Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000693729p
Ethics application status
Submitted, not yet approved
Date submitted
16/02/2022
Date registered
13/05/2022
Date last updated
26/05/2022
Date data sharing statement initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
BeNEFIT: Bringing eHealth Nutrition Education to populations For Improved depression Treatment
Scientific title
Investigation of the effect and cost-effectiveness of nutrition education facilitated through an mHealth program on depressive symptoms in adults.
Secondary ID [1] 306453 0
None
Universal Trial Number (UTN)
Trial acronym
BeNEFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 325291 0
Condition category
Condition code
Mental Health 322690 322690 0 0
Depression
Public Health 323491 323491 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Mediterranean diet intervention, delivered via a mobile application. The program consists of modules containing video content and weekly goal setting activities. The mobile application has been specifically designed for this trial by a third party provider, Sophus. The design of the application is based on a prototype developed in-house and piloted with 150 participants and also the base design of the Sophus' own application.

The program contains 12 short videos, where Prof Felice Jacka discusses the benefits of The Mediterranean Diet for mental and brain health. Then, Dr Rachelle Opie, a researcher from our centre and Accredited Practising Dietitian, discussed the key components of the Mediterranean Diet and gives practical advice on how participants can incorporate these components into their diet.

The topics in this program are:
1. Introduction: The Mediterranean Diet and the link to mental health
2. How can I successfully make changes to my diet?
3. Plant foods: fruit and vegetables
4. Plant foods: legumes
5. Plant foods: wholegrains
6. Healthy fats of the Mediterranean diet
7. Fish and seafood
8. Other important dietary components (herbs and spices, fermented foods)
9. Other food groups (red meat, dairy)
10. Extras / Discretionary Foods
11. The Mediterranean lifestyle (social eating, exercise and alcohol)
12. Summary
This app also sends reminders, during the four week study, to ensure participants have watched the videos, set a weekly goal and are monitoring their diet.

The participants are encouraged to watch the videos within the first week of the study (approx 1 hour) then set a weekly goal and review additional materials such as recipes and blog posts relevant to the program.

During the course of the trial the research team will monitor engagement through app access and usage and also completion of week 2 and week 4 measures.

The study intervention is solely based on the application, there is no food supply or direct consultation.
Intervention code [1] 322882 0
Lifestyle
Intervention code [2] 323500 0
Treatment: Other
Comparator / control treatment
Control group: Control nutrition education program, delivered via a mobile application. The program consists of modules containing video content and weekly quiz activities.

The program contains 12 short videos, where Prof Felice Jacka, discusses the benefits and evidence of different nutrition components for mental health. Then, Dr Rachelle Opie, a researcher from our centre guides you through specific vitamins and supplements and what research says about their benefits.

The topics in this program are:
1. Introduction
2. Safety advice
3. Magnesium and mental health
4. Zinc and mental health
5. Vitamin C and mental health
6. Folate and mental health
7. Vitamin D and mental health
8. Multivitamins and mental health
9. Carnitine and mental health
10. L-theanine and mental health
11. N-acetyl cysteine and mental health
12. Summary

The participants are encouraged to watch the videos within the first week of the study (approx 1 hour) then answer a weekly quiz and review additional materials such as blog posts relevant to the program.

During the course of the trial the research team will monitor engagement through app access and usage and also completion of week 2 and week 4 measures.

This app also sends reminders, during the four week study, to make sure participants have watched the videos and completed the weekly activities.

The control intervention is solely based on the application, there is no food supply, vitamin supply or direct consultation.
Control group
Active

