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

Autor: Emma Densham, Siobhan Creanor, Katrina Wyatt, Charles Abraham, Richard Tomlinson, Virginia Pearson, Stuart Logan, Colin Green, Sarah Dean, Jennifer J Lloyd, Melvyn Hillsdon, Rod S Taylor, Wendy Daurge
Rok vydání: 2013
Předmět:
Research design
Time Factors
Cost effectiveness
Cost-Benefit Analysis
Health Behavior
Child Behavior
Medicine (miscellaneous)
Overweight
State Medicine
Body Mass Index
law.invention
Study Protocol
Intervention mapping
Clinical Protocols
Randomized controlled trial
law
Medicine
Pharmacology (medical)
Childhood obesity
Cluster randomised controlled trial
Child
Adiposity
Randomised controlled trial
Engagement
Behavior change methods
Health Care Costs
Treatment Outcome
England
Research Design
Cluster trial
Waist Circumference
medicine.symptom
School-based
Goals
Reinforcement
Psychology
medicine.medical_specialty
Health Promotion
Motor Activity
9 to 10 year olds
Humans
Parental involvement
Obesity
Exercise
School Health Services
business.industry
Feeding Behavior
medicine.disease
Diet
Physical therapy
business
Risk Reduction Behavior
Zdroj: Trials
ISSN: 1745-6215
Popis: 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
Databáze: OpenAIRE
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