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The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial

Katrina M Wyatt1*, Jennifer J Lloyd1, Charles Abraham1, Siobhan Creanor2, Sarah Dean1, Emma Densham6, Wendy Daurge7, Colin Green1, Melvyn Hillsdon3, Virginia Pearson5, Rod S Taylor1, Richard Tomlinson4 and Stuart Logan1

Author Affiliations

1 Institute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), Veysey Building, Salmon Pool Lane, Exeter, Devon EX2 4SG, UK

2 School of Computing and Mathematics, Faculty of Science and Technology, Room 301, Biostatistics, ITTC Building, Tamar Science Park, Plymouth, Devon PL6 8BX, UK

3 Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK

4 Royal Devon and Exeter Hospital, Royal Devon & Exeter NHS Trust, Department of Child Health Barrack Road, Exeter, EX2 5DW, UK

5 Directorate of Public Health, NHS Devon Commissioning Headquarters, County Hall, Topsham Road, Exeter, EX2 4QL, UK

6 Isca College, Earl Richards Rd, Exeter, Devon, EX2 6AP, UK

7 St Leonard's Primary School, St Leonards Rd, Exeter, Devon, EX2 4NQ, UK

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Trials 2013, 14:95  doi:10.1186/1745-6215-14-95

Published: 4 April 2013

Abstract

Background

Over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children.

Methods/Design

We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ≥19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme.

Discussion

The results of the trial will provide evidence on the effectiveness and cost effectiveness of the Healthy Lifestyles Programme in affecting the weight status of children.

Trial registration

ISRCTN15811706

Keywords:
Childhood obesity; School-based; Cluster trial; 9 to 10 year olds; Engagement; Parental involvement; Randomised controlled trial