The EDGe (End Diabetes Gisborne) trial. Using the whole-foods, plant-based diet in a community programme for people with obesity and diabetes

Not Applicable

Completed

• Conditions: Type II Diabetes; Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000541303
• Lead Sponsor: Dr Nicholas Wright

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Study Completion: 2018-08-22
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>HbA1c?<br><br>HbA1c blood samples will be drawn and analysed at the local laboratory by technicians unaware of study allocation.[ 4 months from the start of the intervention (both groups)<br>12 months from the start of the intervention (intervention)];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?<br><br>BMI will be measured by nurses at the Three Rivers Medical centre.[ 4 months from the start of the intervention (both groups)<br>12 months from the start of the intervention (intervention)]

Secondary Outcome Measures

Name	Time	Method
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?<br><br>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.[ 4 months from the start of the intervention (both groups)<br>12 months from the start of the intervention (intervention)];Using the Big Five Inventory (BFI), are there personality traits associated with adherence to the EDGE intervention?[ 4 months from the start of the intervention (both groups)<br>12 months from the start of the intervention (intervention)]