Overweight and obesity, type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI =25kg/m2 2. Age =18 years 3. Diagnosis of type 2 diabetes within previous 36 months 4. Capable of giving informed consent 5. Have a good understanding of the English language (study materials are not tailored to support non-English language speakers) 6. Willing to be randomised 7. Willing to attend follow up visits at a local participating GP practice
Exclusion criteria
Exclusion criteria: 1. Using insulin 2. Previous/planned bariatric surgery 3. Current/planned pregnancy 4. Current diagnosis of eating disorder 5. Already received a structured diabetes education programme 6. GP considers unsuitable 7. Participation in another structured behaviour change programme for diet and/or physical activity within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 month change from baseline in HbA1c, adjusted for baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 6 month change from baseline in HbA1c, adjusted for baseline 2. 6 and 12 month changes from baseline, adjusted for baseline, in body weight, body fat percentage, systolic and diastolic blood pressure, total cholesterol, HDL cholesterol, and LDL cholesterol 3. Probability of achieving good glycaemic control (HbA1c <53 mmol/mol) at 6 and 12 months 4. Probability of achieving remission (HbA1c <48 mmol/mol and without medication for =2 months) at 6 and 12 months 5. Probability of losing =5% and =10% of initial body weight at 6 and 12 months 6. Modelled cardiovascular risk (UKPDS) at 12 months | — |
Countries
England, United Kingdom