Hypertension Clinical Trial
— ExAMIN-YouthOfficial title:
The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study
Verified date | January 2024 |
Source | North-West University, South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1065 |
Est. completion date | December 31, 2027 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 62 Months to 129 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | Hypertension in Africa Research Team (HART), North-West University | Potchefstroom | North West |
Lead Sponsor | Collaborator |
---|---|
North-West University, South Africa | Medical Research Council, South Africa, National Research Foundation of South Africa |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Determine the change in blood pressure over a 4-year follow-up period in primary school children of South Africa | Automated oscillometric calculations of central systolic blood pressure and pulse wave velocity at baseline and 4-years follow-up | Through study completion, 4 years after baseline measurements | |
Other | Determine baseline predictors of target organ damage markers after a 4-year follow-up period in primary school children of South Africa | Target organ damage will be assessed at follow-up by carotid intima media thickness and left ventricular mass. | Through study completion, 4 years after baseline measurements | |
Primary | To determine blood pressure classification among primary school children in South Africa | 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. | Through study completion, an average of 1 year | |
Primary | To determine overweight and obesity prevalence among primary school children in South Africa | Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity | Through study completion, an average of 1 year | |
Primary | To identify novel biomarkers in predicting elevated blood pressure in primary school children from South Africa | Multiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations | Through study completion, an average of 1 year | |
Secondary | Associations of central blood pressure and aortic stiffness with physical fitness | Physical fitness (cardiorespiratory fitness, coordination, endurance, speed, balance) and activity (accelerometry) | Through study completion, an average of 1 year | |
Secondary | Associations of central blood pressure and aortic stiffness with body composition | Anthropometry including body heigh, body weight, waist-to-height ratio, and body fat percentage | Through study completion, an average of 1 year | |
Secondary | Associations of central blood pressure and aortic stiffness and dietary intake | Healthy and unhealthy food consumption frequencies determined by validate survey to depict unhealthy and healthy food group patterns | Through study completion, an average of 1 year | |
Secondary | Associations of central blood pressure and aortic stiffness and childhood adversity | Early life stress events as quantified by validated psychosocial questionnaires. | Through study completion, an average of 1 year |
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