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