None listed
Conditions
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.
Interventions
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
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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.
Outcome results
None listed