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临床试验/NCT04056377
NCT04056377进行中(未招募)不适用

The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study

North-West University, South Africa2 个研究点 分布在 1 个国家目标入组 1,065 人开始时间: 2017年9月12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
1,065
试验地点
2
主要终点
To determine blood pressure classification among primary school children in South Africa

研究概览

简要总结

The ExAMIN Youth SA study aims to generate new knowledge on the pathophysiology involved in early vascular aging among South African children and to identify early novel biological markers for predicting the subclinical development of hypertension and target organ damage related to cardiovascular disease. This study further implements state-of-the-art biochemical technology to measure a variety of biological markers including multiplex analyses and metabolomics. With the increasing prevalence of childhood hypertension and obesity, this study will be able to address especially behavioural contributors to hypertension development and to subsequently provide a backdrop for school-based primary prevention interventions.

详细描述

Background: The current global widespread incidence of obesity and early cardiovascular deterioration are two of the most important future health care challenges. Physical inactivity and its associated unhealthy dietary intake among adolescents are of great concern, especially in a South African setting in which no current monitoring occurs to describe the impact of this sedentary and unhealthy lifestyle on cardiovascular health. With the estimated global prevalence of elevated blood pressure among children between 12-25%, there is a definite need to contribute to the lack of population level data in South Africa and how lifestyle behaviours impact on the burden of non-communicable disease.

Main aim: Our current study aims to build on previous findings to identify potential contributing factors that may adversely affect health outcomes in South African children. Additionally, we will cross-compare data with international centres on these health outcomes, and finally develop predictive models on target organ damage at 4-years follow-up from baseline data.

Design/Methods: We phenotyped a cohort of 1065 primary school children (all sexes, all ethnic groups and ages 5-9 years) according to their physical fitness and coordination, their dietary behaviours, psychosocial behaviour and current cardiovascular state. Parents of participating children provided information on socio-demographics including data on education, employment, types of dwelling, household amenities and parents' marital status, health habits, and lifestyle. The children will underwent the following measurements: anthropometric measurements of height, weight, waist circumference, triceps and subscapular skinfolds; stable isotope and bioelectric impedance analysis to measure body composition; blood pressure along with pulse wave analysis and aortic pulse wave velocity, static retinal vessel analysis (without mydriasis); accelerometry and a standardised physical activity questionnaire to measure physical activity. Physical fitness measures included motor skills, coordination, flexibility and cardio-respiratory fitness. Urinalysis will include creatinine, albumin, electrolytes, nitrates, nitrites, dimethylarginines, malondialdehyde, glucose, cardiovascular and kidney multiplex panels, and targeted metabolomics. Salivary analyses will include sex hormones and cortisol.

Outcomes: The primary outcomes for the baseline analysis include blood pressure, pulse wave velocity and retinal vascular calibres to address micro- and macrovascular compromise in relation to behavioural risk factors. In the follow-up phase of the study we will include carotid intima media thickness and left ventricular mass as outcomes of baseline predictors.

Timetable: The project was approved and is endorsed by the District Director of the Department of Education, and was approved by the Health Research Ethics Committee of the North-West University on 10 may 2017 (NWU-00091-16-A1). Data collection started in September 2017 and baseline measurements were concluded on 30 April 2019. Follow-up assessments will commence immediately in subsequent years for the 4-year follow-up phase of the study.

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
62 Months 至 129 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children between ages 5 and 9 years (both sexes and all ethnicities).

排除标准

  • Children who do not wish to participate or where the parents or caregivers did not provide permission.

研究组 & 干预措施

White girls

224 white girls were included in the study (mean age 7.4 years)

Black boys

240 black boys were included in the study (mean age 7.5 years)

Black girls

339 black girls were included in the study (mean age 7.5 years)

White boys

239 white boys were included in the study (mean age 7.4 years)

结局指标

主要结局

To determine blood pressure classification among primary school children in South Africa

时间窗: Through study completion, an average of 1 year

Elevated blood pressure and stage 1 hypertension according to the American Academy of Pediatrics Clinical Practice Guidelines 2017 stratified for age, sex, weight and height. Automated oscillometric calculations of central systolic blood pressure and pulse wave velocity.

To identify novel biomarkers in predicting elevated blood pressure in primary school children from South Africa

时间窗: Through study completion, an average of 1 year

Multiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations

To determine overweight and obesity prevalence among primary school children in South Africa

时间窗: Through study completion, an average of 1 year

Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity

次要结局

  • Associations of central blood pressure and aortic stiffness and childhood adversity(Through study completion, an average of 1 year)
  • Associations of central blood pressure and aortic stiffness with body composition(Through study completion, an average of 1 year)
  • Associations of central blood pressure and aortic stiffness and dietary intake(Through study completion, an average of 1 year)
  • Associations of central blood pressure and aortic stiffness with physical fitness(Through study completion, an average of 1 year)

研究者

发起方
North-West University, South Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruan Kruger

Professor

North-West University, South Africa

研究点 (2)

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