- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04056377
Exercise, Arterial Modulation and Nutrition in Youth South Africa Study (ExAMIN-Youth)
The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North West
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Potchefstroom, North West, South Africa, 2531
- Hypertension in Africa Research Team (HART), North-West University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children between ages 5 and 9 years (both sexes and all ethnicities).
Exclusion Criteria:
- Children who do not wish to participate or where the parents or caregivers did not provide permission.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Black boys
240 black boys were included in the study (mean age 7.5 years)
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Black girls
339 black girls were included in the study (mean age 7.5 years)
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White boys
239 white boys were included in the study (mean age 7.4 years)
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White girls
224 white girls were included in the study (mean age 7.4 years)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine blood pressure classification among primary school children in South Africa
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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To determine overweight and obesity prevalence among primary school children in South Africa
Time Frame: Through study completion, an average of 1 year
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Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity
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Through study completion, an average of 1 year
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To identify novel biomarkers in predicting elevated blood pressure in primary school children from South Africa
Time Frame: Through study completion, an average of 1 year
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Multiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Associations of central blood pressure and aortic stiffness with physical fitness
Time Frame: Through study completion, an average of 1 year
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Physical fitness (cardiorespiratory fitness, coordination, endurance, speed, balance) and activity (accelerometry)
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Through study completion, an average of 1 year
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Associations of central blood pressure and aortic stiffness with body composition
Time Frame: Through study completion, an average of 1 year
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Anthropometry including body heigh, body weight, waist-to-height ratio, and body fat percentage
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Through study completion, an average of 1 year
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Associations of central blood pressure and aortic stiffness and dietary intake
Time Frame: Through study completion, an average of 1 year
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Healthy and unhealthy food consumption frequencies determined by validate survey to depict unhealthy and healthy food group patterns
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Through study completion, an average of 1 year
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Associations of central blood pressure and aortic stiffness and childhood adversity
Time Frame: Through study completion, an average of 1 year
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Early life stress events as quantified by validated psychosocial questionnaires.
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Through study completion, an average of 1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the change in blood pressure over a 4-year follow-up period in primary school children of South Africa
Time Frame: Through study completion, 4 years after baseline measurements
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Automated oscillometric calculations of central systolic blood pressure and pulse wave velocity at baseline and 4-years follow-up
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Through study completion, 4 years after baseline measurements
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Determine baseline predictors of target organ damage markers after a 4-year follow-up period in primary school children of South Africa
Time Frame: Through study completion, 4 years after baseline measurements
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Target organ damage will be assessed at follow-up by carotid intima media thickness and left ventricular mass.
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Through study completion, 4 years after baseline measurements
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Collaborators and Investigators
Publications and helpful links
General Publications
- Kochli S, Smith W, Lona G, Goikoetxea-Sotelo G, Breet Y, Botha-Le Roux S, Mokwatsi GG, Kruger R, Hanssen H. Obesity, blood pressure and retinal microvascular phenotype in a bi-ethnic cohort of young children. Atherosclerosis. 2022 Jun;350:51-57. doi: 10.1016/j.atherosclerosis.2022.04.018. Epub 2022 Apr 21.
- Kruger R, Kruger HS, Monyeki MA, Pienaar AE, Roux SB, Gafane-Matemane LF, Smith W, Mels CMC, Lammertyn L, Brits JS, Hanssen H. A demographic approach to assess elevated blood pressure and obesity in prepubescent children: the ExAMIN Youth South Africa study. J Hypertens. 2021 Nov 1;39(11):2190-2199. doi: 10.1097/HJH.0000000000002917.
- Kochli S, Botha-Le Roux S, Uys AS, Kruger R. Cardiorespiratory Fitness, Blood Pressure and Ethnicity Are Related to Salivary Cortisol Responses after an Exercise Test in Children: The ExAMIN Youth SA Study. Int J Environ Res Public Health. 2021 Jul 26;18(15):7898. doi: 10.3390/ijerph18157898.
- Kruger R, Monyeki MA, Schutte AE, Smith W, Mels CMC, Kruger HS, Pienaar AE, Gafane-Matemane LF, Breet Y, Lammertyn L, Mokwatsi GG, Kruger A, Deacon E, Hanssen H. The Exercise, Arterial Modulation and Nutrition in Youth South Africa Study (ExAMIN Youth SA). Front Pediatr. 2020 Apr 29;8:212. doi: 10.3389/fped.2020.00212. eCollection 2020.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NWU-00091-16-A1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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