Condition category
Not Applicable
Date applied
20/07/2018
Date assigned
09/08/2018
Last edited
08/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aim
Ensuring healthy lives and promoting wellbeing among children is a complex and challenging endeavour. In low- and middle-income countries, infectious diseases remain a key public health problem, which negatively impacts on children’s physical and cognitive development, resulting in reduced fitness and work productivity.
Additionally, non-communicable diseases (chronic diseases that cannot be passed from person to person) are a rapidly growing public health problem and impose a considerable burden on population health. Consequently, children are at an increased risk of compromised health due to non-communicable and/or infectious diseases, which may hamper their development and wellbeing. In summary, a deprived socio-economic environment can put children at risk of malnutrition and poor growth. Malnutrition has been found to be associated with stunting and poor cognitive development resulting in low IQ and development delays.
One way of addressing this disease burden and disrupting the vicious cycle of poverty and poor health is to incorporate health promotion measures within existing school structures.
The aim of this project is to assess how effective school-based intervention programmes are on communicable diseases, risk factors for non-communicable diseases, health behaviours (beliefs and actions relating to health and wellbeing) and psychosocial health in school-aged children in disadvantaged neighbourhoods in South Africa, Tanzania and Côte d'Ivoire.

Who can participate?
Children in grades 1-4 aged between 6 and 12 years (at baseline)

What does the study involve?
Children will take part in a school-based health promotion program that lasts for 2 consecutive school years. This involves 1 weekly 40 minute lesson of physical education, 1 weekly 40 minute moving-to-music lesson, as well as 3 health education and nutrition education lessons (all 40 minutes long) per school year. Intervention teachers will receive complete lessons plans and additional training/support by a teacher coach during the first study year. In the second year, the intervention teachers are now asked to implement the contents of the provided lesson plans independently.
Children will also undergo deworming (helminths) using a single dose of albendazole. Participants will be assessed at baseline (beginning of school year), T1 (end of first intervention school year) and T2 (end of second intervention school year). Measures include physical activity and fitness, multi-micronutrient status, disease history, blood tests, body measurements, parasites (helminths), school grades, life satisfaction, and quality of life. Children with poor chronic conditions (e.g., type 2 diabetes) will be referred to a nearby health facility for treatment and care under experienced medical personnel.

What are the possible benefits and risks of participating?
The possible benefit to participants taking part in this study is that school-based health intervention programs have been shown to have positive effects on children's physical activity levels and being overweight/obese. The planned tests are mostly non-invasive and there are no known risks for these data collection methods. Capillary blood sampling via finger pricks may cause slight discomfort. As a result, children will not be pricked more than twice. Deworming will be done using albendazole, which may have minor adverse effects such as dizziness, but these are usually mild and transient.
All procedures are standardized and follow current WHO guidelines, and medical clinicians will be prepared to treat participants in case of emergencies.

Where is the study run from?
University of Basel, Switzerland
Swiss Tropical and Public Health Institute, Basel, Switzerland
Nelson Mandela University, Port Elizabeth, South Africa
Ifakara Health Institute, Ifakara, Tanzania
Centre Suisse de Recherches Scientifiques, Abidjan, Côte d’Ivoire

When is the study starting and how long is it expected to run for?
January 2018 to December 2021

Who is funding the study?
Fondation Botnar (Switzerland)

Who is the main contact?
Professor Dr Markus Gerber
markus.gerber@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus Gerber

ORCID ID

http://orcid.org/0000-0001-6140-8948

Contact details

University of Basel
Department of Sport
Exercise
and Health (DSBG)
Birsstrasse 320B
Basel
4052
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Fondation Botnar Study Nr. 6071

