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 childrens physical fitness and psychosocial health. In turn, such insights are required to tailor setting-specific interventions (treatments or programmes) to improve childrens 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 childrens 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 dont 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 schoolchildrens 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 childrens 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 childrens 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 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
01/09/2014
Overall trial end date
31/08/2017
Reason abandoned (if study stopped)
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 guardians 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
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, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
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