Telehealth sessions will be provided via the VSee platform (www.vsee.com). The active intervention uses, personalised feedback, skill-building exercises and goal setting to help individuals reduce their symptoms of addictive eating, improve their dietary intake and their relationship with food. The intervention is personalised based on an individual’s dominant trait/s associated with personality and risk of addictive behaviours (measured via The Substance Use Risk Profile Scale at baseline) and addresses a range of factors that influence one’s behaviour, both internal and external.

Each session will be facilitated by an Accredited Practising Dietitian with training in behaviour change. During Session 1, participants will be provided with feedback on their baseline scores of addictive eating and major trait/s associated with personality and risk of addictive behaviour. The participant’s main concerns with their food intake will be determined, and how their specific trait/s associated with personality and risk of addictive behaviour may relate to their food intake and addictive eating will be discussed. Participants will be introduced to various coping strategies, relevant to their major trait/s associated with personality and risk of addictive behaviour, that can be implemented to assist in improving their eating behaviours. This will include the ‘Distraction List’. During Session 2, participant’s will be provided with feedback on their dietary intake and diet quality; and participant’s will develop three nutrition goals using a ‘SMARTER Goal Checklist’. Participant’s progress with the coping strategies, introduced in session 1, will be reviewed and enablers/barriers to making changes to eating habits will be discussed. During Session 3, the 'Triggers for Overeating' task that was completed as home work will be discussed, and strategies created to overcome these triggers. Participant’s will be introduced to the ‘Mood Monitor’ worksheet to track emotional triggers for eating. During Session 4, the importance of sleep, physical activity and responsible intake of alcohol/ caffeine for emotional health will be discussed. This information, and information provided in sessions 1 to 3, will be consolidated into an overall plan for the participant to achieve their to achieve SMARTER goals.
Session 5 will consist of a brief check-in to assess progress and problem solve any concerns. Participants will be encouraged to continue with their goals and strategies.

Participants will have access to a study specific website and a participant workbook, both built for the study to support the materials discussed in the intervention sessions.
The website includes the following pages: 1) Home/Landing page: brief information about the program and login; 2) Dashboard: navigation page to access each of the program’s module pages; 3) Module pages: each of the five modules within the intervention has a separate page on the website. This includes the content for that module, complementary to that included within the corresponding telehealth session and section of the workbook; and 4) About us: brief information about the research/clinician team behind the program, including contact information (email).
The workbook consists of five modules: 1) Personality; 2) Food; 3) Skills; 4) Confidence; and 5) Moving forward. The clinician manual that will be used by the dietitian during each of the telehealth sessions has been converted into a workbook so that the content of the five modules mirrors that of the telehealth sessions. The workbook also contains activities/worksheets, discussed during the telehealth sessions, for the participants to complete. The amount of time spent completing activities in the workbook each week, between telehealth sessions, will take approximately 30 - 60 minutes. However, this may vary from person to person, and participants are advised to work through the workbook at a pace that is right for them.

Dietitians administering the intervention will trained by the principal investigator prior to study implementation. A detailed clinician manual will be used by the dietitian for all sessions to ensure treatment fidelity. Dietitians will also be required to follow each session as outlined in the manual. Standardised records of implementation of each session will be kept by the dietitian. Regular supervisory meetings will be conducted with the dietitians and led by the principal investigator. Participant adherence to the intervention will be assessed by a session attendance checklist completed by a member of the research team. Dietitians administering the telehealth sessions will monitor completion of homework tasks and workbook activities at the start of telehealth sessions 2 to 5. Assistance will be provided by the dietitian at this time if participants experienced any difficulties completing the homework tasks/activities. Additionally, to assist with adherence, on completion of each telehealth session the dietitian will email a personalised ‘Addictive Eating Action Plan’, completed on a standardised template, to the participant.
Intervention code [1] 321484 0
Diagnosis / Prognosis
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
Sex
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 of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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
Completed
Date of first participant enrolment
Anticipated
30/09/2021
Actual
16/02/2022
Date of last participant enrolment
Anticipated
14/12/2023
Actual
28/03/2024
Date of last data collection
Anticipated
30/03/2024
Actual
15/05/2024
Sample size
Target
40
Accrual to date
Final
20
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)
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
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
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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDesigning an online intervention for adults with addictive eating: a qualitative integrated knowledge translation approach.2022https://dx.doi.org/10.1136/bmjopen-2021-060196
N.B. These documents automatically identified may not have been verified by the study sponsor.