HypertensionExAMIN-YouthNCT04056377
Exercise, Arterial Modulation and Nutrition in Youth South Africa Study
An observational study of Hypertension and Retinal Artery Stenosis, run by North-West University, South Africa at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 62 to 129 monthsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Retinal Artery Stenosis, Childhood Obesity
- How many people
- 1,065 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Sep 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 to 129 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population included 1103 children (at baseline) attending public primary schools in the Dr Kenneth Kaunda district, North West province, South Africa aged between 5 and 9 years of age. However, with a few missing (n=38) values of basic variables of interest such as sex, ethnicity or date of birth, we included a total 1065 children (mean age=7.44 years or 89.3 months). The majority of the participants were of African (n=579) and white (n=463) ethnicity, whereas only 2.2% (n=23) participants were of either Indian or mixed race. The sex distribution was similar in the white group, whereas the study unintentionally included more girls (58.5%) than boys (41.5%) in the black group.
Who may be able to join
- Children between ages 5 and 9 years (both sexes and all ethnicities).
Who cannot join
- Children who do not wish to participate or where the parents or caregivers did not provide permission.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Hypertension in Africa Research Team (HART), North-West University
Potchefstroom, North West, 2531
About this study
Official title: The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study
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.
Read the 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.
- Conditions
- Hypertension, Retinal Artery Stenosis, Childhood Obesity
- Keywords
- Hypertension, Retinopathy, Obesity, Arterial stiffness, Physical inactivity
- Medical subject headings
- Hypertension, Pediatric Obesity, Retinal Diseases, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| White girls | 224 white girls were included in the study (mean age 7.4 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Associations of central blood pressure and aortic stiffness with physical fitness
Physical fitness (cardiorespiratory fitness, coordination, endurance, speed, balance) and activity (accelerometry)
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Associations of central blood pressure and aortic stiffness and childhood adversity
Early life stress events as quantified by validated psychosocial questionnaires.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start12 Sep 2017
- Primary completion30 Apr 2019
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of South Africa, Medical Research Council, South Africa
- Responsible party
- Principal investigator, Ruan Kruger, North-West University, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056377
- Sponsor's protocol ID
- NWU-00091-16-A1
- Acronym
- ExAMIN-Youth
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volschenk C, Jansen van Vuren E, Wentzel A, Kruger R. A prospective analysis to assess the multifactorial risk of childhood-onset hypertension: the ExAMIN Youth SA study. Hypertens Res. 2025 Oct;48(10):2618-2630. doi: 10.1038/s41440-025-02309-6. Epub 2025 Aug 15.
PubMed 40817402Kochli 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.
PubMed 35490596Kruger 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.
PubMed 34620809Kochli 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.
PubMed 34360198Kruger 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.
PubMed 32411640
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study
- ClinicalTrials.gov ID
- NCT04056377
- Acronym / sponsor ID
- ExAMIN-Youth / NWU-00091-16-A1
- Conditions
- Hypertension, Retinal Artery Stenosis, Childhood Obesity
- Keywords
- Hypertension, Retinopathy, Obesity, Arterial stiffness, Physical inactivity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Collaborators
- National Research Foundation of South Africa, Medical Research Council, South Africa
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
| White girls | – | –224 white girls were included in the study (mean age 7.4 years) |
Who may qualify
- Ages
- 62 to 129 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population included 1103 children (at baseline) attending public primary schools in the Dr Kenneth Kaunda district, North West province, South Africa aged between 5 and 9 years of age. However, with a few missing (n=38) values of basic variables of interest such as sex, ethnicity or date of birth, we included a total 1065 children (mean age=7.44 years or 89.3 months). The majority of the participants were of African (n=579) and white (n=463) ethnicity, whereas only 2.2% (n=23) participants were of either Indian or mixed race. The sex distribution was similar in the white group, whereas the study unintentionally included more girls (58.5%) than boys (41.5%) in the black group.
Key inclusion criteria (1 listed)
- Children between ages 5 and 9 years (both sexes and all ethnicities).
Key exclusion criteria (1 listed)
- Children who do not wish to participate or where the parents or caregivers did not provide permission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine blood pressure classification among primary school children in South Africa
Time frame: 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 determine overweight and obesity prevalence among primary school children in South Africa
Time frame: Through study completion, an average of 1 year
Overweight 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 Africa
Time frame: Through study completion, an average of 1 year
Multiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations
4 secondary outcomes
Associations of central blood pressure and aortic stiffness with physical fitness
Time frame: Through study completion, an average of 1 year
Associations of central blood pressure and aortic stiffness with body composition
Time frame: Through study completion, an average of 1 year
Associations of central blood pressure and aortic stiffness and dietary intake
Time frame: Through study completion, an average of 1 year
Associations of central blood pressure and aortic stiffness and childhood adversity
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 40817402Volschenk C, Jansen van Vuren E, Wentzel A, Kruger R. A prospective analysis to assess the multifactorial risk of childhood-onset hypertension: the ExAMIN Youth SA study. Hypertens Res. 2025 Oct;48(10):2618-2630. doi: 10.1038/s41440-025-02309-6. Epub 2025 Aug 15.
- Derived from this study: PubMed 35490596Kochli 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.
- Derived from this study: PubMed 34620809Kruger 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.
- Derived from this study: PubMed 34360198Kochli 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.
- Derived from this study: PubMed 32411640Kruger 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.
- ORCIDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Retinal Artery Stenosis, run by North-West University, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine blood pressure classification among primary school children in South Africa (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.