Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001277336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/10/2026
Date registered
Help: Date registered
23/10/2026
Date last updated
Help: Date last updated
23/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Can a single session on functional nutrition and goal planning reduce disordered eating in young adults with high weight concern?
Scientific title
Effects of a functional nutrition single-session intervention with mental contrasting, compared with assessment-only control, on disordered eating and body image flexibility in young adults with elevated weight concern
Additional trial identifiers [1] 318565 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12626000397314 - parent trial

Randomised trial comparing two single-session functional nutrition psychoeducation interventions (with indulging, and with mental contrasting) against a control condition. Its findings informed the design of the present trial.

Health condition
Health condition(s) studied:
Eating disorders 343763 0
Condition category
Condition code
Mental Health 339891 339891 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Functional nutrition is psychoeducation about the biological benefits of nutrition, accompanied by a simple message: eat carbohydrates regularly throughout the day. An earlier trial evaluated the effects of a related psychoeducation handout, which explained the neurobiology of eating disorders and included the message that eating regularly is helpful (Zhou et al., 2020). In young women at risk of developing an eating disorder, the handout reduced global eating psychopathology (d = 0.73) and improved body image acceptance (d = 0.78) at one-week follow-up, relative to control. A subsequent trial (ACTRN12626000397314) compared a control condition with two single-session interventions: functional nutrition psychoeducation with a goal-setting exercise (indulging), and functional nutrition psychoeducation with a goal-setting exercise plus mental contrasting. The present randomised trial compares a revised version of the functional nutrition single-session intervention, designed to be more engaging and to address body image concerns that may arise when increasing food intake, with an assessment-only control condition in young adults with elevated weight concern.

The intervention is a digital, self-guided, single-session program with no facilitator. It was developed by Professor Tracey Wade, a clinical psychologist with extensive research experience in eating disorders. It is delivered online via PowerPoint slides embedded in the Qualtrics survey platform.

The psychoeducation, framed within a growth mindset message, covers neuroplasticity, epigenetics, the gut-brain axis and the effects of dieting on the developing brain, and recommends at least four serves of carbohydrates across the day. Participants then complete a goal-setting exercise based on mental contrasting. They respond in writing to prompts asking for one way they want to change their eating over the next week, what will be happening differently if they do this, and an obstacle that may interfere with their plan. A final prompt asks how they will overcome this obstacle.

Participants complete the intervention once, immediately after the baseline assessment (T1), and it takes approximately 15 minutes. Follow-up assessments occur at one week (T2) and four weeks (T3) post-randomisation.

Adherence to the intervention will be monitored through Qualtrics response data. Completion will be verified by participants’ written responses to the goal-setting prompts and by page timing data, which records the time spent on each intervention page. No homework is assigned.
Intervention code [1] 335472 0
Behaviour
Intervention code [2] 335473 0
Prevention
Description of the comparator or control
Participants in the control condition do not receive an intervention. They complete the baseline assessment and the same follow-up assessments at the same time points as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 347069 0
Disordered eating cognitions
Timepoint [1] 347069 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Primary outcome [2] 347071 0
Body image flexibility
Timepoint [2] 347071 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [1] 468771 0
Eating disorder behaviours
Timepoint [1] 468771 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [2] 468774 0
Anxiety symptoms
Timepoint [2] 468774 0
Baseline, 1 week post randomisation, and 4 weeks post-randomisation
Secondary outcome [3] 468775 0
Psychological distress
Timepoint [3] 468775 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [4] 468776 0
Suicidal ideation
Timepoint [4] 468776 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [5] 468777 0
Hope
Timepoint [5] 468777 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [6] 468778 0
Carbohydrate intake
Timepoint [6] 468778 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation
Secondary outcome [7] 469091 0
Depression symptoms
Timepoint [7] 469091 0
Baseline, 1 week post-randomisation, and 4 weeks post-randomisation

Eligibility
Key inclusion criteria
(1) able to read and write in English; (2) aged 18 to 25 years; (3) access to the internet and a device capable of completing the study measures; (4) recruited through the Prolific research platform and residing in Australia; and (5) a score of 47 or above on the Weight Concerns Scale (WCS; Killen et al., 1994; Radunz et al., 2026), administered as a pre-screening questionnaire on Prolific.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. Participants are randomised automatically within Qualtrics after completing the baseline assessment, so neither participants nor researchers can influence allocation in advance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation function on Qualtrics Survey platform.
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
Sample size was determined by power analysis using RMASS2 (Hedeker et al., 1999) for a two-group repeated measures design with three time points (baseline, one-week and four-week follow-up). Assuming a between-group effect size of d = 0.25 on the EDE-Q7, based on a previous trial of the intervention, a correlation of .50 between repeated measures, alpha = .05 (two-sided), power = .80, equal allocation, and retention of 77% at one week and 75% at four weeks (based on Robinson et al., 2024), 196 participants per group (N = 392) are required at baseline. Outcomes will be analysed using linear mixed models examining the group × time interaction, which use all available data under a missing-at-random assumption.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 323145 0
Government body
Name [1] 323145 0
National Health and Medical Research Council
Country [1] 323145 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 326152 0
None
Name [1] 326152 0
Address [1] 326152 0
Country [1] 326152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321548 0
Flinders University Human Research Ethics Committee A
Ethics committee address [1] 321548 0
Ethics committee country [1] 321548 0
Australia
Date submitted for ethics approval [1] 321548 0
18/03/2026
Approval date [1] 321548 0
23/04/2026
Ethics approval number [1] 321548 0
9642

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

Contacts
Principal investigator
Name 154038 0
Mr Josh Carey
Address 154038 0
Flinders University, Sturt Road, Bedford Park SA 5042
Country 154038 0
Australia
Phone 154038 0
+61 8 8201 3736
Fax 154038 0
Email 154038 0
[email protected]
Contact person for public queries
Name 154039 0
Tracey Wade
Address 154039 0
Flinders University, Sturt Road, Bedford Park SA 5042
Country 154039 0
Australia
Phone 154039 0
+61 8 8201 3736
Fax 154039 0
Email 154039 0
[email protected]
Contact person for scientific queries
Name 154040 0
Tracey Wade
Address 154040 0
Flinders University, Sturt Road, Bedford Park SA 5042
Country 154040 0
Australia
Phone 154040 0
+61 8 8201 3736
Fax 154040 0
Email 154040 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.