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临床试验/NCT03356262
NCT03356262进行中(未招募)不适用

The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort

St. Justine's Hospital0 个研究点目标入组 630 人开始时间: 2005年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
630
主要终点
Body mass index (BMI)

研究概览

简要总结

The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort study is a unique and comprehensive longitudinal study of 630 Caucasian children and their parents that was designed to investigate the natural history and determinants of childhood obesity and its cardiometabolic consequences.

详细描述

The QUALITY Cohort is funded by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Canada, as well as the Fonds de la recherche en santé du Québec. The multidisciplinary study team comprises over 20 researchers with a wide variety of relevant expertise as well as research fellows, students and staff (www.etudequalitystudy.ca).

The specific objectives of QUALITY are: 1) To increase understanding of the natural history of excess weight and its associated cardiometabolic consequences (dyslipidemia, hyperinsulinemia, dysglycemia, inflammation, elevated blood pressure, sympathetic overactivity) in youth at risk for the development of obesity; 2) To investigate the relative importance of the genetic, biological, environmental and psychosocial determinants of excess weight and its associated cardiometabolic consequences. Determinants of particular interest include social factors (socio-economic status, family composition, built environment), behavioural factors (eating behaviour, physical activity, smoking, sleep, stress), biological factors (adverse fetal environment, body fat distribution, growth trajectory, aerobic fitness), metabolic factors (insulin sensitivity, adipocytokines), and genetic/familial factors (family history, parental characteristics, gene variations); 3) To examine the relation between obesity, cardiometabolic complications, and subclinical markers of atherosclerosis; and 4) To examine whether obesity and its associated risk factor are related to children's oral health.

The QUALITY Cohort used a school-based sampling strategy to identify potential participants. About 400 000 recruitment flyers were distributed over three consecutive years to parents of children in Grades 2 to 5, in 1040 primary schools (89% of schools approached) including 44 private schools situated within 75 km of Montreal, Quebec City and Sherbrooke in the province of Quebec, Canada. Families interested in participating were invited to contact the research coordinator for additional information, to confirm eligibility, and to set an appointment with the research team; 1320 of 3350 families who contacted the coordinator met the inclusion criteria. Six hundred and thirty families agreed to participate and completed the baseline evaluation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Children aged 8-10 years at baseline;
  • Caucasian of Western European ancestry;
  • At least one obese biological parent (i.e., body mass index (BMI) ≥30 kg/m2 or waist circumference >102 cm in men and >88 cm in women, based on self-reported measurements of height, weight and waist circumference)
  • Both biological parents available to participate in the baseline assessment.

排除标准

  • Children with a previous diagnosis of Type 1 or 2 diabetes;
  • Children with a previous diagnosis of a serious illness, psychological condition, or cognitive disorder which hindered participation in some or all of the study components;
  • Children treated with anti-hypertensive medication or steroids (except if administered topically or through inhalation);
  • Children following a very restricted diet (< 600 kcal/day);
  • Mother pregnant or breastfeeding at the baseline evaluation;
  • Family with pending plans to move out of the province of Quebec (Canada).

结局指标

主要结局

Body mass index (BMI)

时间窗: Through study completion, 13 - 14 years post baseline

Weight (kg) and height (m) will be combined to report BMI in kg/m\^2 and transformed to z-scores using WHO standards

次要结局

  • % body fat mass(Through study completion, 13 - 14 years post baseline)
  • Impaired glucose tolerance(Through study completion, 13 - 14 years post baseline)
  • Hypertension (diastolic)(Through study completion, 13 - 14 years post baseline)
  • Dyslipidemia(Through study completion, 13 - 14 years post baseline)
  • Waist circumference(Through study completion, 13 - 14 years post baseline)
  • Impaired fasting glucose(Through study completion, 13 - 14 years post baseline)
  • Type 2 diabetes(Through study completion, 13 - 14 years post baseline)
  • Hypertension (systolic)(Through study completion, 13 - 14 years post baseline)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Henderson

Clinical assistant professor

St. Justine's Hospital

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