Healthynsect Child Growth and Health Intervention Study

NCT ID: NCT06002620

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2024-01-16

Brief Summary

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.

Detailed 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.

Conditions

Nutrition Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control arm (CA)

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.

Group Type: EXPERIMENTAL

CSB+

Intervention Type: DIETARY_SUPPLEMENT

standard care

Enriched nutrition arm (ENA)

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.

Group Type: EXPERIMENTAL

Enriched nutrition food (CEF)

Intervention Type: DIETARY_SUPPLEMENT

enriched cricket flour at 20%

Nutrition education arm (NEdA)

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

Group Type: EXPERIMENTAL

CSB+

Intervention Type: DIETARY_SUPPLEMENT

standard care

Nutrition education

Intervention Type: BEHAVIORAL

regular videos, sms reminders and face to face interaction

Combined Nutrition Education and enriched nutrition (CEdNA)

Combines the Cricket Enriched flour(CEF) and Nutrition education

Group Type: EXPERIMENTAL

Enriched nutrition food (CEF)

Intervention Type: DIETARY_SUPPLEMENT

enriched cricket flour at 20%

Combined nutrition and education

Intervention Type: COMBINATION_PRODUCT

combined enriched cricket flour and nutrition education

Interventions

CSB+

standard care

Intervention Type: DIETARY_SUPPLEMENT

Enriched nutrition food (CEF)

enriched cricket flour at 20%

Intervention Type: DIETARY_SUPPLEMENT

Nutrition education

regular videos, sms reminders and face to face interaction

Intervention Type: BEHAVIORAL

Combined nutrition and education

combined enriched cricket flour and nutrition education

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Standard care

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masinde Muliro University of Science and Technology

UNKNOWN

Sponsor Role: collaborator

Jomo Kenyatta University of Agriculture and Technology

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvenus O. Konyole, PhD

Role: PRINCIPAL_INVESTIGATOR

Masinde Muliro University of Science and Technology

Locations

Rwambwa Sub County Hospital

Siaya, Western, Kenya

Countries

Kenya

Other Identifiers

WP2 HEALTHYNSECT

Identifier Type: -

Identifier Source: org_study_id