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The impact of diverse complementary foods on improving children's nutrition in Makueni County, Kenya

Effectiveness of diversified complementary food on diet quality and nutritional status among children 6-18 months old: A cluster randomized controlled trial in Makueni County, Kenya

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12736779
Enrollment
240
Registered
2025-03-24
Start date
2025-03-26
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of malnutrition in 6-24 month-old children Nutritional, Metabolic, Endocrine

Interventions

This is a cluster randomized, community-based controlled trial, which tests the effectiveness of a diversified complementary food intervention on diet quality and nutritional status of young children.

Sponsors

Kenyatta University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 18 Months

Inclusion criteria

Inclusion criteria: 1. Aged 6-18 months 2. Living within the catchment area 3. Lived in the study area for 6 months before the trial 4. Caregiver able and willing to participate in both clinic and home visits 5. Written informed consent given by parent/caregiver

Exclusion criteria

Exclusion criteria: 1. Severe acute malnutrition; measured as mid-upper arm circumference (MUAC) < 115 mm or weight-for-length z-score (WLZ) < -3 or bilateral pitting oedema 2. Known critical or chronic condition which may affect the nutrition status of the child 3. Participation in another study or program which impacts this study or previously enrolled in this study 4. Family plans to move away from the catchment area in the next 6 months

Design outcomes

Primary

MeasureTime frame
The number of food groups consumed measured using the Minimum Dietary Diversity (MDD) questionnaire at baseline, 1, 2, 3, 4, 5, and 6 months

Secondary

MeasureTime frame
1. Proportion meeting minimum dietary diversity score measured using the MDD questionnaire at baseline, 1, 2, 3, 4, 5, and 6 months 2. Proportion meeting minimum acceptable diet measured using the MDD questionnaire + minimum meal/milk frequency at baseline, 1, 2, 3, 4, 5, and 6 months 3. Weight gain (g) measured using a standard paediatric weighing scale to the nearest 100 g at baseline, 1, 2, 3, 4, 5, and 6 months 4. Mid-upper arm circumference (cm) (MUAC) measured using a non-elastic MUAC tape at baseline, 1, 2, 3, 4, 5, and 6 months 5. Length (cm) measured using a Seca length board to the nearest 0.1 cm at baseline, 1, 2, 3, 4, 5, and 6 months 6. Length-for-age z-score calculated using AnthroPlus software at baseline, 1, 2, 3, 4, 5, and 6 months 7. Weight-for-length z-score calculated using AnthroPlus software at baseline, 1, 2, 3, 4, 5, and 6 months 8. Weight-for-age z-score calculated using AnthroPlus software at baseline, 1, 2, 3, 4, 5, and 6 months 9. Body composition (fat-free mass (kg), fat mass (kg), fat-free mass index (kg/cm2), fat mass index (kg/cm2)) measured using bioelectrical impedance analysis at baseline and 6 months 10. Haemoglobin (g/L) measured using Hemocue at baseline and 6 months 11. Inflammation-corrected serum ferritin (ug/L) measured using high throughput ELISA at baseline and 6 months 12. Serum soluble transferrin receptor (mg/L) measured using high throughput ELISA at baseline and 6 months 13. Serum C-reactive protein (mg/L) measured using high throughput ELISA at baseline and 6 months 14. Serum alpha-1-acid glycoprotein (g/L) measured using high throughput ELISA at baseline and 6 months 15. Inflammation-corrected retinol-binding protein measured using high throughput ELISA at baseline and 6 months 16. Insulin-like growth factor-1 measured using Cobas instrument at baseline and 6 months 17. Adverse events measured using study records at 1, 2, 3, 4, 5, and 6 months 18. Care-giver reported morbidity measured using caregiver recall (the l

Countries

Kenya

Contacts

Public ContactJuliana Kiio
kiio.juliana@ku.ac.ke+254 725999448

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026