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临床试验/NCT06179381
NCT06179381尚未招募不适用

FACILITY (Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY)

Buzzi Children's Hospital0 个研究点目标入组 269 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
269
主要终点
Prevalence of childhood overweight and obesity

研究概览

简要总结

The FACILITY STUDY is aimed at evaluating maternal and children social, cultural, economic and lifestyle-related risk factors for the development of childhood overweight, obesity and early adiposity rebound (EAR). This study consists of two phases: a cross-sectional phase and a retrospective case-control study.

详细描述

The FACILITY cross-sectional study is conducted in the Buzzi Children's Hospital in Milan on children and adolescents (2-18 years old) and their mothers (≥ 18 years old). The estimated duration is 24 months.

The primary objective of the FACILITY cross-sectional is the assessment of the nutritional and socioeconomic status of mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy (mapping). Therefore, the primary endpoint is to define the overweight and obesity prevalence in multiethnic mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy.

The secondary objectives are: 1) Assessment of lifestyle factors and their impact on the health status of the target population. 2) Assessment of socioeconomic and cultural factors and their impact on the health status of the target population. Thus, the secondary endpoints are: 1) Impact of lifestyle on overweight and obesity in children/adolescents. 2) Impact of socio-economic-cultural factors on overweight and obesity in children/adolescents.

To mother-child dyads coming to the outpatient facilities (of the Department of Pediatrics, Buzzi Children's Hospital, Milan) and eligible in accordance with the inclusion and exclusion criteria will be proposed to participate in the study and will be given the informative material. For children and adolescents, the informed consent will be read and signed by the parents, who are the legal guardians.

On eligible subject different variables will be measured.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prevalence of childhood overweight and obesity

时间窗: Day 1

Number of children with overweight or obesity divided by the total number of children. Diagnosis: BMI percentile in the Center for Diseases Control (CDC) growth chart (overweight: 85th-95th percentile/2-3 Z score; obesity ≥ 95th percentile/≥ 3 Z score).

次要结局

  • Physical activity for dyads(Day 1)
  • Sleep quality for dyads(Day 1)
  • Height of dyads(Day 1)
  • Mediterranean diet adherence for dyads(Day 1)
  • Family relationships for mothers(Day 1)
  • Social environment for mothers(Day 1)
  • Waist circumference of dyads(Day 1)
  • Dietary patterns of mothers(Day 1)
  • Smoking habits for dyads(Day 1)
  • Alcohol consumption for dyads(Day 1)
  • Sedentary screen time for children(Day 1)
  • Socio-economic status for mothers(Day 1)
  • Personal social capital for mothers(Day 1)
  • Neighborhood food environment for mothers(Day 1)
  • Social participation for mothers(Day 1)
  • Weight of dyads(Day 1)

研究者

发起方
Buzzi Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valeria Calcaterra

Principal Investigator

Buzzi Children's Hospital

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