School-based physical activity and multi-micronutrient supplementation to increase health and improve health-related behaviours Other School-based physical activity and multi-micronutrient supplementation to increase health and improve health-related behaviours
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 la | — |
Countries
Côte d'Ivoire, South Africa, Tanzania