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临床试验/NCT02963805
NCT02963805已完成不适用

Active City of Liverpool Active Schools and SportsLinx Project: a Clustered Randomised Controlled Trial (The A-CLASS Project)

Liverpool John Moores University0 个研究点目标入组 152 人开始时间: 2006年9月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
主要终点
Change from baseline in total skills score at end intervention (9 months) and follow up (3 years)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the A-CLASS project was to measure the effect of the 4 hour offer on children's physical activity, health and physical competence.

详细描述

Study design

Treatment arms in this four-arm parallel-group cluster randomised controlled trial (RCT) included a high intensity physical activity (HIPA) intervention group, a fundamental movement skill (FMS) intervention group, a physical activity signposting (PASS) intervention group and a control group (usual practice).

Recruitment

  • Organisation level

Sixteen primary schools were targeted by the research team in May-July 2006. The schools were targeted based on their size (student enrolment >400 primary school; >250 junior school), current afterschool club provision (limited), school sport facilities available for use (bi-weekly) and socioeconomic status of the school postcode classified by postcode in the Index of Multiple Deprivation as deprived (IMD > 40). Signed consent was sought and obtained from the head teachers of the sixteen schools for pupil recruitment, study contact, laboratory visits during school time and access to school facilities. Eight from the sixteen schools were randomly selected to take part using random number allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
9 Years 至 10 Years（Child）
性别
All
接受健康志愿者
是

入选标准

  • •a. body mass index (BMI) score within the lower 50th percentile relative to children in their year at their school.

排除标准

  • •family history of sudden death.
  • •presence of chronic disease, metabolic disorders, motor or co-ordination difficulties
  • •prescribed medications including steroids inhaled by asthma sufferers

结局指标

主要结局

Change from baseline in total skills score at end intervention (9 months) and follow up (3 years)

时间窗: Baseline (month 0), End-intervention (9 months), Follow-up (3 years)

8 fundamental movement skills were assessed (vertical jump, sprint run, hop, dodge (locomotor) kick, catch, overarm throw, strike (object-control). Assessments were conducted in the school playground or gym (weather dependent) by one researcher with the same equipment at each site. Children were given a verbal description and single demonstration of the skill. Children performed each skill 5 times (3 for the sprint run and dodge) in a standardised order. Recordings of all participants were taken from identical angles and distances using a tripod mounted video camera. Skills were assessed by video analysis using process-orientated measures. If the skill component was present on 4 out of 5 trials (2 out of 3 for sprint run and dodge) the child was marked as possessing that skill component. The number of skill components checked as present in each of the 8 skills was summed to create an overall skill score (max score 48) for use in the analysis.

次要结局

  • Change from baseline in bone areal density of the total body at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone areal density of the lumbar spine at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in fat mass at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in body mass index at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone mineral content of the femoral neck at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone areal density of the femoral neck at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone mineral content of the total body at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone mineral content of the lumbar spine at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in lean tissue mass at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in percentage body fat at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in visceral fat at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in triceps skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in subscapular skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the strike at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in systolic blood pressure at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in steps taken at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in biceps skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in abdomen skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the kick at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in left ventricular structures at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in iliac crest skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in supraspinale skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in front thigh skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in medial calf skinfold thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in arm girth relaxed at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone breadth on the biepicondyles of the humerus at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the sprint run at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the overarm throw at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in diastolic blood pressure at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in left ventricular mass at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in carotid artery intima media thickness at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in peak oxygen uptake at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in light intensity physical activity at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in moderate intensity physical activity at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in waist circumference at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in gluteal circumference at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in arm girth flexed and tensed at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in calf girth at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in bone breadth on the biepicondyles of the femur at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the vertical jump at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the hop at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the dodge at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in proficiency of the catch at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in sedentary time at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in vigorous intensity physical activity at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in perceived competence in fundamental movement skills at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))
  • Change from baseline in physical self perceptions at end intervention (9 months) and follow up (3 years)(Baseline (month 0), End-intervention (9 months), Follow-up (3 years))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee Graves

Lecturer

Liverpool John Moores University

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