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Trial registered on ANZCTR


Registration number
ACTRN12621001079831
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
16/08/2021
Date last updated
20/03/2023
Date data sharing statement initially provided
16/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A telehealth program targeting addictive overeating for Australian adults with food addiction
Scientific title
Examining the efficacy of a telehealth intervention targeting addictive overeating in Australian adults: a randomised controlled trial.
Secondary ID [1] 304700 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12619001540101 is the pilot study of this study. This intervention will be used in a separate sample of participants to determine the effectiveness of the intervention on cardiometabolic and genetic risk markers, and neural reward responsiveness (see ACTRN12621001176853).

Health condition
Health condition(s) or problem(s) studied:
Food addiction 322708 0
Addictive eating behaviours 322709 0
Condition category
Condition code
Diet and Nutrition 320302 320302 0 0
Obesity
Mental Health 320303 320303 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a randomised controlled trial comprising three parallel arms. The primary outcome is the change in food addiction symptoms with random allocation to either 1) Active intervention arm, 2) Passive intervention arm, or 3) Control arm. Following eligibility screening, and online consent, randomisation will occur after the completion of baseline survey assessments. 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. Survey measures will also be completed at 3-month post-baseline assessment (primary time point), and the study also includes a 6-month post-baseline follow-up assessment.

Active Intervention:
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.

On completion of the five telehealth sessions, participants will be invited to join a closed Facebook group from 3-months until the 6-month outcome survey measures are conducted. Joining the Facebook group is voluntary.

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.


Passive intervention arm:
Participants will receive the intervention via self-guided approach, with access to the five-module workbook and website (as described above), but without the telehealth consults. The content of the workbook modules mirrors the content of the five telehealth sessions. Participants will be asked, on receipt of the workbook, to complete the workbook within a 3-month period. Following the 3-month self-guided learning period, participants will be invited to join a closed Facebook group from 3-months until the 6-month outcome survey measures are conducted. Joining the Facebook group is voluntary. The proportion of the workbook completed by participants in the passive intervention arm will not be monitored. As a measure of adherence, engagement with the website and the Facebook group will be monitored. For example, the number of website visits, length of website visits, website visitor path, and website top pages; number of Facebook likes and comments, and number of Facebook visits will be measured.
Intervention code [1] 321080 0
Lifestyle
Intervention code [2] 321081 0
Behaviour
Intervention code [3] 321199 0
Treatment: Other
Comparator / control treatment
Control arm:
Participants will receive personalised dietary feedback on baseline surveys, provided by an automated report, generated from the Australian Eating Survey. This is consistent with standard dietary care if the participant was to see a dietitian.
The comparator groups were chosen to provide a passive delivery option of the intervention which would be consistent with a self-guided Cognitive Behaviour Therapy approach, and a control group consistent with a standard version of dietetic care. Participants in the control group will be offered access to the participant workbook and study website after the completion of the 6-month assessment.
Control group
Active

Outcomes
Primary outcome [1] 328153 0
Food addiction symptoms and severity assessed via the Yale Food Addiction Scale (YFAS 2.0)
Timepoint [1] 328153 0
Baseline (pre-intervention), 3-months (primary timepoint) and 6-months after intervention commencement
Secondary outcome [1] 397862 0
Changes in dietary intake and quality will be assessed using the Australian Eating Survey (AES). The will include: (1) % Daily energy intake from core foods and non-core foods; (2) average daily energy intake, % Daily energy intake contributed by macronutrients, micronutrient intakes; and (3) overall diet quality (Australian Recommended Food Score provided by the AES).
Timepoint [1] 397862 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [2] 397863 0
Anxiety assessed via the Generalised Anxiety Disorder scale (GAD-7)
Timepoint [2] 397863 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [3] 397864 0
Depressive symptoms assessed via the Patient Health Questionnaire-8 (PQH-8)
Timepoint [3] 397864 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [4] 397865 0
Perceived stress assessed via the Perceived Stress Scale (PSS-4)
Timepoint [4] 397865 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [5] 397866 0
Additional other outcome (not secondary outcome): Health-related quality of life assessed via the EQ-5D-5L
Timepoint [5] 397866 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [6] 397867 0
Additional other outcome (not secondary outcome): Health care utilisation assessed via a study-specific version of the Consumer Services Receipt Inventory (CSRI)
Timepoint [6] 397867 0
Baseline (pre-intervention), 3-months and 6-months post commencement of intervention
Secondary outcome [7] 398518 0
Additional other outcome (not secondary outcome): Engagement with the study website assessed via number of website visits, length of website visits, website visitor path, and website top pages. These will be assessed as a composite secondary outcome using website analytics.
Timepoint [7] 398518 0
3-months and 6-months post commencement of intervention
Secondary outcome [8] 398519 0
Additional other outcome (not secondary outcome): Engagement with the Facebook group assessed via number of Facebook visits, Facebook likes, and number of engagements on Facebook. These will be assessed as a composite secondary outcome and assessed as frequency of of page views and likes
Timepoint [8] 398519 0
6-months post commencement of intervention

