Lloyd Jenny, Creanor Siobhan, Price Lisa, Abraham Charles, Dean Sarah, Green Colin, Hillsdon Melvyn, Pearson Virginia, Taylor Rod S, Tomlinson Richard, Logan Stuart, Hurst Alison, Ryan Emma, Daurge Wendy, Wyatt Katrina
University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
Peninsula Clinical Trials Unit and Biostatistics, Bioinformatics & Biomarkers Group, Plymouth University Peninsula Schools of Medicine & Dentistry (formerly Peninsula College of Medicine and Dentistry), ITTC Building, Plymouth Science Park, Plymouth, Devon, PL6 8BX, UK.
BMC Public Health. 2017 Apr 4;17(1):291. doi: 10.1186/s12889-017-4196-9.
We 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.
Schools 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.
At 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.
We 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.
ISRCTN15811706 (1/05/2012).
我们为小学适龄儿童（9 - 10岁）制定了一项健康生活方式计划（HeLP），目前正在一项确定性整群随机对照试验中进行评估。本文按性别、整群水平社会经济地位、学校规模和纳入试验的时间，描述性地呈现了试验儿童的基线特征（体重指数、腰围、体脂百分比、饮食和身体活动）。
从英格兰西南部各地招募学校，并按符合免费学校餐（FSM，<19%，≥19%）条件的儿童比例和学校规模（一个五年级班级，>1个五年级班级）进行1:1分配，分为干预组（HeLP）或对照组（常规做法）。主要结局是随机分组后24个月时体重指数标准差评分（BMI sds）的变化。次要结局包括18个月时的BMI sds、18个月和24个月时的腰围和体脂百分比标准差、18个月和24个月时被分类为体重过轻、超重和肥胖的儿童比例、身体活动（针对一个子样本）以及18个月时的食物摄入量。
在基线时，分别有11.4%和13.6%的儿童被归类为超重或肥胖。超重或肥胖的女孩比例高于男孩（25.3%对24.8%），FSM类别2学校的儿童超重或肥胖比例更高（28.2%对23.2%）。儿童每天平均（范围）食用4.15（0 - 13）份高能量密度零食（EDS）和3.23（0 - 9）份健康零食（HS），FSM类别2学校的儿童食用更多的EDS和负面食物指标，更少的HS和正面食物指标。儿童每天平均花53.6分钟（11.9至124.8分钟）进行中等至剧烈强度身体活动（MVPA），每天花13小时（779.3分钟）（11小时至15小时）进行低于“轻度”强度的活动。不到5%的儿童达到了卫生部每天60分钟MVPA的建议。
我们所有测量指标的基线数据完整性极佳，并且在加速度计测量方面实现了其他大规模研究中未见的依从性。我们的人体测量基线数据代表了该年龄段儿童的当地和全国数据，并反映了该年龄段儿童在身体活动和体重状况方面预期的性别和社会经济差异。
ISRCTN15811706（2012年5月1日）。
