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

• Register: ISRCTN
• Last refreshed on: 2 November 2020
• Main ID: ISRCTN68411960
• Date of registration: 01/10/2014
• Prospective Registration: No
• Primary sponsor: University of Basel
• Public title: Impact of disease burden and setting-specific interventions on schoolchildren?s cardio-respiratory physical fitness and psychosocial health in Port Elizabeth, South Africa
• 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
• Date of first enrolment: 01/09/2014
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68411960
• Study type: Interventional
• Study design: 1. Cross-sectional clinical epidemiological survey; 2. Cluster randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

South Africa

Contacts

• Name: Uwe Pühse

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender: Both

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)
Infections and Infestations

Intervention(s)

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.

Primary Outcome(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.

Secondary Outcome(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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Swiss Tropical and Public Health Institute (Switzerland)

Nelson Mandela Metropolitan University (South Africa)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/08/2017