Outcomes
Primary outcome [1] 330489 0
Change in depressive symptoms, as measured by the 8-item Patient Health Questionnaire (PHQ-8)
Timepoint [1] 330489 0
Week 4 after baseline measures have been completed at point of consent.
Secondary outcome [1] 406402 0
Diet quality as measured by the Mediterranean Adherence Screener (MEDAS)
Timepoint [1] 406402 0
Week 4 after baseline measures have been completed at point of consent.
Secondary outcome [2] 409343 0
Anxiety symptoms as measured by the General Anxiety Disorder (GAD-7)
Timepoint [2] 409343 0
Week 4 after baseline measures have been completed
Secondary outcome [3] 409344 0
Gut symptoms as measured by the Gastrointestinal Symptom Rating Scale and Bristol Stool Chart (composite secondary outcome)
Timepoint [3] 409344 0
Week 2 and Week 4 after baseline measures have been completed on consent
Secondary outcome [4] 409345 0
Expectation bias as measured by the Credibility expectation questionnaire
Timepoint [4] 409345 0
Week 4 after baseline measures completed on consent
Secondary outcome [5] 409346 0
Lifestyle changes as measured by the Sleep, smoking, physical activity and stress questionnaire designed for this trial.
Timepoint [5] 409346 0
Week 4 after baseline measures have been completed on consent
Secondary outcome [6] 409347 0
Global impression of improvement as measured by the Global impression of improvement (PGI-I)
Timepoint [6] 409347 0
Week 4 after baseline measures have been completed on consent
Secondary outcome [7] 409348 0
Resource use as measured by the Change in medication use and treatment and Resource use questionnaires (composite secondary outcome)
Timepoint [7] 409348 0
Week 4 after baseline measures have been completed on consent
Secondary outcome [8] 409349 0
Engagement as measured by system event logs from the BeNEFIT mHealth application
Timepoint [8] 409349 0
Ongoing throughout the 4 week trial
Secondary outcome [9] 409350 0
Motivation and readiness to change as measured by the Motivation and readiness to change questionnaire
Timepoint [9] 409350 0
Week 4 after baseline measures completed on consent
Secondary outcome [10] 409351 0
Gut microbiota composition/function as measured by Microba gut microbiome analysis for a subset of 100 participants, participants supply stool samples for this analysis at baseline and week 4
Timepoint [10] 409351 0
Week 4 after baseline measures have been completed

Eligibility
Key inclusion criteria
Community-dwelling adults (age 18-65)
Depressive symptoms of at least mild severity (PHQ-8 greater than or equal to 5)
Access to internet and a smartphone or tablet
Ability to understand study materials and directions in English
Ability to download the mobile application from a respective app store
Ability to enter login details provided to access the mobile application
Agree not to enrol in another interventional clinical research trial while part of the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently following a Mediterranean diet (greater than or equal to 11 on MEDAS at baseline) (Downer et al., 2016)
Individuals who are pregnant or breastfeeding, or who are intending to become pregnant
Individuals prescribed warfarin, heparin and other anti-coagulant medications
Individuals on immune-suppressing medication
Individuals receiving chemotherapy or radiotherapy
Individuals with a diagnosis of liver disease
Individuals with a diagnosis of kidney disease
Individuals with a diagnosed eating disorder
Individuals who have received medical advice to avoid vitamin, mineral or fish oil supplementation
Individuals who have commenced nutrient supplementation (vitamins, minerals, and/or fish oil) in the last month
Underweight (i.e. BMI less than 18.5)
Inability to follow Mediterranean diet study recommendations (i.e. currently vegan or paleo-style diet; inability to follow diet for sociocultural or religious reasons)
Diagnosed with or commenced new treatment for, anxiety and/or depression, within 1 month prior to baseline. Stable pharmacological or other therapy for more than one-month prior will not be an exclusion criterion.

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)
Allocation to treatment arms will be randomly assigned in a 1:1 ratio using permutated stratified randomisation. Allocation will be performed automatically by computer and concealed for the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher will develop the computer-generated randomisation sequence to generate a randomisation table using random block sizes, which will be partitioned by 2 strata. Randomisation will be stratified by country and baseline depression severity (a-priori cut-offs at baseline: A total score of 0 to 9 represents no or mild depressive symptoms; 10 to 14, moderate; and 15 to 24, moderately severe or severe).
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
Between-group differential change from baseline to week 4 in depressive symptoms, as measured by the eight-item Patient Health Questionnaire (PHQ-8), will be the primary endpoint.

