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Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

Lucy Yardley1*, Lisa J Ware2, Emily R Smith1, Sarah Williams3, Katherine J Bradbury1, Emily J Arden-Close1, Mark A Mullee4, Michael V Moore5, Janet L Peacock6, Mike EJ Lean7, Barrie M Margetts5, Chris D Byrne8, Richard FD Hobbs9 and Paul Little5

Author Affiliations

1 Centre for Applications of Health Psychology (CAHP), Faculty of Social and Human Sciences, University of Southampton, Southampton, UK

2 Hypertension in Africa Research Team (HART), North-West University, Mahikeng, South Africa

3 Psychology Research Centre, Faculty of Science and Technology, Bournemouth University, Bournemouth, UK

4 NIHR Research Design Service South Central, Faculty of Medicine, University of Southampton, Southampton, UK

5 Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK

6 Division of Health and Social Care Research, King’s College London; NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King's College London, London, UK

7 Human Nutrition, School of Medicine, University of Glasgow, Glasgow, UK

8 Southampton National Institute for Health Research (NIHR) Biomedical Research Centre, University Hospital Southampton and University of Southampton, Southampton, UK

9 Nuffield Department of Primary Care Health Sciences, Faculty of Medicine, University of Oxford, NIHR SPCR, NIHR Oxford BRC, and NIHR Oxford CLAHRC, Oxford, UK

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International Journal of Behavioral Nutrition and Physical Activity 2014, 11:67  doi:10.1186/1479-5868-11-67

Published: 21 May 2014

Abstract

Background

There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial.

Methods

This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures.

Results

All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients.

Conclusions

This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context.

Trial registration

Current Controlled Trials ISRCTN31685626.

Keywords:
Weight reduction programme; Internet; Randomized controlled trial; Obesity; Nurse support