Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000541303
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
18/04/2017
Date last updated
5/04/2024
Date data sharing statement initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The EDGe (End Diabetes Gisborne) trial. Using the whole-foods, plant-based diet in a community programme for people with obesity and diabetes
Scientific title
End Diabetes in Gisborne. A randomised controlled trial using the whole foods plant-based diet with a 10 week community programme for those with both type II diabetes and obesity.
Secondary ID [1] 291303 0
None
Universal Trial Number (UTN)
U1111-1193-4550
Trial acronym
EDGe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II Diabetes 302274 0
Obesity 302275 0
Condition category
Condition code
Metabolic and Endocrine 301867 301867 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study outline

The EDGE study will be a randomised trial with wait-listed control group. It is a prospective, two-arm, parallel, superiority study planned to run from May 2017 to September 2018. We will compare two groups; standard medical care (wait-listed control) to standard medical care plus a diet change programme (intervention).

Summary of intervention

The intervention participants will undergo a 10-week dietary change programme at the local polytechnic. The diet is not personalised to the individuals.

Diet

The whole foods plant-based (WFPB) approach aims to get around 7 – 15% of total energy from fat. Participants will be advised to avoid animal products, including meat, dairy and eggs. Foods emphasised in the programme are whole plant foods such as vegetables, fruits, starches, grains, and legumes. Participants will be advised to eat as much as they like, and to eat until they are comfortably full. There are no restrictions on spices and herbs. A traffic light chart will be provided to participants outlining acceptable foods.

We will provide 50mcg daily vitamin B12 (methylcobalamin) supplements oral drops. If a participant has a history of poor B12 absorption, higher dose tablets (1000mcg daily) will be available, or three monthly injection of 1000mcg Intramuscular will be provided.

Exercise

Participants will be asked to maintain their normal levels of exercise during the programme. There will be no minimum requirements for exercise or formal requirements.

Evening sessions

The evening sessions will be run two nights per week and two hours duration per session (40 hours over 10 weeks). Sessions will be run at a local polytechnic (Eastland Institute of Technology – EIT). Sessions will be divided into one hour of group discussion and one hour of chef-guided cooking classes. Cooking classes involves working with a partner and cooking the food item demonstrated by the chef. Face-to-face evening sessions will build skills such as label reading, cooking, knowledge of pathology of diabetes, how to sustain a lifestyle change, and will focus on enabling group discussion and problem-solving. Full write up of topics discussed in sessions will be included in resulting publication. Information will be presentations will be delivered by trained staff (Doctor and programme director). Through these activities we aim to develop cooking skills in the chef-guided cooking class.

Materials provided

The participants will be given a booklet of lesson summaries and recipes, a cookbook, and a list of restaurants that serve plant-based food. Staff delivering the programme have several years experience with previous dietary / lifestyle interventions and working with patients.

Adherence

Dietary adherence will measured by diet history / recall questionnaires.

Our programme will emphasise support for participants to maintain and improve adherence:

Teaching based on learning theory; spaced repetition, timed, tested.
Involve family members – family/whanau involvement
Potential for use of buddy system (participants buddy up with another person to support one another).
Working to lower barriers for patients – working with Turanga health to provide transport for those requesting it.
Using a SMS system (available within electronic medical system Medtech) to send encouraging messages.
Support through a facebook group.
Recipe books.
Handouts in addition to presentations.
Intervention code [1] 297334 0
Lifestyle
Intervention code [2] 297335 0
Behaviour
Comparator / control treatment
The control group will continue with their normal care, as provided through their General Practice.

At 4 months (unless with safety review at reveals the intervention is unsafe, ineffective, or of no benefit) the control group will be offered the intervention. The wait-list is also necessary because the facility where the intervention is held only has a physical capacity of 32 participants at a time.
Control group
Active

Outcomes
Primary outcome [1] 301294 0
Does the EDGE intervention, for patients with BMI greater than or equal to 30 AND type 2 diabetes mellitus OR pre diabetes, compared with usual treatment, result in a decrease in:
HbA1c?

HbA1c blood samples will be drawn and analysed at the local laboratory by technicians unaware of study allocation.
Timepoint [1] 301294 0
4 months from the start of the intervention (both groups)
12 months from the start of the intervention (intervention)
Primary outcome [2] 301295 0
Does the EDGE intervention, for patients with BMI greater than or equal to 30 AND type 2 diabetes mellitus OR pre diabetes, compared with usual treatment, result in a decrease in: BMI?

BMI will be measured by nurses at the Three Rivers Medical centre.
Timepoint [2] 301295 0
4 months from the start of the intervention (both groups)
12 months from the start of the intervention (intervention)
Secondary outcome [1] 332238 0
Does the EDGE intervention, for patients with BMI greater than or equal to 30 AND type 2 diabetes mellitus OR pre diabetes, compared with usual treatment, result in a decrease in: total or LDL cholesterol?

