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Impact of disease burden and setting-specific interventions on schoolchildren?s cardio-respiratory physical fitness and psychosocial health in Port Elizabeth, South Africa

Impact of disease burden and setting-specific interventions on schoolchildren?s cardio-respiratory physical fitness and psychosocial health in Port Elizabeth, South Africa: a cross-sectional epidemiological survey and cluster randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68411960
Enrollment
1000
Registered
2014-10-01
Start date
2014-09-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

Communicable diseases (e.g. intestinal protozoa and helminth infections) and non-communicable chronic conditions (e.g. type 2 diabetes and malnutrition) Infections and Infestations

Interventions

The following intervention toolbox is proposed but the specific combination of interventions to be used will be governed by the key findings from the initial cross-sectional baseline survey: Physical

Sponsors

University of Basel
Lead Sponsor
Nelson Mandela Metropolitan University (South Africa)
Collaborator
Swiss Tropical and Public Health Institute (Switzerland)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Willing to participate in the study 2. Be in possession of a written informed consent by a parent/guardian on behalf of the child 3. Not participating in other studies 4. Being a primary school child aged 9-12 years, male or female 5. Absence of ill-health condition (e.g. severe anaemia, respiratory disease or other major illnesses), as assessed by a medical doctor at baseline.

Exclusion criteria

Exclusion criteria: 1. Children below the age of 9 years or above 12 years 2. Not having a written informed consent or no parental/legal guardian?s permission to participate 3. Suffer from medical conditions which prevent participation in the study, as determined by qualified medical personnel 4. Attending other clinical trials during the study period.

Design outcomes

Primary

MeasureTime frame
1. The prevalence of communicable diseases (e.g. intestinal protozoa and helminth infections) and non-communicable chronic conditions (e.g. type 2 diabetes and malnutrition). 2. Differences (non-infected vs. infected) and changes (before and after treatment) in physical fitness levels, psychosocial health and cognitive performance.

Secondary

MeasureTime frame
1. Reduction of infection prevalence and intensity of soil-transmitted helminths and schistosomiasis. 2. Differences and changes in disease-related morbidity measures (malnutrition and anaemia). Treatment will be administered to all study participants directly after baseline assessments, 1 year and 2 years after baseline. Reassessment of parasitic infection, anthropometric and haemoglobin measurements, clinical examination, physical fitness and cognitive performance will take place at the end of the study follow-up, 2 years after baseline.

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026