PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes PROPELS: study protocol for a randomized controlled trialReport as inadecuate




PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes PROPELS: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 16:289

First Online: 02 July 2015Received: 03 March 2015Accepted: 18 June 2015DOI: 10.1186-s13063-015-0813-z

Cite this article as: Yates, T., Griffin, S., Bodicoat, D.H. et al. Trials 2015 16: 289. doi:10.1186-s13063-015-0813-z

Abstract

BackgroundThe prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes.

Methods-DesignA multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40–74 years for White European, or 25–74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4 % 42 and 47 mmol-mol or with a previously recorded plasma glucose level or HbA1c value within the high risk prediabetes range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants.

Participants are randomly assigned to either: 1 the control group who receive a detailed advice leaflet; 2 the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3 the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.

DiscussionThis study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention.

Trial registrationISRCTN83465245 Trial registration date: 14-06-2012

KeywordsPrevention Impaired glucose regulation Type 2 diabetes Prediabetes Walking Physical activity Pedometer Structured education Primary care Randomised controlled trial mHealth AbbreviationsBIPQBrief illness perceptions questionnaire

DESMONDDiabetes Education and Self-Management for Ongoing and Newly Diagnosed

DMECData Monitoring and Ethics Committee

EPICEuropean Prospective Investigation of Cancer and Nutrition

EQ-5DEuropean Quality of Life-5 Dimensions

HbA1cGlycated haemoglobin

prediabetesImpaired glucose regulation

NAVIGATORNateglinideAnd Valsartan in Impaired Glucose Tolerance Outcomes Research

NICENational Institute of Health and Care Excellence

OGTTOral glucose tolerance test

PAPhysical activity

QALYQuality adjusted life years

PREPAREPrediabetes Risk Education and Physical Activity Recommendation and Education

PROPELSThe PRomotionOf Physical activity through structured Education with differing Levels of ongoing Support for those with prediabetes

SF-8Short form 8

T2DMType 2 Diabetes Mellitus

TSCTrial steering committee

WHOWorld Health Organization

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Author: Tom Yates - Simon Griffin - Danielle H Bodicoat - Gwen Brierly - Helen Dallosso - Melanie J Davies - Helen Eborall - Char

Source: https://link.springer.com/







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