Healthynsect Child Growth and Health Intervention Study (HEALTHYNSECT)

University of Copenhagen

Status: Completed

Conditions: Nutrition Status

Treatments: Dietary Supplement: Enriched nutrition food (CEF); Combination Product: Combined nutrition and education; Behavioral: Nutrition education; Dietary Supplement: CSB+

Study type: Interventional

Funder types: Other

Identifiers

NCT06002620

WP2 HEALTHYNSECT

Details and patient eligibility

About

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.

Full description

Malnutrition in all its forms is still prevalent in resource limited settings driven by low diet quality, food preparation and feeding practices including hygiene. Untreated early childhood malnutrition deprives the child from living to full potential, by increasing susceptibility to childhood infections and is life threatening. Insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Crickets positively support growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Single nutrition interventions are confirmed to be less effective in reducing malnutrition and stunting in particular, with a combination of nutrition-specific and nutrition-sensitive interventions yielding better outcome. In spite of recognizing 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 reducing stunting amongst infants and young children. This study aims to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting status) and gut health in rural Kenya; Alego Usonga Sub-County in Siaya County. The study is based on a 2x2 factorial design among infants aged 6 months and target to assess the main and combined effect of the two interventions (nutrition education and cricket enriched porridge) on the infant and young child's stunting and gut health. The study has four arms namely: Control arm (CA) where the study participants receive the standard care comprising of the supercereal Corn Soy Blend Plus (CSB+) in amounts adjusted for age, Enriched nutrition arm (ENA) where they receive the improved complementary food enriched with cricket and optimized for all the benefits of the cricket in amounts adjusted for age, Nutrition education arm (NEdA) where they receive nutrition education and a Combined Nutrition Education and enriched nutrition (CEdNA). The required sample size (based on the following parameters: Number of groups: = 4, effect size = 0.2, significance level = 0.05, power of test = 80%) is 70 study participants per study arm yielding a total of 280.

Enrollment: 284 patients

Sex: All

Ages: 6 to 7 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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284 participants in 4 patient groups

Control arm (CA)

Experimental group

Description:

A positive control group using an existing nutritional intervention with the known effect will be adopted, so as to meet ethical practice and be able to determine the effect of our new intervention response on the experimental group. The study will use double blinded approach with the control group receiving standard known flour of the supercereal CSB+ adjusted for ages as follows:6-8 months infants receiving 31g daily,9-11 months receiving 47g and 12-24 months receiving 86g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.

Treatment:

Dietary Supplement: CSB+

Enriched nutrition arm (ENA)

Experimental group

Description:

The study will use a Cricket Enriched flour(CEF) - with 20% cricket (, maize, millet, mineral and vitamin premix with amounts served adjusted to ages as:6-8 months infants receiving 29g daily,9-11 months receiving 44g and 12-24 months receiving 80g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.

Treatment:

Dietary Supplement: Enriched nutrition food (CEF)

Nutrition education arm (NEdA)

Experimental group

Description:

Combines the control and nutrition education where nutrition education comprises of a video, face to face session and SMS reminder in predetermined regular sessions

Treatment:

Dietary Supplement: CSB+

Behavioral: Nutrition education

Combined Nutrition Education and enriched nutrition (CEdNA)

Experimental group

Description:

Combines the Cricket Enriched flour(CEF) and Nutrition education

Treatment:

Combination Product: Combined nutrition and education

Dietary Supplement: Enriched nutrition food (CEF)