HeLP – the Healthy Lifestyles Programme

Read a BITE sized summary of this project.

Background

The proportion of children who are obese has doubled in England in the last ten years and currently one third of 10-11 year olds are overweight or obese. Childhood obesity is associated with health issues in childhood, as well as reduced self-esteem and quality of life; however, there is still a paucity of evidence for effective interventions that engage children and parents to make and sustain lifestyle behaviour change. The Healthy Lifestyles Programme is an innovative school located intervention,developed using behaviour change theory and extensive stakeholder involvement, that seeks to deliver healthy lifestyle messages to encourage children to seek their parents support and effect change within the family.

Key to engagement are the interactive drama activities which have been developed in collaboration with Headbangers Theatre Company. Behavioural and weight status outcomes 18 and 24 months from the exploratory trial of the Programme showed consistency in the direction of effects, all in favour of HeLP, demonstrating ‘proof of concept’. These results provided sufficient evidence for the team to secure £1.35million funding from the NIHR Public Health Programme to determine the effectiveness of HeLP with circa 1,300 9-10 year olds from 32 schools across Devon and Plymouth. Half of the schools have been randomly selected to receive the Programme and these will be compared with the 16 schools with no intervention.

This is a cluster randomised controlled trial, economic and process evaluation to determine the effectiveness and cost effectiveness of HeLP. It is funded by the NIHR Public Health Research Programme.

Objectives

1. To assess the effectiveness of the Healthy Lifestyles Programme (HeLP), in children aged 9-10 years, by comparing in intervention and control schools (adjusting for baseline measures):

Body Mass Index (BMI) standard deviation scores (SDS) at 24 months (primary outcome) and 18 months
Waist Circumference SDS at 18 and 24 months
% Body Fat SDS at 18 and 24 months
Proportion of children classified as underweight, overweight and obese at 18 and 24 months
Physical activity (average time spent per day in sedentary, light, moderate, vigorous and total physical activity) at 18 months
Food intake at 18 months

2. To assess the costs of HeLP and cost-effectiveness versus usual practice

3. To conduct a mixed-methods process evaluation and mediational analysis to provide insight into the way the Programme worked (delivery, uptake, how it was experienced and what the behavioural mediators of change are).

Update

The study started in March 2012 and 32 schools were recruited. Sixteen schools entered the study in September 2012 (cohort 1) and baseline measures were taken on 655/658 (99.5%) of children from all 16 schools. Eight schools were randomised to receive HeLP, with eight schools acting as controls. Delivery of the intervention in the 8 Programme schools in cohort 1 was completed in November 2013. Immediately following the end of the intervention, the 12 month measure (My Lifestyle Questionnaire) was collected on 630/658 (96%) of the children. In May/June 2014, 18 month measures were taken on 626/658 (95%) of children. All children were then tracked to their secondary school and in Oct/Nov 2014, 24 month measures were taken from 616/658 (94%) of children. The total number of children lost to follow up in cohort 1 is 37 (96%).

The second set of 16 schools (cohort 2) entered the study in September 2013 and baseline measures were taken on 657/666 (98.6%) of children from all 16 schools. The eight schools in this cohort that had been randomised to receive HeLP or act as controls were revealed to the trial team following baseline measures. Delivery of the intervention in the 8 cohort 2 schools was completed in Nov 2014. Immediately following the end of the intervention, the 12 month measure (My Lifestyle Questionnaire) was collected on 647/666 (97%) of the children. 18 month measures will be taken in May/June 2015. To date the loss to follow up in cohort 2 is 13 children (1.2%).

The trial of the Healthy Lifestyles Programme has now come to an end and the team is in the process of analysing all of the data and writing up the results. The results have been shared with the schools, children and families involved in the trial and, once the team has officially released the results, a summary and a link to the document will be available here.

For more information of this trial please visit the NIHR PHR website.

HeLP was included as a case study in the 2014/15 PenCLAHRC Annual Report. You can download a copy from the right-hand sidebar.

Below is a video of the HeLP programme in action: