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

ISRCTN	ISRCTN68411960
DOI	https://doi.org/10.1186/ISRCTN68411960
Protocol serial number	N/A
Sponsors	University of Basel, Nelson Mandela Metropolitan University (South Africa), Swiss Tropical and Public Health Institute (Switzerland)
Funder	Swiss National Science Foundation (SNSF) (reference no. IZLSZ3_149015) (Switzerland)

Submission date: 15/08/2014
Registration date: 01/10/2014
Last edited: 22/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Uwe Pühse
Scientific

University of Basel
Department of Sport, Exercise and Health
Birsstrasse 320 B
CH-4052 Basel
Basel
4052
Switzerland

Phone	+41 (0)61 377 8780/84
Email	uwe.puehse@unibas.ch

Study information

Primary study design	Interventional
Study design	1. Cross-sectional clinical epidemiological survey 2. Cluster randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/08/2017

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	9 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	1000
Key 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.
Key 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.
Date of first enrolment	01/09/2014
Date of final enrolment	31/08/2017

Locations

Countries of recruitment

South Africa
Switzerland

Study participating centre

University of Basel

Basel
4052
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/09/2016		Yes	No
Results article	observational results	08/05/2017	08/04/2020	Yes	No
Results article	results	27/11/2017	08/04/2020	Yes	No
Results article	results	08/11/2018	08/04/2020	Yes	No
Results article	results	01/10/2017	08/04/2020	Yes	No
Results article	results	15/01/2019	08/04/2020	Yes	No
Results article	results	01/11/2016	08/04/2020	Yes	No
Results article	results	01/01/2018	08/04/2020	Yes	No
Results article	results	15/03/2018	08/04/2020	Yes	No
Results article	results	01/07/2018	08/04/2020	Yes	No
Results article	results	10/09/2020	22/10/2020	Yes	No
Protocol article	protocol	23/12/2015		Yes	No
Other publications	situational analysis	01/09/2017	08/04/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.

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