Specialty: Primary care, Primary sub-specialty: Diabetes
Conditions
Interventions
Participants are randomly allocated in a 2:1 intervention:control ratio, using permuted block design randomisation, and allocation stratified by practice.
Control group:
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. BMI of =30kg/m2 4. Diagnosed with type 2 diabetes 5. Patients must have undergone diabetic retinopathy screening within the last 12 months
Exclusion criteria
Exclusion criteria: 1. History of, or features suspicious of, an eating disorder 2. Pregnant, breastfeeding, currently undergoing fertility treatment, or planning to become pregnant during the course of the study 3. Recent MI or CVA (<3 months) 4. Uncontrolled ischaemic heart disease, critical ischaemia, uncontrolled hypertension, uncontrolled cardiac arrhythmia (eg inadequate rate control in AF, inadequate episode control paroxysmal AF), cardiac conduction abnormality (eg long QT syndrome) 5. Cardiac failure (Grade II New York Heart Association, and more severe) 6. Renal failure (CKD Stage 4 or 5) 7. Active treatment for cancer (other than skin cancer treated with curative intent by local treatment only) 8. Intercurrent serious infection at time of recruitment 9. Diagnosed with a significant psychiatric disorder or substance abuse 10. Serious neurological disorder, including epilepsy 11. Recently undergone significant surgery (<6 months) 12. History of bariatric surgery, including gastric banding 13. Are currently using a “fasting”/low-energy diet 14. Unwilling to consider any dietary changes 15. Unable to understand English 16. Are currently using insulin therapy, or SGLT2 inhibitors (Glifozins – e.g. empaglifozin, dapaglifozin, canaglifozin) 17. Non-proliferative retinopathy level R2 or worse (ie, any level more severe than “background” non-proliferative diabetic retinopathy, R1), proliferative diabetic retinopathy, or maculopathy 18. HbA1c = 93mmol/mol (10.5%) 19. Recruiting physician feels they are inappropriate for recruitment due to any other reason NB: If the patient is taking warfarin, they are not excluded from participating in the study, but will be advised to inform their local monitoring service about their participation, and they may be advised to have additional blood test monitoring of their INR as part of their care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the behavioural and dietary intervention, delivered in primary care, aiming to promote weight loss and improved glycaemic control, and whether to progress to a full-scale RCT. The measures of feasibility are: 1. The proportion of allocated intervention group participants who attempt the dietary intervention after randomisation, assessed through nurse documentation at intervention visit 2. Fidelity of intervention delivery: the proportion of essential elements included in intervention delivery sessions; evaluation of transcribed audio-recordings following intervention delivery visits, assessed against a checklist of essential elements 3. The proportion of enrolled participants who attend the final follow-up session, assessed at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/03/2021: Process measures: 1. Percentage of eligible patients as a proportion of total practice population of patients with type 2 diabetes, assessed through trial data collected from practices at baseline 2. Proportion of patients who enrol in the study with “poor control” (HbA1c above the NICE target of =7% (53mmol/mol), trial data collected at baseline visit 3. Percentage of people who fulfil the recruitment criteria who accept the invitation to participate, assessed through number of invitations sent and number of contacts to the study team at baseline 4. Participant adherence to the protocol, assessed via self-reported concordance at 2, 4, 8 and 12 weeks, and 24 hour dietary recall questionnaire at 2, 8 and 12 weeks 5. Contamination of control group (who choose to follow the principles of the dietary intervention, despite being allocated to the control group), assessed via 24-hour dietary recall questionnaires at baseline and 12 weeks Effectiveness measures: 1. Change in HbA1C (including change in number of patients classified as having an HbA1c in the “diabetic”, “at risk of diabetes”, or “diabetes in remission” range), assessed via HbA1c blood test at baseline, 8 and 12 weeks 2. Change in fasting glucose and fasting insulin, converted into HOMA-B and HOMA-S, via blood test at baseline, 8 and 12 weeks 3. Change in weight, measured using a calibrated electronic scale at baseline and 12 weeks 4. Change in diabetic medication (number and dose of diabetic medications; initiation of new medication during study period; initiation of insulin; initiation of injectable diabetic medication), assessed via nurse reporting at 2, 4, 8 and 12 weeks 5. Change in lipid profile, blood test measured at baseline and 12 weeks 6. Cha | — |
Countries
England, United Kingdom
Outcome results
None listed