Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001244897
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
15/09/2021
Date last updated
13/04/2024
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of an eHealth prevention and early intervention program targeting eating disorder symptoms in adults.
Scientific title
The efficacy of an eHealth prevention and early intervention program targeting eating disorder symptoms in adults.
Secondary ID [1] 304973 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 323123 0
Condition category
Condition code
Mental Health 320700 320700 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Web- and app-based Interventions for Reducing Eating Disorders (WIRED) project are developing a 10-week individual intervention, delivered via our smartphone app. The 10-week app-based intervention (titled SEED) includes text, audio, and visual content adapted from the research team’s prior trials: (i) cognitive behavioural techniques (including dissonance techniques) to challenge disordered eating thought patterns and encourage healthy lifestyle choices to supplant eating disorder (ED) behaviours; (ii) psycho-education about healthy eating and exercise habits and dangers of EDs; (iii) media literacy development to reduce social media influence on ED symptoms; and (iv) acceptance and mindfulness relaxation to disrupt the influence of negative mood on binge eating. In total, there will be 8 modules of content, each expected to take about 1-2 hours per week to complete.

Our study is an RCT with three arms: waitlist control, WIRED-matched, and WIRED self-guided.
Our study involves three phases:
Phase 1 involves self-report measures via a web-based survey (hosted by Qualtrics) and a phone interview to confirm level of eating disorder symptoms. The phone interview will be conducted by a research assistant who has been trained by clinical staff within the team to use the screening interview tool. The initial interview will last approximately 15-30 minutes.
Phase 2 is the 10-week intervention with three arms: (1) waitlist control, (2) self-guided use of the app intervention, and (3) matched / guided app use based on symptom profile at baseline. Adherence to the app will be monitored automatically through the app. If participants have not used the app within a specific time period (e.g., 1-week), the app will send a notification to the participant to prompt them to use the app.
Phase 3 involves completing the baseline survey again immediately post-intervention, and at 6- and 12-months post-intervention to observe maintenance and continued improvement in symptom reduction. At each of these timepoints, participants will also receive a phone call check-in with a research assistant on the project to see how they are going, and to remind them to complete the current survey. At the immediate post-intervention point, this phone call will also involve reassessment of ED symptom levels. The immediate post-intervention phone interview will be shorter than the baseline interview, taking approximately 10-15 minutes. The check-in phone calls at 6- and 12-month follow-up will likely be very brief as they’re primarily used to remind the participant to complete the online survey.
The intervention content is the same for both the WIRED-matched and WIRED-self-guided arms, though the order and prioritisation of content will be different as WIRED-matched tailors the content delivery to most pressing needs based on symptoms at baseline.
Intervention code [1] 321362 0
Behaviour
Comparator / control treatment
A waitlist control will be used, whereby participants will not receive the app during the whole 10-week intervention phase.
Control group
Active

Outcomes
Primary outcome [1] 328513 0
Eating disorder diagnosis
Timepoint [1] 328513 0
EDE interview - At baseline and post-intervention only
EDE-Q - At 6- and 12-month follow-up
Primary outcome [2] 328822 0
The Eating Pathology Symptoms Inventory (EPSI)
Timepoint [2] 328822 0
At all timepoints: baseline, immediately post-intervention (primary timepoint), and at 6- and 12-months post-intervention.
Secondary outcome [1] 399301 0
Quality of life (AQoL-4D)
Timepoint [1] 399301 0
At all timepoints (baseline, immediately post-intervention, and at 6- and 12-months post-intervention).
Secondary outcome [2] 399302 0
Psychological flexibility assessed using the Body Image Flexibility subscale of the Body Image-Acceptance and Action Questionnaire
Timepoint [2] 399302 0
At all timepoints (baseline, immediately post-intervention, and at 6- and 12-months post-intervention).
Secondary outcome [3] 399303 0
Internalisation of appearance ideals (SATAQ-4R)
Timepoint [3] 399303 0
At all timepoints (baseline, immediately post-intervention, and at 6- and 12-months post-intervention).
Secondary outcome [4] 399304 0
Health economics (direct linkage to MBS/PBS healthcare usage data)
Timepoint [4] 399304 0
At all timepoints (baseline, immediately post-intervention, and at 6- and 12-months post-intervention).

