Study Design

A cluster randomised, interventional placebo-controlled trial with a 2×2 factorial design.

DOI: 10.1186/ISRCTN29534081

A cluster randomised, interventional placebo-controlled trial with a 2×2 factorial design.

DOI: 10.1186/ISRCTN29534081

Overview

First data assessment

Intervention start

Second data assessment

Intervention end

Third data assessment

Overview

First data assessment

Intervention start

Second data assessment

Intervention end

Third data assessment

Aims of the study

To assess and compare variables related to physical fitness, nutrition, cardiovascular health and more

To determine associations between these variables (bi- and multivariate relationships)

To examine the effects of a school-based health intervention

All variables being assessed:

  • Physical activity
  • Physical fitness
  • Micronutrient status
  • Body composition
  • Nutritional habits
  • Infections with soil-transmitted helminths
  • Infections with schistosoma mansoni
  • Infections with malaria
  • Cardiovascular health risk markers
  • Academic and cognitive performafnce
  • Health-related quality of life
  • Sleep

Aims of the study

To assess and compare variables related to physical fitness, nutrition, cardiovascular health and more

To determine associations between these variables (bi- and multivariate relationships)

To examine the effects of a school-based health intervention

All variables being assessed:

  • Physical activity
  • Physical fitness
  • Micronutrient status
  • Body composition
  • Nutritional habits
  • Infections with soil-transmitted helminths
  • Infections with schistosoma mansoni
  • Infections with malaria
  • Cardiovascular health risk markers
  • Academic and cognitive performafnce
  • Health-related quality of life
  • Sleep

Subjects

The study takes place in Côte d’Ivoire, South Africa and Tanzania.

1’300 children from each country are part of the study (and only if their parents have given informed consent).

At baseline all children are aged 6 to 12 years and currently enrolled at a public primary school.

Data assessment

We collect data over a span of 2 schoolyears. Each child is measured three times.

First data assessment (T1)

Baseline: At the very beginning of the study.

Second data asessment (T2)

9 months after baseline.

Third data assessment (T3)

21 months after baseline.

Intervention

Participants are randomly assigned to one of four intervention groups.

Group 1

PA + MMNS

Group 2

PA + Placebo

Group 3

MMNS alone

Group 4

Placebo (control)

Depending on the intervention group, the children receive one or both of the following intervention:

Physical activity (PA): Children receive 1 physical education and 1 moving-to-music lesson per weeek (duration of each lesson: 45min). These lessons are based on the KaziKidz toolkit and are freely available online.

Physical education lesson based on KaziKidz: Grade 3, spatial orientation

Multi-micronutrient supplementation (MMNS): A specially designed chewing tablet, containing a selection of micronutrients.

Nutrient Average per
1 tablet
ß-Carotene
(as BetaTab 20%S)		 3.6 mg
Vitamin D 400 IU / 10 mcg
Vitamin E 9 mg TE
Vitamin K 30 mcg
Vitamin C 60 mg
Vitamin B1 1.1 mg
Vitamin B2 1.3 mg
Vitamin B6 0.5 mg
Vitamin B12 1.2 mcg
Folic Acid 200 mcg
Niacinamide 8 mg
Iron (added as Fe-EDTA) 10 mg
Zinc (added as zinc oxide) 5 mg
Selenium (added as sodium selenite anhydrous) 20 mcg
Iodine (added as potassium iodate) 100 mcg

Additionally, all participants of the study receive:

  • Health and nutrition lessons
  • Depending on infection status: Deworming
  • Depending on health status: Clinical referral and follow-up

For more details, see our study protocol: 

Effects of a school-based intervention programme on growth, health and well-being of schoolchildren in three African countries: The KaziAfya project