Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
An unhealthy diet, high in sugar and salt, and a lack of exercise are both leading risk factors for ill-health. Together, they account for 10% of the global burden of disease (i.e. health-related costs, deaths and disabilities), as expressed in disability-adjusted life years (DALYs). The DALY measures overall disease burden by looking at the number of years lost due to ill-health, disability and early death. Studies have shown that the South African population now have a disease profile (i.e. the population are exposed to similar risk factors and develop similar diseases) similar to that of Western countries, with increasing numbers of deaths and DALYs attributed to chronic diseases. Yet, infectious diseases that are known to be caused by poor living conditions and poverty continue to occur in marginalized communities, such as school-aged children in poor neighbourhoods. The term “dual burden” is being used to describe this issue of growing public health concern. In-depth studies looking at this provide new insights into their impact on children’s physical fitness and psychosocial health. In turn, such insights are required to tailor setting-specific interventions (treatments or programmes) to improve children’s health and wellbeing. We want to look at the burden and distribution (for example, which neighbourhoods) of communicable diseases (e.g. intestinal protozoa and helminth infections) and non-communicable chronic conditions (e.g. type 2 diabetes and malnutrition) among school-aged children in selected schools in Port Elizabeth, South Africa, and to assess their impact on children’s physical fitness and psychosocial health.

Who can participate?
All primary schoolchildren from grade 4 (age range: 9-12 years) from selected disadvantaged schools.

What does the study involve?
All participants are tested for parasites and anaemia, their body measurements are taken, their physical fitness assessed and their cognitive performance tested (memory, attention span etc). For the intervention, treatment against soil-transmitted helminthiasis and schistosomiasis is given, using a single dose of albendazole (400 mg) and praziquantel (40 mg/kg), respectively. Treatment is given to all study participants directly after the assessments at the beginning of the trial (baseline assessments) and then after 1 and 2 years. Reassessment of parasitic infection, presence of anaemia, body measurements, physical fitness and cognitive performance also take place after 2 years.

What are the possible benefits and risks of participating?
There are no specific risks associated with this study. Some participants may find giving stool and urine samples embarrassing but we try to avoid that by telling them why the samples are necessary and important to the study. Fingerprick tests are used to take blood samples. This is a minimally painful and usually well accepted procedure. Albendazole and praziquantel are widely used for preventive chemotherapy. These drugs might result in some side effects, but these are usually mild and don’t last for long. Trained medical personnel involved in this study will take care of the children in case of medical emergencies. All participating children benefit from repeated de-worming with albendazole and praziquantel, two drugs that are recommended by the World Health Organization to control soil-transmitted helminthiasis and schistosomiasis.

Where is the study run from?
Historically black primary schools in the Port Elizabeth township of South Africa

When is the study starting and how long is it expected to run for?
September 2014 to August 2017

Who is funding the study?
Swiss National Science Foundation (SNSF) (Switzerland)

Who is the main contact?
Professor Uwe Pühse

Trial website

Contact information



Primary contact

Prof Uwe Pühse


Contact details

University of Basel
Department of Sport
Exercise and Health
Birsstrasse 320 B
CH-4052 Basel
+41 (0)61 377 8780/84

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

1. The dual burden of communicable diseases and non-communicable chronic conditions in school aged children in selected schools near Port Elizabeth, South Africa, has a negative influence on the children’s cardio-respiratory physical fitness, cognitive performance and psychosocial health.
2. The burden of communicable and non-communicable chronic disease is differently distributed among schools and students with different social and demographic background.
3. Specific health interventions (e.g. lifestyle interventions and deworming) can improve children’s health and wellbeing.

Ethics approval

1. Research Ethics Committee (Human) from the Nelson Mandela Metropolitan University (NMMU), Port Elizabeth, South Africa, 04/07/2014, ref. H14-HEA-HMS-002
2. Ethics Committee northwest/central Switzerland, 01/08/2014, ref. 2014-179

Study design

1. Cross-sectional clinical epidemiological survey
2. Cluster randomized controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


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


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 fitness programmes, health education and administration of nutritional supplements or treatments. All participants of the study will be treated against soil-transmitted helminthiasis and schistosomiasis with a single dose of albendazole (400 mg) and praziquantel (40 mg/kg), respectively, at baseline, 1 year and 2 years (follow-up assessment) after launch of the study.

Intervention type



Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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.

Participant type


Age group




Target number of participants

Approximately 1,000 schoolchildren

Participant 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.

Recruitment start date


Recruitment end date



Countries of recruitment

South Africa

Trial participating centre

University of Basel

Sponsor information


University of Basel

Sponsor details

Department of Sport
Exercise and Health (DSBG)
Birsstrasse 320 B
CH-4052 Basel
+41 (0)61 377 8757/59

Sponsor type




Nelson Mandela Metropolitan University (South Africa)

Sponsor details

Department of Human Movement Science
Port Elizabeth
South Africa

Sponsor type




Swiss Tropical and Public Health Institute (Switzerland)

Sponsor details


Sponsor type

Research organisation



Funder type


Funder name

Swiss National Science Foundation (SNSF) (reference no. IZLSZ3_149015) (Switzerland)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2015 protocol in
2. 2016 results in
3. 2017 results in (added 08/04/2020)
4. 2018 results in (added 08/04/2020)
5. 2018 results in (added 08/04/2020)
6. 2018 results in (added 08/04/2020)
7. 2019 results in (added 08/04/2020)
8. 2018 results in (added 08/04/2020)
9. 2017 situational analysis in (added 08/04/2020)
10. 2017 results in (added 08/04/2020)
11. 2017 observational results in (added 08/04/2020)
12. 2016 results in (added 08/04/2020)
13. 2020 results in (added 22/10/2020)

Publication citations

Additional files

Editorial Notes

22/10/2020: Publication references added. 08/04/2020: Publication references added. 06/09/2016: Publication reference added. 20/06/2016: Publication reference added.