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Open Access Research

Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

Edward D Janus12, James D Best3, Nathalie Davis-Lameloise1, Benjamin Philpot1, Andrea Hernan1, Catherine M Bennett4, Sharleen O’Reilly4, Rob Carter5, Erkki Vartiainen6, James A Dunbar1* and on behalf of the Melbourne Diabetes Prevention Study research group

Author Affiliations

1 Greater Green Triangle University Department of Rural Health, Flinders University and Deakin University, PO Box 423, Warrnambool, VIC, 3280, Australia

2 Department of Medicine, North West Academic Centre, The University of Melbourne, Western Hospital, Footscray, VIC, 3011, Australia

3 Melbourne Medical School, The University of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia

4 Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia

5 Deakin Health Economics, Deakin Strategic Research Centre – Population Health, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia

6 National Institute for Health and Welfare, Mannerheimintie 166, 00300, Helsinki, Finland

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Trials 2012, 13:152  doi:10.1186/1745-6215-13-152

Published: 28 August 2012

Abstract

Background

The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation.

Methods

The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance.

Results

Intervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE) = 0.26), weight (−2.65 kg, SE = 0.72), waist circumference (−7.45 cm, SE = 1.15), and systolic blood pressure (−3.18 mmHg, SE = 1.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03), reduced energy from total (−2.00%, SE = 0.78) and saturated fat (−1.54%, SE = 0.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27). Only waist circumference reduced significantly (−4.02 cm, SE = 0.95).

Intervention participants significantly outperformed controls over 12 months for body mass index and fibre intake. After baseline adjustment, they also showed greater weight loss and reduced saturated fat versus total energy intake.

At least 5% weight loss was achieved by 32% of intervention participants versus 0% controls.

Conclusions

pMDPS results indicate that scaling-up from implementation trial to state-wide programme is possible. The system design for Life! was fit for purpose of scaling-up from efficacy to effectiveness.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12609000507280

Keywords:
Type 2 diabetes; Prevention; Lifestyle; Intervention; Implementation; Randomised controlled trial; Effectiveness