Cholesterol blood samples will be drawn and analysed at the local laboratory by technicians unaware of study allocation. Patients will be asked to fast prior to lipid testing, but samples will be analysed whether or not the sample was fasting.
Timepoint [1] 332238 0
4 months from the start of the intervention (both groups)
12 months from the start of the intervention (intervention)
Secondary outcome [2] 332242 0
Using the Big Five Inventory (BFI), are there personality traits associated with adherence to the EDGE intervention?
Timepoint [2] 332242 0
4 months from the start of the intervention (both groups)
12 months from the start of the intervention (intervention)

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Obesity (BMI equal or greater than 30 kg/m2).
2. T2DM or prediabetes (preference will be given to those with T2DM over pre diabetes).
3. Aged 18–70.
4. Patients enrolled in one medical practice: Three Rivers Medical, in Gisborne New Zealand.

Note: Diagnosis of diabetes for this research:
1. Established diagnosis of T2DM by a doctor on the electronic medical record based on blood sugar levels or HbA1c consistent with NZ guidelines.
2. HbA1c tested within six months of enrolment date, using NZ standard numbers:
a. Non diabetic less than or equal to 40 mmol/mol HbA1c
b. Prediabetes greater than or equal to 41 and less than or equal to 49 mmol/mol HbA1c
c. Diabetes greater than or equal to 50 mmol/mol HbA1c
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
a. Current use of insulin or injectable hypoglycaemic medication.
b. Current use of warfarin.
c. Life threatening co-morbidities.
d. Significant mental health disorders.
e. Current smoking.
f. Current alcohol or drug misuse (using NZ alcohol guidelines, or EMR records).
g. Currently pregnant or breastfeeding.
h. Conditions, medications or procedures which may directly affect weight (prior weight loss surgery, unmanaged thyroid disease, unstable medical disease, current use of medications promoting weight loss).
i. Current consumption of whole food plant based diet.
j. Unable or unwilling to participate in the group evening sessions.

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)
One researcher will generate a random 1:1 sequence and this will be passed to another off-site researcher to assign allocation in the order of interview to either intervention or wait-list control. Married, partnered, or otherwise related pairs will be randomised together.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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 and Analysis

We aim to have two groups of 24 participants. This is based on previous research results of our study team and assumes an 80% chance of demonstrating an effect with HbA1c at a confidence level of 95% (P < 0.05) with no type one or type two errors.

Results will be analsyed with using the pairwise deletion method. Within the intervention group we may allocate slightly different resources and analyse these subgroups (e.g. one subgroup of intervention received coloured vs uncoloured lecture materials). All t-tests will be two-tailed. Comparison of results between the two groups will be using an unpaired t-test, after performing an f-test to determine whether the groups of results have statistically significant variances.

Intention to treat

Because Gisborne is a small town, there is the possibility of contamination, whereby the wait-list control learns of and begins the dietary intervention. This will be assessed through a question (Did you make any other changes to your diet or exercise in the last four months? If so, what were these changes?) but does not preclude participation in the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2017
Actual
1/05/2017
Date of last participant enrolment
Anticipated
2/05/2017
Actual
22/05/2017
Date of last data collection
Anticipated
7/09/2018
Actual
22/08/2018
Sample size
Target
70
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 8698 0
New Zealand
State/province [1] 8698 0
Gisborne

Funding & Sponsors
Funding source category [1] 295769 0
Other
Name [1] 295769 0
Turanga Health
Country [1] 295769 0
New Zealand
Funding source category [2] 295770 0
Charities/Societies/Foundations
Name [2] 295770 0
Eastland Community Trust
Country [2] 295770 0
New Zealand
Primary sponsor type
Individual
Name
Dr Nicholas Wright
Address
Plant Based New Zealand Health Trust
PO Box 2064
Gisborne 4040
Country
New Zealand
Secondary sponsor category [1] 295046 0
None
Name [1] 295046 0
Address [1] 295046 0
Country [1] 295046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297068 0
New Zealand Southern Health and Disability Committee
Ethics committee address [1] 297068 0
Ethics committee country [1] 297068 0
New Zealand
Date submitted for ethics approval [1] 297068 0
22/03/2017
Approval date [1] 297068 0
24/03/2017
Ethics approval number [1] 297068 0
17/STH/47

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

Contacts
Principal investigator
Name 72866 0
Dr Nicholas Wright
Address 72866 0
Plant Based New Zealand Health Trust
PO Box 2064
Gisborne 4040
Country 72866 0
New Zealand
Phone 72866 0
+64 27 2727 285
Fax 72866 0
Email 72866 0
[email protected]
Contact person for public queries
Name 72867 0
Nicholas Wright
Address 72867 0
Plant Based New Zealand Health Trust
PO Box 2064
Gisborne 4040
Country 72867 0
New Zealand
Phone 72867 0
+64 27 2727 285
Fax 72867 0
Email 72867 0
[email protected]
Contact person for scientific queries
Name 72868 0
Nicholas Wright
Address 72868 0
Plant Based New Zealand Health Trust
PO Box 2064
Gisborne 4040
Country 72868 0
New Zealand
Phone 72868 0
+64 27 2727 285
Fax 72868 0
Email 72868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
A spreadsheet of all data
When will data be available (start and end dates)?
With publication (estimate early 2024). Dataset will be available with publication. Original data available on request for 5 years post study initiation.
Available to whom?
All, on request
Available for what types of analyses?
Any
How or where can data be obtained?
[email protected]


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.