• Rationale
• Aims of the study
• Design
• Chief/Principal investigators
• Co-investigators
• Status
• Unit role
• Sponsors
• Partners and stakeholders
• Funding
• Data sharing
• Trial Registration Number

Rationale

Type 2 diabetes (an inability to adequately regulate blood glucose levels) is a chronic condition that affects over 4.2 million people in the United Kingdom. This number is predicted to rise to 5 million by 2030. In between having normal blood glucose levels and having type 2 diabetes there exists a state in which blood glucose levels are raised above the normal range but do not meet the diagnostic criteria for type 2 diabetes; this has been called impaired glucose regulation (IGR). People with IGR are at increased risk of developing diabetes. Research suggests that type 2 diabetes can be prevented or delayed in people with IGR through changes in lifestyle such as increasing physical activity, changing diet and losing weight. PROPELS is evaluating the effectiveness of an intervention to support people with IGR to achieve sustained increases in physical activity over four years.

Aims of the study:

The PROPELS study recruited 1,368 middle-aged men and women who had previously taken part in our research studies or had been identified from GP records as being eligible for the study. To be eligible individuals must have had impaired glucose regulation within the previous 5 years.

Eligible individuals attended a local testing center for a baseline health assessment and were then randomised (allocated by chance) to one of three groups (see below). Individuals have been followed up after one and four years for a health and physical activity assessment.

Group 1: Detailed advice leaflet

Group 2: The same intervention as Group 1 plus

• the DESMOND (desmond-project.org.uk) “Walking Away from Diabetes” Programme  plus a follow-up refresher 2.5 hr. session every year until end of study in four years

Group 3: The same intervention as group 2 plus

• ongoing text message support to promote physical activity; participants will receive one text message a week for six months after the initial DESMOND session and once a month after this until the end of the study
• brief support telephone calls by trained educators, one week and six months after attending the DESMOND session

At the end of the study, physical activity levels are being compared in the three groups to try and identify the best method to promote and sustain increases in physical activity.

Design:

PROPELS is a multicentre (Leicester and Cambridge) randomised controlled trial to compare three different modes of physical activity intervention with control conditions.

Primary outcome

The primary outcome is change in ambulatory activity (steps per day) at 48 months assessed by an accelerometer (similar to a step counter) worn on a belt around the waist.

Secondary outcomes

Physical activity:

• Accelerometer data
• ActivPAL (measures time spent lying, standing, sitting)
• Recent Physical Activity Questionnaire (RPAQ)

Biochemical variables:

• Fasting and 2-hour glucose (Oral Glucose Tolerance Test)
  • Leicester site only
• HbA_1c (glycated haemoglobin, a measure of the average blood glucose over the preceding 10 weeks)
• Diagnosis of type 2 diabetes
• Insulin,
• Urea & Electrolytes (kidney function)
• Liver Function Tests
• Lipid profile (LDL and HDL cholesterol & triglycerides)
• Novel Biomarkers (Adiponectin, leptin, IL-6, hs-CRP)
• Vitamin C and D
• Urine sample
• Genetics

Anthropometric and clinical measures:

• Body weight
• Body Mass Index (BMI: weight in kilograms divided by height in metres squared)
• Body fat percentage
• Waist circumference
• Blood pressure
• Medication status
• Smoking status
• Muscular/skeletal injury

Psychological variables and other questionnaire data:

• Illness perceptions (Brief Illness Perceptions Questionnaire)
• Self-efficacy
• Self-regulation
• Health utility (EQ-5D); Short Form-8 (SF-8)
• Anxiety and Depression (HADS)
• Dietary questions
• Sleep duration
• Health service use

Chief/Principal investigators

Chief Investigator: Professor Kamlesh Khunti – University of Leicester

Principal Investigator (Cambridge): Professor Simon Griffin – University of Cambridge

Co-Investigators

Professor Melanie Davies – University of Leicester

Professor Tom Yates – University of Leicester

Dr Wendy Hardeman – University of East Anglia

Professor Stephen Sutton – University of Cambridge

Dr Helen Eborall – University of Leicester

Professor  Laura Gray – University of Leicester

Dr Danielle Bodicoat – University of Leicester

Mike Gillett – University of Sheffield

Mubarak Patel – University of Warwick (was Leicester Diabetes Centre)

Status

Completed.

Unit role

The MRC Epidemiology Unit, School of Clinical Medicine, University of Cambridge are co-investigators and act as a recruiting centre.

Sponsors

University of Leicester.

Partners and Stakeholders

University of Cambridge, University of East Anglia, University of Sheffield

Funding

PROPELS is funded by the National Institute for Health Research’s HTA Programme.

Data sharing

Please see our Data Sharing pages for more information.

Trial Registration Number

This study was prospectively registered (ISRCTN83465245). Registered 22 May 2012 http://www.isrctn.com/ISRCTN83465245.