Study information

Scientific title

Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: The KaziAfya project

Acronym

KaziAfya

Study hypothesis

Specific hypotheses for each of our main outcome variables have been formulate, taking into account existing evidence from previous studies, mostly carried out with children living in Western societies:
1. The levels of total physical activity (PA) will increase among children who take part in a school-based PA programme, particularly intra-curricular physical activity
2. Cardiorespiratory fitness will increase among children in the PA and multi-micronutrient supplementation (MMS) + PA condition, independent of children’s gender or weight status
3. The PA intervention might be associated with a decreased BMI in overweight or obese children.
4. Children in the multi-micronutrient supplementation intervention and MMS + PA intervention arm will have reduced adiposity and increased free fat mass (FFM)
5. Children in the MMS and MMS + PA group will have significantly increased serum concentrations of the micronutrients included in the supplement and reduced deficiencies
6. PA and MMS + PA will result in increased adiponectin levels, whereas levels of leptin and ghrelin are expected to remain unchanged
7. Children in the MMS and MMS + PA groups will have reduced serum leptin concentrations and increased adiponectin concentrations
8. Children in the PA, MMS and MMS + PA groups will have reduced levels of inflammatory markers
9. Children in the PA and MMS + PA groups will have decreased blood pressure, improved blood lipid profiles and decreased blood glucose levels
10. Children in the MMS and MMS + PA groups will have reduced cardio-metabolic risk
11. Children in the PA, MMS and MMS + PA groups will have increased executive function and cognitive performance
12. Children in the PA and MMS + PA groups will have improved health-related quality of life and school stress
13. Children in the MMS and MMS + PA groups will have increased health-related quality of life and well-being
14. Children in the MMS and MMS + PA groups will have slower reinfection rates with parasites

Ethics approval

We seek ethical approval from the following responsible ethics committees:
Switzerland (submitted Req-2018-00608):
Ethikkommission Nordwest- und Zentralschweiz (EKNZ). Here, we applied for a "declaration of no objection" (Zuständigkeitsabklärung) for our planned project.

South Africa (submitted):
1. Nelson Mandela University in Port Elizabeth, South Africa
2. Department of Health and to the Department of Education of the Eastern Cape Province, South Africa, respectively

Tanzania (submitted):
1. Ifakara Health Institute – Institutional Review Board (IHI-IRB)
2. Tanzania Food and Drugs Authority (TFDA)
3. National Institute for Medical Research (NIMR)

Côte d’Ivoire (approved 02/07/2018):
Institutional Research Commission of the Centre Suisse de Recherches Scientifiques en Côte d’Ivoire (CSRS; Abidjan) and Comité National d’Ethique et de la Recherche (CNER), 100-18/MSHP/CNESVS-km

Study design

Interventional double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

School-based physical activity and multi-micronutrient supplementation to increase health and improve health-related behaviours

Intervention

3 intervention groups will be compared against one placebo control condition (4 groups in total):
1. Physical activity and placebo
2. Multi-micronutrient supplementation
3. Physical activity and multi-micronutrient supplementation
To ensure allocation concealment, group assingment will be done by a computer-generated code prior to the baseline assessment. This study involves primary school children from grade 1 to grade 4; therefore, each grade level per schoolwill be randomly allocated to one of the 4 groups. To minimise subjective bias, teachers and local study personnel will be blinded regarding whether the tablets are multi-micronutrients or the placebo.
Physical activity will involve 1 40 minute physical education lesson per week and 1 40 minute moving-to-music lesson per week. Additionally, a physical activity-friendly school environment will be developed. Groups 1 and 3 will receive this.
Multi-micronutrient supplementation will involve provision of multi-micronutrient tablets to participants on school days. Groups 2 and 3 will receive this.
Group 1 and the control group will be given placebo tablets.
All groups will receive health education - a series of classroom-based lessons designed to increase awareness of intestinal parasite infections amongst schoolchildren and educate them on treatment and prevention methods, including proper hygiene and sanitation habits and the importance of consuming clean water and food.
All groups will also receive nutritional education - a series of classroom-based lessons designed to increase awareness of the importance of health nutrition.
Additionally, all participants will receive deworming treatment and, if required, referral to local clinics.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The following will be assessed at the baseline, 12 and 24 months post-intervention:
1. Physical activity:
1.1. Self-reported physical activity, assessed using the following:
1.1.1. Single-item tool, taken from the Health-Behaviour in School-Aged Children (HBSC) questionnaire: "Physical activity is any activity that increases your heart rate and makes you get out of breath some of the time. Physical activity can be done in sports, school activities, playing with friends or walking to school. Some examples of physical activity are running, brisk walking, biking, dancing, skateboarding, swimming, soccer, basketball, rugby, cricket. For this next question, add up all the time you spent in physical activity each day. Over the past 7 days, on how many days were you physically active for a total of at least 60 minutes per day?”
1.1.2. 6 items from the Physical Activity Questionnaire for Children (PAQ-C)
1.2. 7 day physical activity measured by actigraphy
2. Physical fitness:
2.1. Cardiorespiratory fitness, assessed using the 20 m shuttle run test from the Eurofit Fitness Testing Battery
2.2. Grip strength, assessed using a grip strength test on both the right and left hands with the Saehan hydraulic hand dynamometer
3. Multi-micronutrient status, assessed using capillary blood sampling via finger prick)


