Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001079639
Ethics application status
Approved
Date submitted
19/09/2023
Date registered
10/10/2023
Date last updated
10/10/2023
Date data sharing statement initially provided
10/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an addictive eating intervention on eating behaviours and overall relationship with food and diet quality in young adults
Scientific title
Evaluating the feasibility and preliminary efficacy of a cardiovascular disease prevention intervention targeting addictive and compulsive overeating among young adults with symptoms of mental ill health
Secondary ID [1] 308632 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Addiction 328535 0
Addictive eating behaviours 328536 0
Cardiovascular disease 328537 0
Condition category
Condition code
Diet and Nutrition 325553 325553 0 0
Obesity
Mental Health 325554 325554 0 0
Addiction
Cardiovascular 325555 325555 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This feasibility study is a randomised controlled trial comprising two parallel arms. The primary outcome is the change in addictive eating symptoms, and cardiovascular disease (CVD) biomarkers, with random allocation to either 1) Intervention arm, or 2) Control arm. Following eligibility screening, and online consent, randomisation will occur after completion of baseline survey assessments and a CVD biomarker assessment. Survey measures will investigate symptoms of addictive eating, dietary intake and eating related behaviours/habits, personality traits, physical activity levels, sleep hygiene behaviours and mental health symptoms. CVD biomarkers assessed, via fasting blood test, include total cholesterol, HDL, LDL, triglycerides, HbA1c and glucose. Survey measures and CVD Biomarker Assessment will also be completed at 3-month post-baseline assessment.

Rationale for this study includes determining the effectiveness of the intervention on addictive eating behaviours and on CVD biomarkers.

Intervention:
The intervention arm will target change in addictive eating behaviours and physical activity levels using a multicomponent clinician led approach (telehealth sessions, program workbook, program website and scheduled text messaging). 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. The intervention is personalised based on an individual’s dominant personality trait/s (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. Participants will not be required to follow a specific diet over the intervention period.

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 personality trait/s. The participant’s main concerns with their food intake will be determined, and how their specific personality traits may relate to their food intake and addictive eating will be discussed. Participants will be introduced to various coping strategies, relevant to their major personality trait/s, 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 physical activity levels; and participant’s will develop three nutrition goals and one physical activity goal (4 goals in total) 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. Participants 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, designed specifically for this study, 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, designed specifically for this study, 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.

Process Evaluation:
In addition to the 3-month follow-up survey, participants including those who have discontinued the study before the 3-month follow-up (i.e., discontinued intervention sessions and/or not completed the 3-month survey) will be invited to complete a 10 min phone interview to evaluate the acceptability of the intervention. Participants who have formally withdrawn from the study (verbal or written withdrawal) will not be contacted.

CVD Biomarker Assessment:
The ‘CVD Biomarker Assessment’ consists of two visits to a NSW Health Pathology Collection Centre in NSW, where participants will have a fasting blood test collected by a trained phlebotomist. Participants will be provided with a list of NSW Health Pathology Collection Centre locations across NSW from which they can choose a centre that is convenient for them to visit. At each visit the participant’s total cholesterol, HDL, LDL, triglycerides, HbA1c and glucose levels will be measured. The visits will occur 1) at baseline prior to the intervention commencement, and 2) at 3-month post study commencement. As participants are required to fast overnight prior to their blood test (i.e., no food consumed after 10pm the evening before) they will be asked to attend a collection centre in the morning between 8am and 10am on a day that is convenient for them. Following randomisation, participants will be emailed a NSW Health Pathology referral form (prepared by the pathology company) which is to be taken with them on the morning of their visit to the collection centre.
Intervention code [1] 325090 0
Lifestyle
Intervention code [2] 325091 0
Behaviour
Intervention code [3] 327102 0
Treatment: Other
Comparator / control treatment
Participants in the control group will follow their usual dietary regime for a period of 3 months.

At 3-months post study commencement, the control group will receive a passive version of the intervention, which includes a self-guided workbook. Following completion of the 3-month survey assessments and CVD biomarker assessment, participants will be given access to the study website for a period of 3-months and the five-module workbook (emailed to participants, in addition to a copy housed on the website), but without the telehealth consults. The content of the workbook modules mirrors the content of the five telehealth sessions.

The control was chosen to provide a passive delivery option of the intervention which would be consistent with a self-guided Cognitive Behaviour Therapy approach.
Control group
Active

Outcomes
Primary outcome [1] 333395 0
To assess if the intervention for addictive eating results in changes in addictive eating symptom scores assessed via the Yale Food Addiction Scale (YFAS 2.0)
Timepoint [1] 333395 0
Baseline and 3-months post commencement of intervention
Primary outcome [2] 333396 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of HbA1c assessed by commercial laboratory.
Timepoint [2] 333396 0
Baseline and 3-months post commencement of intervention
Primary outcome [3] 336195 0
To assess if the intervention for addictive eating results in changes in addictive eating severity assessed via the Yale Food Addiction Scale (YFAS 2.0)
Timepoint [3] 336195 0
Baseline and 3-months post commencement of intervention
Secondary outcome [1] 416897 0
Change in % Daily energy intake from core foods assessed via the Australian Eating Survey (AES)
Timepoint [1] 416897 0
Baseline and 3-months post commencement of intervention
Secondary outcome [2] 416898 0
Change in % Daily energy intake from non-core foods assessed via the Australian Eating Survey (AES)
Timepoint [2] 416898 0
Baseline and 3-months post commencement of intervention
Secondary outcome [3] 416899 0
Change in physical activity levels assessed via Active Australia Survey (AAS)
Timepoint [3] 416899 0
Baseline and 3-months post commencement of intervention
Secondary outcome [4] 416900 0
Change in sleep hygiene behaviours assessed via the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [4] 416900 0
Baseline and 3-months post commencement of intervention
Secondary outcome [5] 416901 0
Change in anxiety assessed via the Generalised Anxiety Disorder scale (GAD-7)
Timepoint [5] 416901 0
Baseline and 3-months post commencement of intervention
Secondary outcome [6] 416902 0
Change in depressive symptoms assessed via the Patient Health Questionnaire-8 (PQH-8)
Timepoint [6] 416902 0
Baseline and 3-months post commencement of intervention
Secondary outcome [7] 416903 0
Change in perceived stress assessed via the Perceived Stress Scale (PSS-4)
Timepoint [7] 416903 0
Baseline and 3-months post commencement of intervention
Secondary outcome [8] 427290 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of glucose assessed by commercial laboratory (primary outcome)
Timepoint [8] 427290 0
Baseline and 3-months post commencement of intervention
Secondary outcome [9] 427291 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of total cholesterol assessed by commercial laboratory (primary outcome).
Timepoint [9] 427291 0
Baseline and 3-months post commencement of intervention
Secondary outcome [10] 427712 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of HDL cholesterol assessed by commercial laboratory (primary outcome).
Timepoint [10] 427712 0
Baseline and 3-months post commencement of intervention
Secondary outcome [11] 427713 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of LDL cholesterol assessed by commercial laboratory (primary outcome).
Timepoint [11] 427713 0
Baseline and 3-months post commencement of intervention
Secondary outcome [12] 427714 0
To assess if the intervention for addictive eating results in changes in plasma concentrations of triglycerides assessed by commercial laboratory (primary outcome).
Timepoint [12] 427714 0
Baseline and 3-months post commencement of intervention
Secondary outcome [13] 427715 0
To assess the feasibility and acceptability of the intervention for young adults, a qualitive interview (using a study specific interview script) will be conducted to obtain participant's views and experiences of the intervention
Timepoint [13] 427715 0
On study completion (i.e. 3-months post commencement of intervention)