Eligibility
Key inclusion criteria
Adults aged 18 and over who may have a subclinical or full eating disorder diagnosis for the main ED subtypes, specifically bulimia nervosa (BN), binge eating disorder (BED), body dysmorphia disorder (BDD; specific to dysmorphia with the body rather than face), other specified feeding or eating disorder (OSFED), and unspecified feeding or eating disorder (UFED). Diagnosis information will be self-reported in the baseline survey and a clinical phone interview will also be completed to determine eligibility.

In addition, the baseline online survey includes several screening questions to identify those who will probably meet the clinical/subclinical threshold for inclusion into the study. These items ask whether participants have dieted during the past 6 months, and whether they have been concerned about their body, body image, or physical appearance during the past 6 months. These two items are based on prior eHealth interventions for body image and ED, and provide a good screener to reduce the number of phone interviews required overall.

Finally, access to a smartphone throughout duration of 10-week intervention phase of research participation is a necessary inclusion criterion for the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with a diagnosis of (or symptoms consistent with) Anorexia Nervosa (AN; including Atypical AN), Avoidant/restrictive food intake disorder (ARFID), Pica, Rumination Disorder, and BDD (specific to dysmorphia related to facial rather than bodily appearance) will not be eligible to participate. These individuals will instead be provided with referral information for treatment and support.

Our baseline survey includes a question about suicidality (‘Over the last 2 weeks, how often have you had thoughts that you would be better off dead or hurting yourself in some way?’). Participants who answer above zero (“not at all”) will be excluded from the study, and instead recommended free counselling options such as lifeline, as well as being made aware of GP referral to psychologists.

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)
Participants will be randomised via the survey software Qualtrics, where the app download instructions are presented to participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We aim to obtain equivalent groups at baseline based on randomization to the three arms of the study. Randomization will be achieved through Qualtrics on a 1:1:1 basis. As this is done once the participants complete the baseline survey, and automated by simple randomization through Qualtrics itself, the researchers will not bias randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant total will be 576 (including men and women) who report subclinical or clinical levels of ED symptoms. The figure of 576 individuals is based on a power analysis with the following assumptions: a standardized mean difference of .3 between the two intervention groups (and higher for comparisons against the waitlist control) as per prior studies, power set at .80, alpha = .05 (two-tailed), and attrition rate of 25% at follow-up.
Multiple imputation (MI) will be used to handle missing data, and pattern mixture models to conduct sensitivity analyses to evaluate plausibility of Missing At Random assumptions for MI. We will analyse the data using multilevel modelling in a statistical analysis package.
Analyses will follow the ‘intention to treat’ principle. To account for attrition, analysis of the primary outcome and all secondary outcomes will be carried out using mixed effects regression. For each outcome, a single linear mixed effects model will be fitted incorporating baseline, post-intervention, and 6 and 12 month follow-up data using random effects to allow for the repeated measures within an individual. This model will fit random effects and error terms, and fixed effects of treatment at each time point. This approach implicitly deals with missing data by including all participants with baseline data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
576
Accrual to date
520
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309359 0
Government body
Name [1] 309359 0
Million Minds Mental Health Research Mission grant from the National Health and Medical Research Council - (APP1179321)
Country [1] 309359 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 310329 0
None
Name [1] 310329 0
Address [1] 310329 0
Country [1] 310329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309175 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309175 0
Ethics committee country [1] 309175 0
Australia
Date submitted for ethics approval [1] 309175 0
25/06/2019
Approval date [1] 309175 0
03/09/2019
Ethics approval number [1] 309175 0
2019-266

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

Contacts
Principal investigator
Name 113246 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 113246 0
School of Psychology, Faculty of Health, Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 113246 0
Australia
Phone 113246 0
+61 3 925 17344
Fax 113246 0
Email 113246 0
[email protected]
Contact person for public queries
Name 113247 0
Hannah Jarman
Address 113247 0
School of Psychology, Faculty of Health, Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 113247 0
Australia
Phone 113247 0
+61 3 925 17344
Fax 113247 0
Email 113247 0
[email protected]
Contact person for scientific queries
Name 113248 0
Hannah Jarman
Address 113248 0
School of Psychology, Faculty of Health, Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 113248 0
Australia
Phone 113248 0
+61 3 925 17344
Fax 113248 0
Email 113248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share data.


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.