The PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for those with pre-diabetes (PROPELS)

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

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 creatinine ratio (mg/mmol)
7. Cardiovascular risk between baseline and 12 months, and between baseline and 48 months:
7.1 Modelled cardiovascular risk based on the Framingham risk equation (D’Agostino 2008) (%)
8. Anthropometry between baseline and 12 months, and between baseline and 48 months:
8.1 Weight (kg)
8.2 BMI (kg/m2)
8.3 Waist circumference (cm)
8.4 Body fat percentage (%)
8.5 Fat mass (kg)
8.6 Fat free mass (kg)
9. Depression and anxiety measured using the HADS, between baseline and 12 months, and between baseline and 48 months:
9.1 Depression score
9.2 Anxiety score
10. Diet measured by self-report, between baseline and 12 months, and between baseline and 48 months:
10.1 Frequency (portions/week) of fresh fruit, green leafy vegetables, other vegetables, oily fish, other fish, chicken, meat, eggs, cheese, wholemeal/brown bread.
10.2 Alcohol: Frequency (drinks/day)
10.3 Number of days/week on which individual reported limiting total fat intake
10.4 Number of days/week on which individual reported limiting saturated fat intake
10.5 Number of days/week on which individual reported limiting sugar intake
10.6 Number of days/week on which individual reported limiting salt intake
11. Sleep measured using self-report between baseline and 12 months, and between baseline and 48 months:
11.1 Time spent asleep last night (hrs)
11.2 Average sleep duration (hrs/night)
12. Health-related quality of life between baseline and 12 months, and between baseline and 48 months:
12.1 Summary mental and physical component scores from SF-8
12.2 Summary index from EQ-5D-5L
12.3 Self-related health based on the Visual Analogue Scale questionnaire
13. Diabetes (yes/no) at 12 months and 48 months
14. Intermediate outcomes
Change in theoretical behavioural constructs hypothesised to be determinants of behaviour change will be considered “intermediate outcomes” and assessed between baseline and 12 months, and between baseline and 48 months.
14.1 Walking self-efficacy measured using confidence (0-100%) to walk for a short (10 minutes), moderate (30 minutes) and long (60 minutes) duration each day
14.2 Illness perception measure using scores (0-10) for each item of the illness perception questionnaire:
14.2.1 How much does your risk of diabetes affect your life?
14.2.2 How long do you think your risk of diabetes will continue?
14.2.3 How much control do you feel you have over your risk of diabetes?
14.2.4 How much do you think treatment can help your risk of diabetes?
14.2.5 How much do you experience symptoms from your risk of diabetes?
14.2.6 How concerned are you about your risk of diabetes?
14.2.7 How well do you feel you understand your risk of diabetes?
14.2.8 How much does your risk of diabetes affect you emotionally? (e.g. does it make you angry, scared, upset or depressed?)
14.3 Self-regulation measured using categorical responses (most of the time, some of the time, rarely, never) for self-regulation items (assessed at 12 and 48 month follow-up only):
14.3.1 Set yourself regular goals detailing the amount of exercise you would do each day
14.3.2 Regularly set yourself a plan detailing where, when and how you would exercise
14.3.3 Worn a pedometer
14.3.4 Kept an exercise log recording your activity levels
14.3.5 Been aware of your activity levels
14.3.6 Tried to exercise regularly


Previous secondary outcome measures:
1. Time spent in sedentary, light, moderate and vigorous intensity physical activity assessed by accelerometer and selfreport (RPAQ)
2. Website use and text messages sent/received (intervention group 3 only)
3. Fasting and 2hour postchallenge glucose and HbA1c
4. Fasting lipid profile, fasting insulin, highly sensitive C-reactive protein, key adipokines (interleukin 6 and tumour necrosis factor alpha), urea & electrolytes (sodium, potassium, urea, creatinine) and liver function tests (Albumin, Total Bilirubin, Alkaline Phosphatase (ALP), Alanine Transaminase (ALT))
5. Markers of chronic inflammation and adipokines [Adiponectin, leptin, IL6, high sensitivity C-reactive protein (hsCRP)]
6. Vitamin C & D
7. Genetic analysis
8. Urine sample
9. Height
10. Body weight
11. Body Mass Index (BMI)
12. Body fat percentage
13. Waist circumference
14. Arm and leg length
15. Blood pressure
16. Medication status
17. Smoking status
18. Family history of disease
19. Muscular/skeletal injury
20. Illness perceptions
21. Selfefficacy
22. Self regulation
23. Quality of life
24. Depression and anxiety
25. Diet
26. Sleep
27. Body composition [Dual-energy X-ray absorptiometry (DEXA) & Magnetic resonance imaging (MRI)]