Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial

Abstract

BackgroundWe have developed a healthy lifestyles programme (HeLP) for primary school aged children (9–10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.MethodsSchools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.ResultsAt baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0–13) energy dense snacks (EDS) and 3.23 (0–9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than ‘light’ intensity activity. Less than 5% of children achieved the Departments of Health’s recommendation of 60 min of MVPA every day.ConclusionWe have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.Trial registration ISRCTN15811706 (1/05/2012).

Are We Overestimating Physical Activity Prevalence in Children?

“…Full details of the HeLP trial are available elsewhere. 14,15 Prior to data collection, parents received an information sheet and an opt-out form. The Peninsula College of Medicine and Dentistry Ethics committee approved the trial in March 2012 (reference number 12/03/140).…”

Children’s Compliance With Wrist-Worn Accelerometry Within a Cluster-Randomized Controlled Trial: Findings From the Healthy Lifestyles Programme

“…Schools were then randomised to receive HeLP (5) or to the control arm (usual practice). Full details of recruitment and study procedures are provided elsewhere (5,14) (http://clahrc-peninsula.nihr.ac.uk/research/help-the-healthy-lifestyles-programme). Follow up PA data were collected 18 months post baseline, in June and 2015 for Cohorts 1 and 2, respectively.…”

“…Anthropometric data was collected in a private room by two trained and blinded assessors during a specifically designed lesson relating to measurement (14).…”

Comparative analysis of gross motor coordination between overweight/obese and eutrophic children

“…As for the influence of physical activity on motor development, it is widely known that overweight children may experience motor difficulties that limit their participation in physical activity [27]. This may cause children to prefer a sedentary life to an active life and is directly associated with impaired development of motor skills [19].…”