Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a diagnosis of T2D for >1 year and 7 and <11 4. Patients who commit to attend all of the programme and data collection sessions 5. Patients who are able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who are currently pregnant 2. Patients who cannot read and write in English 3. Patients who are not capable of moderate physical activity 4. Patients who have participated in a research study investigating medical products in the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate whether the Steps 12-month education programme delivered to a population with established T2D (>12 months <10 years duration) can yield a reduction in HbA1c levels of = 0.6%, which represents a clinically significant change in glycaemic control, at 12 months post-baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate whether the Steps 12-month education programme delivered to a population with established T2D (>12 months <10 years duration) can yield improvements in biomedical measures (to include Cholesterol (Total, HDL, LDL), Blood Pressure, BMI, Weight, Waist, hip and neck circumference), psychosocial measures (to include Learning style preference, Quality of life , Diabetes-related distress, Depression presence and severity, Diabetes self efficacy, Diabetes knowledge , Perceived social support, Readiness to change), and lifestyle outcome measures (to include Smoking status, Alcohol intake, Physical activity, Dietary intake) at 3, 6 and 12 months post baseline session. | — |
Countries
United Kingdom