Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

NCT04056377 | Active Not Recruiting DMC

• 1 other identifier: NWU-00091-16-A1
• Study Type: observational
• Target: 1,065
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Retinal Artery Stenosis; Childhood Obesity

Keywords

Hypertension; Retinopathy; Obesity; Arterial stiffness; Physical inactivity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Associations of central blood pressure and aortic stiffness with physical fitness

  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 and childhood adversity

  Through study completion, an average of 1 year

Other Outcomes (2)

• Determine the change in blood pressure over a 4-year follow-up period in primary school children of South Africa

  Through study completion, 4 years after baseline measurements

• Determine baseline predictors of target organ damage markers after a 4-year follow-up period in primary school children of South Africa

  Through study completion, 4 years after baseline measurements

Study Arms (4)

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)

Eligibility Criteria

• Age: 62 Months - 129 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• North-West University, South Africa: lead
• National Research Foundation of South Africa: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (1)

Hypertension in Africa Research Team (HART), North-West University

Potchefstroom, North West, 2531, South Africa

Location

Related Publications (4)

• 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.

  PMID: 35490596 DERIVED

• 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.

  PMID: 34620809 DERIVED

• 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.

  PMID: 34360198 DERIVED

• 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.

  PMID: 32411640 DERIVED

Related Links

• ORCID

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples for biomarker analyses (spot urine and saliva) were taken at baseline and also for each follow-up. Samples are preserved for both short and long-term at -80°C. We aim to assess a variety of traditional and new biomarkers related to hypertension and cardiovascular disease.

MeSH Terms

Conditions

Hypertension; Pediatric Obesity; Retinal Diseases; Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: September 12, 2017
• Primary Completion: April 30, 2019
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)