Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000177752
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of changing eating behaviours on mood
Scientific title
The effect of an online diet intervention on depression symptoms in young adults with elevated depression symptoms who habitually consume a Western-style diet
Secondary ID [1] 305634 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 324061 0
Poor diet 325025 0
Condition category
Condition code
Mental Health 321574 321574 0 0
Depression
Diet and Nutrition 322460 322460 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves provision of diet recommendations and resources via a video (approximately 13 minutes) and written resources that were designed in collaboration with a dietitian for the purposes of this study. The fresh food (FF) group will be shown a video providing instructions regarding diet administered by a registered dietician. They will be provided diet recommendations in keeping with the Australian Guide to Healthy eating. Participants will be provided a link to a website to access the video and educational resources, which will be developed specifically for this study (via Google Sites). They will be asked to follow the diet for 4 weeks. They will be provided a sample meal plan, recipes, vouchers to cover the increase in their food costs, and weekly text contact to aid compliance.
Intervention code [1] 322031 0
Treatment: Other
Intervention code [2] 322697 0
Lifestyle
Comparator / control treatment
The Comfort Cooking (CC) group will be provided instructions on cooking comfort foods, with no focus on nutritional information. They will be shown a video providing instructions regarding increasing the amount they cook comfort foods, which is matched in length to the video shown to the FF group. Participants will be provided a link to a website to access the video and educational resources, which will be developed specifically for this study (via Google Sites). They will be asked to follow the diet for 4 weeks. They will be provided a sample meal plan, recipes, vouchers to cover the increase in their food costs, and weekly text contact to aid compliance. Thus, the CC control group will be matched for time/effort/contact, but with little change in the macronutrient profile of their diet.
Control group
Active

Outcomes
Primary outcome [1] 329342 0
Depression symptoms as measured using the Public Health Questionnaire-9 (PHQ-9).
Timepoint [1] 329342 0
Baseline and 4 weeks post-intervention commencement.
Secondary outcome [1] 402201 0
Anxiety symptoms as measured using the Generalised Anxiety Disorder-7 questionnaire (GAD-7).
Timepoint [1] 402201 0
Baseline and 4 weeks post-intervention commencement.
Secondary outcome [2] 402202 0
Consumption of Western-style diet as measured using the Dietary Fat and added Sugar screener (DFS).
Timepoint [2] 402202 0
Baseline and 4 weeks post-intervention commencement.
Secondary outcome [3] 402203 0
Change in intake of recommended food groups consistent with the Australian Guide to Health Eating using the Diet Compliance Survey (DCS).
Timepoint [3] 402203 0
Baseline and 4 weeks post-intervention commencement.
Secondary outcome [4] 402204 0
Change in macronutrient composition as measured using a food frequency questionnaire.
Timepoint [4] 402204 0
Baseline and 4 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Aged 18-25, score >23.6 on the PANAS negative affect subscale; Score > 57 on the Dietary Fat and Sugar Screener (DFS).
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Very severe depression (i.e., indicated by a score > 25 on the PHQ-9), significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9), pregnant women, currently dieting, history of eating disorders or metabolic disease(s), history of psychological illness other than depression or anxiety, medical condition that could be adversely affected by diet change, inability to use a computer, self-reported current or recent illicit drug use or alcohol use, sickness in the past week. If receiving antidepressant medication or therapy, on the same treatment for at least 2 weeks before study participation.

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)
The psychologist who will determine subject eligibility will not be aware of the condition the participant is allocated to. Allocation will be conducted by a research assistant who is responsible for the allocation schedule, and is not involved in determining subject eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation to ensure gender balance across groups will be employed. An independent website, www.random.org, will be used to generate a list of randomly generated numbers, with a separate randomisation schedule for males and females to ensure gender is matched between groups. Participants will be associated with a randomisation number prior to the first baseline zoom session and assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309994 0
University
Name [1] 309994 0
Macquarie University
Country [1] 309994 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 311045 0
None
Name [1] 311045 0
Address [1] 311045 0
Country [1] 311045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309703 0
Macquarie University Human Research Ethics Committee Human Science and Humanities
Ethics committee address [1] 309703 0
Ethics committee country [1] 309703 0
Australia
Date submitted for ethics approval [1] 309703 0
Approval date [1] 309703 0
14/12/2021
Ethics approval number [1] 309703 0
520211071035608

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

Contacts
Principal investigator
Name 115098 0
Dr Heather Francis
Address 115098 0
Room 510, 4 First Walk, Macquarie University, Macquarie Park NSW 2109
Country 115098 0
Australia
Phone 115098 0
+61 2 9850 1808
Fax 115098 0
Email 115098 0
[email protected]
Contact person for public queries
Name 115099 0
Heather Francis
Address 115099 0
Room 510, 4 First Walk, Macquarie University, Macquarie Park NSW 2109
Country 115099 0
Australia
Phone 115099 0
+61 2 9850 1808
Fax 115099 0
Email 115099 0
[email protected]
Contact person for scientific queries
Name 115100 0
Heather Francis
Address 115100 0
Room 510, 4 First Walk, Macquarie University, Macquarie Park NSW 2109
Country 115100 0
Australia
Phone 115100 0
+61 2 9850 1808
Fax 115100 0
Email 115100 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:
• Searchable to any researcher.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Summed scores for the primary outcomes, for each timepoint. No identifying information will be provided.

What types of analyses could be done with individual participant data?
• Any purpose.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Macquarie University Data Repository (https://figshare.com).

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.