Clinical trial

Effect of Cricket Enriched Porridge and Nutrition Education on Stunting, Gut Health and Breastmilk Intake of Infants and Young Children in Western Kenya

Name
WP2 HEALTHYNSECT
Description
Malnutrition in all its forms is still a problem in resource limited settings including Kenya driven by low diet quality, food preparation and feeding practices including hygiene. Edible insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Despite the nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in the reduction of stunting amongst infants and young children. This study aim to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting) and gut health in Alego Usonga Sub-County in Siaya County of rural western part of Kenya.
Trial arms
Trial start
2023-03-09
Estimated PCD
2024-01-16
Trial end
2024-01-16
Status
Recruiting
Treatment
CSB+
standard care
Arms:
Control arm (CA), Nutrition education arm (NEdA)
Other names:
Standard care
Enriched nutrition food (CEF)
enriched cricket flour at 20%
Arms:
Combined Nutrition Education and enriched nutrition (CEdNA), Enriched nutrition arm (ENA)
Nutrition education
regular videos, sms reminders and face to face interaction
Arms:
Nutrition education arm (NEdA)
Combined nutrition and education
combined enriched cricket flour and nutrition education
Arms:
Combined Nutrition Education and enriched nutrition (CEdNA)
Size
280
Primary endpoint
Stunting (Height/Length for age Z scores)
8 months
Eligibility criteria
Inclusion Criteria: 1. Aged 6 months at the time of enrolment, 2. Hemoglobin (Hb) of ≥7 g/dl (not severely anemic) and 3. Height for Age (HAZ) ≥-3 Z scores (not severely stunted). Exclusion Criteria: 1. Those obviously ill and need medical attention who are referred for care as per ministry of health protocol 2. Children strictly fed on formula feed with no breast feeding 3. Infants whose caregivers do not consent or don't commit to adhere to the feeding regimen prescribed
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The study has four study arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA).\n\nCricket Enriched flour(CEF) - with cricket, maize, millet, mineral and vitamin premix Corn-Soy Blend plus(CSB+) - with mineral and vitamin premix Nutrition Education- with video, face to face session and SMS reminder', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Stratified by sex, randomization was done by a team not participating in the study implementation and the randomization scheme sent directly to the assigned distribution staff The products under investigation are packed in similar containers differentiated by a code number only known to the distribution staff who is equally blinded of the products contents.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}
Updated at
2023-08-21

1 organization

1 product

1 indication