Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Prediabetes based on FPG 5.6–6.9 mmol/L and/or HbA1c 5.7–6.4% (39–47 mmol/mol) 2. No previous diagnosis of Type 2 diabetes 3. Age = 18 years – 75 years 4. BMI = 25 5. Weight stable for the past 6 months 6. Access to a computer, internet and smart mobile phone 7. Happy and able to use a smart mobile phone 8. Willing and able to provide written informed consent 9. Willing to wear the activity monitor for 7 days 10. Willing to undertake study activities including the BODPOD
Exclusion criteria
Exclusion criteria: 1. Inability to speak or read English 2. Insulin treated 3. Contraindications to exercise determined at the exercise screening 4. Contraindications to weight loss 5. Mental or physical incapacity which makes self management inappropriate 6. Pregnancy, planning pregnancy, or lactating 7. Unable to meaningfully participate for the full duration of the study 8. Participated in a research study within the last 6 months 9. Have any allergies which are related to any of the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The feasibility of recruitment, including length of time required to complete patient recruitment and retention rates, monitored throughout the study through screening and recruitment records and follow-up contact with patients. 2. Adherence to and completion of the intervention, assessed through focus groups and individual interviews at the end of the intervention 3. Delivery of intervention components by lifestyle coaches (i.e. in accordance to the protocol), assessed through focus groups and individual interviews at the end of the intervention 4. Enabling factors and barriers to completion of the programme and effective implementation, assessed through focus groups and individual interviews at the end of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body composition measured using BODPOD at months 0, 3 and 9 2. Metabolic control measured using fasting blood samples at months 0, 3 and 9 3. Fitness assessed using cardiopulmonary exercise testing at months 0, 3 and 9 4. Cardiac function measured using non-invasive cardiac output monitoring at months 0, 3 and 9 | — |
Countries
United Kingdom