To examine the primary hypotheses, in addition to overall comparison, a GEE model per PHQ-8 baseline strata for the continuous PHQ-8 outcome will be implemented. The GE models will utilize a robust sandwich estimator with unspecified covariance structure to account for within participants’ autocorrelation. The GEE models will include the fixed categorical effects of treatment, visit (baseline/ week 4), and treatment-by-visit interaction, as well as the fixed factor of participants country. The two-way treatment-by-visit interactions at week 4 follow-up will estimate the between-group differential changes in PHQ-8 to address the primary comparison.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
672
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24584 0
New Zealand
State/province [1] 24584 0
Country [2] 24585 0
United Kingdom
State/province [2] 24585 0
Country [3] 24586 0
United States of America
State/province [3] 24586 0

Funding & Sponsors
Funding source category [1] 310803 0
University
Name [1] 310803 0
Deakin University
Country [1] 310803 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road, Waurn Ponds, Victoria 3216
Country
Australia
Secondary sponsor category [1] 312046 0
None
Name [1] 312046 0
Address [1] 312046 0
Country [1] 312046 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310372 0
Deakin University Health Research Ethics Committee
Ethics committee address [1] 310372 0
The Human Research Ethics Office,
Deakin University,
221 Burwood Highway,
Burwood Victoria 3125
Ethics committee country [1] 310372 0
Australia
Date submitted for ethics approval [1] 310372 0
17/11/2021
Approval date [1] 310372 0
Ethics approval number [1] 310372 0

Summary
Brief summary
BeNEFIT is a 4-week, international, randomised controlled trial designed to test whether adherence to a Mediterranean diet mHealth program is efficacious and cost-effective for improving depressive symptoms, compared with an m-Health control nutrition program.

Community-dwelling adults (age 18-65), from Australia, New Zealand the United States and United Kingdom, with at least mild depression severity and who currently do not follow a Mediterranean diet or have conditions that prohibit the use of nutrition supplements will be recruited online.

The Intervention consists of a Mediterranean diet education program, delivered via a mobile application. The program consists of modules containing video content and weekly goal setting activities.

The control group will receive a control nutrition education program, also delivered via a mobile application. The program consists of modules containing video content and weekly quiz activities.

We anticipate that the mHealth Mediterranean diet intervention will be effective compared to a mHealth control nutrition education program in improving self-reported depressive symptoms at 4 weeks.
Trial website
Trial related presentations / publications
Public notes
The recent randomised controlled trial evidence that improving diet quality through a Mediterranean diet can reduce depressive symptoms, and the evidence of the effectiveness of mHealth interventions in depression provide strong grounds for further research. There is a clear need to now extend our knowledge in the field of Nutritional Psychiatry in order to develop new, scalable, intervention strategies to improve outcomes for patients and the wider population. This research is important as an mHealth intervention presents an opportunity to positively impact the health of many more individuals compared with that possible through traditional face-to-face methods, and is also likely to reach a broader spectrum of individuals that may not usually volunteer for clinical trials due to time constraints or geographical location. In order to test the feasibility of an mHealth dietary intervention program in individuals with depression, we have recently completed a three-year, structured, iterative program for the design, evaluation and optimisation of an online dietary support program. To mitigate the known impact of expectancy effects on study outcomes, we have also developed and evaluated an active control condition based on a ‘placebo’ nutrition education program.

Contacts
Principal investigator
Name 117418 0
Prof Felice Jacka
Address 117418 0
Food & Mood Centre
Health Education Research Building (HERB)
Level 3, 285 Ryrie Street
Geelong, VIC 3220
Country 117418 0
Australia
Phone 117418 0
+61 0422 194 218
Fax 117418 0
Email 117418 0
f.jacka@deakin.edu.au
Contact person for public queries
Name 117419 0
Dr Claire Young
Address 117419 0
Food & Mood Centre
Health Education Research Building (HERB)
Level 3, 285 Ryrie Street
Geelong, VIC 3220
Country 117419 0
Australia
Phone 117419 0
+61 0406754668
Fax 117419 0
Email 117419 0
claire.y@deakin.edu.au
Contact person for scientific queries
Name 117420 0
Dr Heidi Staudacher
Address 117420 0
Food & Mood Centre
Health Education Research Building (HERB)
Level 3, 285 Ryrie Street
Geelong, VIC 3220
Country 117420 0
Australia
Phone 117420 0
+61 0414237657
Fax 117420 0
Email 117420 0
heidi.staudacher@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be stored on OSF.
Primary and Secondary outcome data will be available in the same repository
When will data be available (start and end dates)?
From 1/4/2023 to 1/4/2030
Available to whom?
Public
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By contacting the principal investigator
Prof Felice Jacka
f.jacka@deakin.edu.au


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.