Eligibility
Key inclusion criteria
Residents of Australia, endorsing 3 or more food addiction symptoms (as defined by the Yale Food Addiction Scale), BMI equal to or greater than 18.5 kg/m2, proficient in English, with access to the internet
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with purging behaviours (as identified by the Eating Disorder Examination Questionnaire, EDEQ, in the eligibility screen) or individuals with confounding health conditions such as severe psychiatric illness (e.g. schizophrenia or bipolar disorder). Females who are pregnant or lactating.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation (groups stratified for sex and depression/anxiety as determined by eligibility surveys), followed by block randomisation using a permuted block design with a computer random number generator. This changes were made after all 175 participants were enrolled. Please note, the randomisation procedure has not changed.
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
Efficacy
Statistical methods / analysis
The sample size was calculated to determine a difference in YFAS scores. For a 2-unit difference between the means of change scores (SD = 2.2) for the passive intervention group or control group and active intervention group. For a standardised effect size of d=0.91, a sample size of 25 in each group would detect this with power 0.80 with type 1 error rate set at 0.025 to account for multiple testing for effect size being estimated for 2 different control groups. That is a total sample size of 75 participants, but allowing for 30% dropout this increases to 36 per group and total sample size of 108. Increasing power to 0.90 would require a total of 32 subjects per group and a total sample size of 94. Allowing for 30% dropout requires 46 per group and total sample size of 138. Therefore, 150 is the final sample size to remain conservative.

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. The linear mixed models approach allows for missing information over time and is currently accepted as best practice. When randomised, the groups will be stratified for sex and depression/anxiety scores as determined by surveys. Additionally, analyses of the study website will include visitor type, visitor length, visitor path and top pages to determine differences in usage and engagement between study groups as well as deidentified Facebook metrics such as likes and number of engagements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2021
Actual
23/08/2021
Date of last participant enrolment
Anticipated
15/07/2022
Actual
7/04/2022
Date of last data collection
Anticipated
15/01/2023
Actual
14/12/2022
Sample size
Target
150
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 34616 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 309067 0
Government body
Name [1] 309067 0
National Health & Medical Research Council (NHMRC)
Country [1] 309067 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 310014 0
None
Name [1] 310014 0
Address [1] 310014 0
Country [1] 310014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308944 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 308944 0
Ethics committee country [1] 308944 0
Australia
Date submitted for ethics approval [1] 308944 0
24/03/2021
Approval date [1] 308944 0
20/05/2021
Ethics approval number [1] 308944 0
H-2021-0100

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112418 0
Prof Tracy Burrows
Address 112418 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Country 112418 0
Australia
Phone 112418 0
+61 2 49215514
Fax 112418 0
Email 112418 0
tracy.burrows@newcastle.edu.au
Contact person for public queries
Name 112419 0
Tracy Burrows
Address 112419 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Country 112419 0
Australia
Phone 112419 0
+61 2 49215514
Fax 112419 0
Email 112419 0
tracy.burrows@newcastle.edu.au
Contact person for scientific queries
Name 112420 0
Tracy Burrows
Address 112420 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Country 112420 0
Australia
Phone 112420 0
+61 2 49215514
Fax 112420 0
Email 112420 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
EmbaseExamining the efficacy of a telehealth intervention targeting addictive eating in Australian adults (the TRACE Programme): A randomised controlled trial protocol.2023https://dx.doi.org/10.1136/bmjopen-2022-064151
EmbaseA three-arm randomised controlled trial of a telehealth intervention targeting improvement in addictive eating for Australian adults (the TRACE program).2024https://dx.doi.org/10.1016/j.appet.2024.107211
N.B. These documents automatically identified may not have been verified by the study sponsor.