The PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for those with prediabetes (PROPELS) - Primary Care Unit

Title:	The PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for those with prediabetes
Principal research question:	Our goal is to find sustainable ways to increase physical activity among people who are at risk of developing type 2 diabetes in the future, in order to reduce this risk. The results will also be used by the government to help decide which physical activity promotion strategies to recommend in primary care.
Background:	This study aims to find out how we can help people at high risk of developing Type 2 diabetes to walk more. We hope that this will reduce their risk of getting diabetes and health problems in the future.
Methodology description:	The PROPELs study aims to recruit 1,300 men and women who have previously taken part in our research studies or have been identified from GP records as being eligible for the study. To be eligible individuals must have a blood glucose (sometimes referred to as blood sugar level) that is slightly raised but below the level at which diabetes is diagnosed. Eligible individuals will attend a local testing centre for a baseline health assessment and will then be randomised (allocated by chance) to one of three physical activity promotion groups (see below). Individuals will be 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 (http://www.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, we will compare physical activity levels in the three groups to try and identify the best method to promote and sustain increases in physical activity.
Sample group description:	Men and women aged 40-75 years old Those identified with impaired glucose regulation (IGR, sometimes referred to as ‘pre-diabetes’) in the last five years. Impaired glucose regulation means that the blood glucose (sometimes referred to as blood sugar) level is slightly raised but below the level at which diabetes is diagnosed. Individuals who are comfortable using a mobile phone to send and receive text messages.
Outcome measure description:	Primary outcome: change in ambulatory activity (steps per day measured using an accelerometer) at 48 months. Secondary outcomes: Physical activity measured by: Accelerometer data ActivPAL Recent Physical Activity Questionnaire (RPAQ) Biochemical variables: HbA1c Insulin, HOMA-B, HOMA-IR Urea & Electrolytes (U & E) Liver Function Tests (LFTs) Lipid profile (LDL, HDL & Triglycerides) Novel Biomarkers (Adiponectin, leptin, IL-6, hs-CRP) Vitamin C and D Urine sample Genetics Anthropometric and demographic measures: Height Body weight Body Mass Index (BMI) Body fat percentage Waist circumference Arm and leg length Blood pressure Medication status Smoking status Family history of disease 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) Depression Dietary questions (validated questions adapted from EPIC and Navigator) Sleep Health resources Neighbourhood Environmental Walkability Survey (NEWS)
Project organisation
Start date:	01 February 2012
End date:	01 February 2019
Contact person:	Gwen Brierley
Contact Details:	PROPELS Study Coordinator MRC Epidemiology Unit University of Cambridge School of Clinical Medicine Box 285 Institute of Metabolic Science Cambridge Biomedical Campus Cambridge CB2 0QQ Telephone: 0800 085 6183 E-mail: propels@mrc-epid.cam.ac.uk
Collaborative:	Professor Melanie Davies – University Hospitals of Leicester, Leicester Diabetes Centre; Dr Tom Yates, Dr Helen Eborall, Dr Laura Gray – University of Leicester; Professor Simon Griffin, Dr Rebecca Simmons – Medical Research Council (MRC) Epidemiology Unit, University of Cambridge; Dr Wendy Hardeman, Professor Stephen Sutton – University of Cambridge. See more project details on MRC Epidemiology website : http://www.mrc-epid.cam.ac.uk/research/studies/propels/
Funding Information
Funding organisation name:	NIHR HTA
Funding reference number:	09/162/02
Funding amount:	1,706,619