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Open Access Highly Accessed Study protocol

Living Well with Diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes

Elizabeth G Eakin1*, Marina M Reeves1, Alison L Marshall2, David W Dunstan13, Nicholas Graves2, Genevieve N Healy1, Jonathan Bleier1, Adrian G Barnett2, Trisha O'Moore-Sullivan4, Anthony Russell4 and Ken Wilkie5

Author Affiliations

1 The University of Queensland, Level 3 Public Health Building, School of Population Health, Cancer Prevention Research Centre, Herston Road, Herston, QLD, Australia

2 Queensland University of Technology, School of Public Health, Faculty of Health, Brisbane, Australia

3 Baker IDI Heart and Diabetes Institute, Melbourne, Australia

4 The University of Queensland, Centre for Diabetes and Endocrine Research, Princess Alexandra Hospital, Brisbane, Australia

5 Southeast Primary Healthcare Network, Logan, Australia

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BMC Public Health 2010, 10:452  doi:10.1186/1471-2458-10-452

Published: 3 August 2010

Abstract

Background

By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps.

Methods/Design

Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013.

Discussion

This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health behaviour change, and will build the evidence base needed to advocate for the translation of this work into population health practice.

Trial Registration

ACTRN12608000203358