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临床试验/NCT04143074
NCT04143074Unknown不适用

"Population Activities in the Field of Prevention, Early Identification and Treatment of Overweight and Obesity in Gdansk Children and Youth Population"

Michał Brzeziński2 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
6,000
试验地点
2
主要终点
body mass change

研究概览

简要总结

"6-10-14 for Health" is an integrated weight-loss intervention programme for obese children from Gdansk municipality. Both participants of the programme and their family members are offered a 12-month integrated intervention, including medical, dietetic and psychological counselling, as well as educational workshops for parents.

详细描述

"6-10-14 for Health" is an integrated weight-loss intervention programme for obese children from Gdansk municipality. Both participants of the programme and their family members are offered a 12-month integrated intervention, including medical, dietetic and psychological counselling, as well as educational workshops for parents.

The programme, financed by the municipality of Gdansk, is devided in three phases:

  1. Screening - all children aged 6, 9-11, 14 years of age from the City of Gdansk are being screened yearly. All children attending primary and grammar schools in Gdansk are subjected to a screening. The population size is between 9.000-10.000 children yearly.

All children have anthropometric measurements (body mass, body height, waist circumference), blood pressure, cardiorespiratory fitness.

Anthropometry: Body weight and body height are determined with a digital scale (Mensor WE150, Poland), with the child wearing an underwear and standing barefoot. Body height is measured to the nearest 0.001 m, and body weight to the nearest 0.1 kg. The scale is calibrated every day. Waist and hip circumferences are measured on a horizontal plane by an Ergonomic Circumference Measuring Tape (model 201; Seca GmbH & Co, KG, Hamburg, Germany).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children living in Gdansk (for screening phase)
  • children with BMI above 85 percentile (for intervention phase)
  • consent of parent/ caregivers

排除标准

  • confirmed congenital or metabolic diseases connected with obesity risk
  • lack of consent of parent/ caregivers

研究组 & 干预措施

intervention

Other

multidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer

干预措施: multidisciplinary behavioral intervention (Behavioral)

结局指标

主要结局

body mass change

时间窗: 12 months from begining of intervention

Number (percentage) of participants with change of: body mass of 5% or centiles of BMI by 5 percentile points or z-score BMI change by 0,25

次要结局

  • body fat reduction(12 months from begining of intervention)

研究者

发起方
Michał Brzeziński
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michał Brzeziński

Assistant Professor, Primary Investigator

University Clinical Centre, Gdansk

研究点 (2)

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