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. 2017 Dec 4;2017(12):CD003054. doi: 10.1002/14651858.CD003054.pub4

PROPELS.

Trial name or title Acronym: PROPELS
Methods Type of study: efficacy study
Allocation: randomised
Intervention model: parallel assignment
Masking: open‐label
Primary purpose: prevention
Participants Condition: intermediate hyperglycaemia
Enrollment: 1308
Inclusion criteria: 40–74 years old for white European, or aged 25–74 years old for South Asian; previously recorded plasma glucose or HbA1c value in the prediabetes range within the last
 5 years; have access to a mobile phone, and willing to use it as part of the study
Exclusion criteria: due to the nature of the intervention those unable to undertake ambulatory‐based activity will be excluded; T2DM; screen‐detected diabetes at baseline; pregnancy; normoglycaemia with no previous record of intermediate hyperglycaemia in the previous 5 years
Interventions Intervention(s): diet as the comparator group, but additional physical activity provided
Comparator(s): receive a booklet detailing information on risk factors for T2DM and cardiovascular disease and how physical activity can be used to prevent T2DM and cardiovascular disease.
Duration of the intervention: 48 months
Outcomes Primary outcome(s): change in ambulatory activity
Secondary outcome(s): time spent in sedentary, light, moderate and vigorous intensity physical activity assessed by accelerometer and self report; website use and text messages sent/received (intervention group 3 only); fasting and 2‐h post‐challenge glucose and HbA1c; fasting lipid profile, fasting insulin, highly sensitive C‐reactive protein, key adipokines (interleukin 6 and tumour necrosis factor alpha), urea and electrolytes (sodium, potassium, urea, creatinine) and liver function tests; markers of chronic inflammation and adipokines; vitamin C and D; genetic analysis; urine sample; height; body weight; BMI; body fat percentage; waist circumference; arm and leg length; blood pressure; medication status; smoking status; family history of disease; muscular/skeletal injury; illness perceptions; self efficacy; self regulation; quality of life; depression and anxiety; diet; sleep; body composition
Other outcome(s):‐
Starting date Study start date: August 2013
Study completion date: August 2018
Contact information Responsible party/principal investigator: University of Leicester, UK
Study identifier ISRCTN: 83465245
Official title The PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for those with pre‐diabetes
Stated purpose of study Quote: "Can an intervention to support physical activity behaviour change lead to sustained increases in physical activity over four years in those with a high risk of type 2 diabetes."
Notes

BMI: body mass index; HbA1c: glycosylated haemoglobin A1c; IFG: impaired fasting glucose; IGT: impaired glucose tolerance; T1DM: type 1 diabetes mellitus; T2DM: type 2 diabetes mellitus