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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]

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

Addictive eating behaviours

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

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]

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]

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]