Eligibility
Key inclusion criteria
Young adults (aged 18 - 35 years) living in NSW (Australia) endorsing 3 or more addictive eating symptoms (as defined by the Yale Food Addiction Scale) who are able to visit a NSW Health Pathology blood collection centre to have two fasting blood tests 3-months apart. Additional inclusion criteria include individuals with BMI 18.5 kg/m2 or over, proficient in English, and with access to the internet.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be ineligible to participate if they have a BMI less than 18.5 kg/m2, have self-report purging behaviours (as identified by the Eating Disorder Examination Questionnaire, EDEQ-Short form, in the eligibility screen), have a history of a medically diagnosed eating disorder (e.g., Binge Eating Disorder, Bulimia Nervosa or Anorexia Nervosa), have a diagnosed severe psychiatric disorder e.g., Bipolar Disorder, psychosis, have medically diagnosed cardiovascular disease, including high blood pressure, high cholesterol or triglycerides.

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size based on intention to treat was determined to detect a difference between groups with 80% power. A total sample of 60 (30 per intervention group and 30 per control group) would be required allowing for a 20% attrition rate at end follow up.

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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2023
Actual
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
30/05/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39172 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 312870 0
Charities/Societies/Foundations
Name [1] 312870 0
National Heart Foundation of Australia
Country [1] 312870 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 314534 0
None
Name [1] 314534 0
None
Address [1] 314534 0
Country [1] 314534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312148 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 312148 0
Research & Innovation ServicesResearch Integrity UnitThe University of NewcastleCallaghan NSW 2308
Ethics committee country [1] 312148 0
Australia
Date submitted for ethics approval [1] 312148 0
18/11/2022
Approval date [1] 312148 0
05/09/2023
Ethics approval number [1] 312148 0
H-2022-0386

Summary
Brief summary
Addictive eating is a behaviour that contributes to excess energy intake (calories) and is associated with overweight and obesity trajectories, a major health problem affecting over 60% of young adult Australians and is a key risk factor for cardiovascular disease (CVD). Moreover, addictive eating is associated with depression and anxiety, which is the leading cause of disability and premature death in Australia. In these instances, food may be used to reinforce comfort and/or to stabilise mood. Approximately one in five individuals with CVD suffer from depression, while one in four suffer from anxiety. Our research illustrates that these comorbidities (obesity and mental health) cluster together, which if better understood, could be targeted more effectively through better identification and assessment to trial tailored novel interventions for addictive eating. Current guidelines for obesity and CVD focus on reducing energy and saturated/trans-fat, rather than eating behaviours. Despite the extent of obesity and CVD, interventions to treat CVD risk factors are only moderately effective in the short-term.

There is a need for effective behavioural approaches for addictive eating for CVD prevention. The proposal builds upon previous research (ACTRN12619001540101, ACTRN12621001079831) to determine the feasibility of a personality-based intervention for young adults with addictive eating, in a 3-month trial. It will be delivered using technologies, including telehealth, a website, text messages and email. This approach means the program can be delivered anywhere in Australia to individuals in any location. This trial will enable a better understanding of the relationship between CVD and problematic eating behaviours, assist the generation of new treatment principles and enhancement of identification and assessment of at-risk individuals and transitioning them to the right intervention for their condition.
Trial website
www.tracedieteticsyoungadults.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123650 0
Prof Tracy Burrows
Address 123650 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 123650 0
Australia
Phone 123650 0
+61 02 4921 5514
Fax 123650 0
Email 123650 0
tracy.burrows@newcastle.edu.au
Contact person for public queries
Name 123651 0
Dr Janelle Skinner
Address 123651 0
University of Newcastle, University Drive,Callaghan NSW 2308
Country 123651 0
Australia
Phone 123651 0
+61 02 4921 5514
Fax 123651 0
Email 123651 0
janelle.skinner@newcastle.edu.au
Contact person for scientific queries
Name 123652 0
Dr Janelle Skinner
Address 123652 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 123652 0
Australia
Phone 123652 0
+61 02 4921 5514
Fax 123652 0
Email 123652 0
janelle.skinner@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
No additional documents have been identified.