Secondary outcome measures

The following will be measured at the baseline and 12 and 24 months after the intervention:
1. Disease history of child and parents, assessed using a socio-economic and demographic profile questionnaire
2. Subjective health complaints, assessed by the nurse and a questionnaire
3. Haemoglobin concentration (Hb), measured using Haemocue
4. Blood pressure (SBP, DBP), assessed using oscillometry with a digital blood pressure monitor
5. Blood lipids (TC, HDL-C, LDL-C, TG, Non-HDL, C-HDL ratio), measured using the Alere Afinion AS100 analyser
6. Blood glucose (HbA1c), measured using the Alere Afinion AS100 analyser
7. Status of the following, assessed using dried blood spot samples (DBS):
7.1. Vitamin A
7.2. Vitamin D
7.3. Zinc
7.4. Transferrin
7.5. Cytokines (IL-6)
7.6. Leptin
8. Body weight and height, assessed using bioelectrical impedance analysis (BIA)
9. Body composition (body fat), assessed using BIA
10. Waist/hip ratio, assessed using BIA
11. Body Mass Index, assessed using BIA
12. Soil-transmitted helminths (A. lumbricoides, hookworm, T. trichiura), assessed using the Kato-Katz technique
13. Schistosoma mansoni, assessed using the Kato-Katz technique
14. Executive function, assessed using a computer-based version of the Flanker test
15. School grades - end of year results in mathematics, home language and the first additional language
16. Health-related quality of life, assessed using the KIDSCREEN-10 questionnaire
17. Perceived stress, assessed using the Health Behaviours in School Age Children (HBSC) questionnaire
18. School satisfaction, assessed using the HBSC questionnaire
19. Perceived academic competence, assessed using the HBSC questionnaire
20. Sleep, assessed using the following:
20.1. Insomnia Severity Index (ISI)
20.2. Pittsburgh Sleep Quality Index (PSQI)
20.3. Sleep environment

Control variables, assessed via questionnaire at the baseline and 12 and 24 months after the intervention:
21. Age
22. Sex
23. Socioeconomic status
24. Ethnicity
25. Home language
26. School
27. Grade
28. Country


Overall trial start date

01/01/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Attending grade 1 to 4
2. Aged 6 to 12 years (corrected 30/04/2019).
3. Written informed consent by parent/guardian
4. Not participating in other clinical trials
5. Not receiving multi-micronutrient supplements
6. Not suffering from clinical conditions that prevent participation in physical activity, as determined by qualified medical personnel

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

4000

Participant exclusion criteria

1. Congenital or acquired alteration of the gastrointestinal tract, which could impair absorption of the multi-micronutrient supplements
2. Taken vitamin and mineral supplements in the past 6 months.
3. Fetal alcohol syndrome

Recruitment start date

15/10/2018

Recruitment end date

31/07/2019

Locations

Countries of recruitment

Cote d'Ivoire, South Africa, Tanzania

Trial participating centre

Ifakara Health Institute
Plot 463, Kiko Avenue Mikocheni P.O. Box 78 373 Dar es Salaam Tanzania
Dar es Salaam/Ifakara
78373
Tanzania

Trial participating centre

Nelson Mandela University
PO Box 77000 Nelson Mandela University
Port Elizabeth
6031
South Africa

Trial participating centre

CSRS- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Yopougon, Abidjan - 01 BP 1303 Abidjan
Abidjan
01 BP 1303
Cote d'Ivoire

Sponsor information

Organisation

Fondation Botnar

Sponsor details

St.Alban Vorstadt 56
Basel
4052
Switzerland
+41 61 201 04 74
info@fondationbotnar.org

Sponsor type

Other

Website

https://www.fondationbotnar.org/contact

Funders

Funder type

Not defined

Funder name

Fondation Botnar

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We aim to publish our:
1. Study protocol on 30/09/2018
2. Baseline data on 01/07/2019
3. 12 months follow-up data on 01/07/2020
4. 24 months follow-up data on 01/07/2021

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/10/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31907019 (added 08/01/2020)

Publication citations

Additional files

Editorial Notes

08/01/2020: Publication reference added. 30/04/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 15/03/2019 to 31/07/2019. 2. The intention to publish date was changed from 30/09/2018 to 30/10/2020. 3. The participant inclusion criteria were corrected (typographical error). 01/03/2019: The public title was corrected (typographical error).