Condition category
Infections and Infestations
Date applied
15/08/2014
Date assigned
01/10/2014
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
uwe.puehse@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Uwe Pühse

ORCID ID

Contact details

University of Basel
Department of Sport
Exercise and Health
Birsstrasse 320 B
CH-4052 Basel
Basel
4052
Switzerland
+41 (0)61 377 8780/84
uwe.puehse@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

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.

Condition

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

Intervention

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

Mixed

Phase

Drug names

Primary outcome measures

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

01/09/2014

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Both

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

01/09/2014

Recruitment end date

31/08/2017

Locations

Countries of recruitment

South Africa

Trial participating centre

University of Basel
Basel
4052
Switzerland

Sponsor information

Organisation

University of Basel (Switzerland)

Sponsor details

Department of Sport
Exercise and Health (DSBG)
Birsstrasse 320 B
CH-4052 Basel
Basel
4052
Switzerland
+41 (0)61 377 8757/59
sekretariat-dsbg@unibas.ch

Sponsor type

University/education

Website

https://dsbg.unibas.ch/

Organisation

Nelson Mandela Metropolitan University (South Africa)

Sponsor details

Department of Human Movement Science
Port Elizabeth
-
South Africa

Sponsor type

University/education

Website

Organisation

Swiss Tropical and Public Health Institute (Switzerland)

Sponsor details

-
Basel
-
Switzerland

Sponsor type

Research organisation

Website

Funders

Funder type

Government

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

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26700478
2016 results in: http://parasitesandvectors.biomedcentral.com/articles/10.1186/s13071-016-1761-5

Publication citations

Additional files

Editorial Notes

06/09/2016: Publication reference added. 20/06/2016: Publication reference added.