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Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04056377
Acronym
ExAMIN-Youth
Enrollment
1065
Registered
2019-08-14
Start date
2017-09-12
Completion date
2027-12-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Hypertension, Retinal Artery Stenosis

Keywords

Hypertension, Retinopathy, Obesity, Arterial stiffness, Physical inactivity

Brief summary

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.

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.

Interventions

None listed

Sponsors

North-West University, South Africa
Lead SponsorOTHER
National Research Foundation of South Africa
CollaboratorOTHER
Medical Research Council, South Africa
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
62 Months to 129 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To determine blood pressure classification among primary school children in South AfricaThrough study completion, an average of 1 yearElevated 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 determine overweight and obesity prevalence among primary school children in South AfricaThrough study completion, an average of 1 yearOverweight and obesity classification according to the World Health Organisation percentiles for childhood obesity
To identify novel biomarkers in predicting elevated blood pressure in primary school children from South AfricaThrough study completion, an average of 1 yearMultiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations

Secondary

MeasureTime frameDescription
Associations of central blood pressure and aortic stiffness with physical fitnessThrough study completion, an average of 1 yearPhysical fitness (cardiorespiratory fitness, coordination, endurance, speed, balance) and activity (accelerometry)
Associations of central blood pressure and aortic stiffness with body compositionThrough study completion, an average of 1 yearAnthropometry including body heigh, body weight, waist-to-height ratio, and body fat percentage
Associations of central blood pressure and aortic stiffness and dietary intakeThrough study completion, an average of 1 yearHealthy and unhealthy food consumption frequencies determined by validate survey to depict unhealthy and healthy food group patterns
Associations of central blood pressure and aortic stiffness and childhood adversityThrough study completion, an average of 1 yearEarly life stress events as quantified by validated psychosocial questionnaires.

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026