Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 40-74 years or 25-74 years if South Asian 2. Diagnosed with Impaired Glucose Regulation (IGR) within the last 5 years
Exclusion criteria
Exclusion criteria: 1. Due to the nature of the intervention those unable to undertake ambulatory based activity will be excluded 2. Those diagnosed with diabetes 3. With screen detected diabetes at baseline 4. Pregnant women 6. Those with normal glycaemia with no previous record of IGR in the previous 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 12/07/2019: Change in ambulatory activity (steps/day) between baseline and 48 months, assessed by accelerometer (Actigraph GT3X+). Acceleration data are captured and stored at 100 Hz. Data processing will be undertaken on a commercially available analysis tool (KineSoft). Data will be integrated into 60-second epochs. At least 3 valid days of wear will be required, with a valid day defined as at least 10 hours of wear. Non-wear time will be determined by 1 hour or more of consecutive zero counts Previous primary outcome measure: Change in ambulatory activity (steps per day) at 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/07/2019: 1. Change in ambulatory activity (steps/day) between baseline and 12 months assessed by accelerometer (Actigraph GT3X+) 2. Assessed by accelerometer between baseline and 12 months, and between baseline and 48 months: 2.1 Number of censored steps/day (i.e. steps taken above an intensity used to distinguish between purposeful and incidental ambulation) 2.2 Time spent sedentary (mins) 2.3 Time spent in light physical activity (mins) 2.4 Time spent in moderate-to-vigorous physical activity (mins) 2.5 Compliance with recommendation to undertake at least 21.4 minutes/day (150 mins /week) of moderate-to-vigorous intensity physical activity in bouts of at least 10 minutes 2.6 Compliance with recommendation to undertake at least 21.4 minutes/day (150 mins/week) of moderate-to-vigorous intensity physical activity without bout restriction 3. Assessed by activPAL3 between baseline and 12 months, and between baseline and 48 months: 3.1 Time spent sitting or lying down (mins) 3.2 Time spent standing (mins) 3.3 Time spent walking (mins) 4. Assessed by Recent Physical Activity Questionnaire (RPAQ) between baseline and 12 months, and between baseline and 48 months: 4.1 Overall physical activity expenditure (kJ/day) 4.2 Time sedentary (mins), in light (mins), moderate-to-vigorous (mins) intensity physical activity 5. Main biochemistry outcomes between baseline and 12 months, and between baseline and 48 months: 5.1 HbA1c (mmol/mol) 5.2 HbA1c (%) 5.3 Total cholesterol (mmol/l) 5.4 HDL cholesterol (mmol/l) 5.5 LDL cholesterol (mmol/l) 5.6 Triglycerides (mmol/l) 5.7 Vitamin D (nmol/l) 6. Other biochemistry outcomes between baseline and 12 months, and between baseline and 48 months: 6.1 Sodium (mmol/l) 6.2 Potassium (mmol/l) 6.3 Urea (mmol/l) 6.4 Estimated glomerular filtration rate (eGFR; ml/min/1.73m2) 6.5 Total bilirubin (umol/l) 6.6 Alkaline phosphatase (IU/l) 6.7 Alanine transaminase (IU/l) 6.8 GGT (IU/l) 6.9 Urine albumin creatini | — |
Countries
England, United Kingdom