None listed
Conditions
Brief summary
The purpose of the study is to observe the effects of a community based programme that uses a plant-based diet with people with type II diabetes; observing both BMI and other clinical outcomes; what happens with the blood markers for diabetes; how the cholesterol and inflammation levels in their blood might be affected; changes with related anthropometric measures (including weight, waist circumference), and if medication usage changes.
Interventions
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 t
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.
Sponsors
Dr Nicholas Wright
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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.
Outcome results
None listed