Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000614594p
Ethics application status
Submitted, not yet approved
Date submitted
20/04/2024
Date registered
10/05/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes and the Mediterranean or standard diet (DIAMOND) - A simplified Mediterranean diet-based intervention for patients with diabetes in a primary care setting.
Scientific title
Diabetes and the Mediterranean or standard diet (DIAMOND)- A simplified Mediterranean diet-based interventional trial for glycemic control in patients with type 2 diabetes in a primary care setting.
Secondary ID [1] 312002 0
NIl known
Universal Trial Number (UTN)
Trial acronym
DIAMOND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 333613 0
Condition category
Condition code
Metabolic and Endocrine 330301 330301 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients included will be randomly allocated into one of the two study arms namely the usual care (UC, n=30) and the Mediterranean Diet (MD, n=30) group. All patients: will receive an initial telephone call from the researcher that will be approx. 25-30 minutes. During this call intervention group (MD group) will receive a structured simplified MD-based nutrition intervention. This will be delivered by a primary care practitioner (either general practitioner or nurse practitioner) in the form of a one-to-one telephone consultation with the patient. No specific behavioural change counselling strategies will be used by the practitioner during the nutrition intervention (this is to keep the intervention simple and deliverable by any healthcare practitioner). The consultation delivering the intervention will take approx. 20 minutes and will provide education covering four key concepts in the MD diet (recommending the consumption of legumes, nuts, low glycemic index carbohydrates and fermented dairy). Following the telephone consultations, patients will be given a link to online resources including recipe ideas and visual reminders to facilitate intervention adherence. These resources are specifically developed for this study based on the Mediterranean diet pyramid. They will also receive fortnightly text messages summarising the health messages discussed during the telephone consultation for the 6-month intervention duration. During the last 5-10 minutes of the telephone call, participants will be reminded to make routine visits to the GP and perform routine blood tests. The participants' adherence to intervention will be determined by comparing the responses to the Mediterranean Diet Adherence Screener questionnaire and a 24-hour dietary recall obtained (online) at the baseline and 6 months since recruitment.
Intervention code [1] 328458 0
Lifestyle
Comparator / control treatment
The usual care group will also receive a brief one-to-one 10-minute telephone consultation from a primary care practitioner recommending they follow the Australian Guide to Healthy Eating. Following this they will receive a text message with a link to the website (Australian Guide to Healthy Eating). No follow-up text messages will be sent to these patients until the end of the study. During the last 5-10 minutes of the telephone call, participants will be reminded to make routine visits to the GP and perform routine blood tests.
Control group
Active

Outcomes
Primary outcome [1] 338043 0
Glycemic control
Timepoint [1] 338043 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [1] 434295 0
Blood glucose level
Timepoint [1] 434295 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [2] 434296 0
Blood lipid profile
Timepoint [2] 434296 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [3] 434297 0
Liver function
Timepoint [3] 434297 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [4] 434298 0
Anthropometry
Timepoint [4] 434298 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [5] 434299 0
Blood pressure regulation
Timepoint [5] 434299 0
Baseline and after 6 months since recruitment in the study
Secondary outcome [6] 434673 0
Liver function
Timepoint [6] 434673 0
Baseline and after 6 months since recruitment in the study

Eligibility
Key inclusion criteria
1) presented to GP and had a diagnosis of type 2 diabetes by a medical practitioner 2) not have been on medications that interfere with glucose tolerance (beta blockers, antidepressants, antibiotics, oestrogens, prednisolone) in the past two months 3) managing diabetes with common medications (except for insulin)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Pregnant or lactating 2) any serious terminal illness (cancer, live cirrhosis, severe gastrointestinal disease, renal failure (glomerular filtration rate < 60) 3) alcohol abuse (ie.>30 doses/week) 4) received dietary advice from a nutrition professional in the last month 5) weight loss greater than or equal to 5 kg in the last three months

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a secured REDCap application (randomisation program will be created by a bio-statistician)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analysis will be conducted using SPSS or Stata Statistical Software. All data will be initially analysed using an intention-to-treat approach. Wherever possible, all data from every randomised patient will be included in analyses. Linear mixed models will be used to test between-group intervention effects. Paired t-tests will be used to test for within-group changes over time. Normality and homogeneity of variance of the residuals will be checked using quantile-quantile plots and scatterplots respectively, before analysis. Significance will be set at P<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316346 0
University
Name [1] 316346 0
Deakin University
Country [1] 316346 0
Australia
Funding source category [2] 316349 0
Other Collaborative groups
Name [2] 316349 0
Baker heart and diabetes institute
Country [2] 316349 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318536 0
Other Collaborative groups
Name [1] 318536 0
Baker heart and diabetes institute
Address [1] 318536 0
Country [1] 318536 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315157 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 315157 0
Human Research Ethics Office Deakin University 221 Burwood Hwy Burwood, VIC 3125 +61 9251 7129, email: research-ethics@deakin.edu.au.
Ethics committee country [1] 315157 0
Australia
Date submitted for ethics approval [1] 315157 0
22/03/2024
Approval date [1] 315157 0
Ethics approval number [1] 315157 0
2024-103

Summary
Brief summary
This study aims to determine the changes in blood glucose level control over six months following a simplified Mediterranean diet-based nutrition intervention compared to usual care among Australian adults diagnosed with type 2 diabetes. A healthcare practitioner in the primary care setting (GP or nurse) will deliver the intervention via telephone consultations and online media. Blood test results and other outcome measures of patients will be obtained from their registered general practice. We expect that patients receiving the nutrition intervention will have a greater improvement in blood glucose control, blood cholesterol levels, liver function, body weight and blood pressure compared to the patients in the usual care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133854 0
Dr Elena George
Address 133854 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 133854 0
Australia
Phone 133854 0
+61 3 924 68622
Fax 133854 0
Email 133854 0
elena.george@deakin.edu.au
Contact person for public queries
Name 133855 0
Elena George
Address 133855 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 133855 0
Australia
Phone 133855 0
+61 3 924 68622
Fax 133855 0
Email 133855 0
elena.george@deakin.edu.au
Contact person for scientific queries
Name 133856 0
Elena George
Address 133856 0
Deakin University Institute for Physical Activity and Nutrition 221 Burwood Highway Burwood VIC 3125
Country 133856 0
Australia
Phone 133856 0
+61 3 924 68622
Fax 133856 0
Email 133856 0
elena.george@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.