Healthynsect Child Growth and Health Intervention Study

NCT06002620 | Completed

• 1 other identifier: WP2 HEALTHYNSECT
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Status

Keywords

cricket; insect; complementary feeding; gut health; breastmilk intake; 13C sucrose breath test; deuterium oxide; stable isotopes

Outcome Measures

Primary Outcomes (1)

• Stunting (Height/Length for age Z scores)

  Children who are too short for their age according to WHO 2005 growth standards. Length/Height in cm and age in months will be converted to Z scores using WHO Anthro and the values used to categorize growth as per the WHO 2005 standards

  8 months

Secondary Outcomes (2)

• Gut health

  Baseline

• Dietary intake

  Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information

Study Arms (4)

Control arm (CA)

EXPERIMENTAL

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.

Dietary Supplement: CSB+

Enriched nutrition arm (ENA)

EXPERIMENTAL

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.

Dietary Supplement: Enriched nutrition food (CEF)

Nutrition education arm (NEdA)

EXPERIMENTAL

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

Dietary Supplement: CSB+; Behavioral: Nutrition education

Combined Nutrition Education and enriched nutrition (CEdNA)

EXPERIMENTAL

Combines the Cricket Enriched flour(CEF) and Nutrition education

Dietary Supplement: Enriched nutrition food (CEF); Combination Product: Combined nutrition and education

Interventions

CSB+ DIETARY_SUPPLEMENT

standard care

Also known as: Standard care

Control arm (CA); Nutrition education arm (NEdA)

Enriched nutrition food (CEF) DIETARY_SUPPLEMENT

enriched cricket flour at 20%

Combined Nutrition Education and enriched nutrition (CEdNA); Enriched nutrition arm (ENA)

Nutrition education BEHAVIORAL

regular videos, sms reminders and face to face interaction

Nutrition education arm (NEdA)

Combined nutrition and education COMBINATION_PRODUCT

combined enriched cricket flour and nutrition education

Combined Nutrition Education and enriched nutrition (CEdNA)

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 months at the time of enrolment,
• Hemoglobin (Hb) of ≥7 g/dl (not severely anemic) and
• Height for Age (HAZ) ≥-3 Z scores (not severely stunted).

You may not qualify if:

• Those obviously ill and need medical attention who are referred for care as per ministry of health protocol
• Children strictly fed on formula feed with no breast feeding
• Infants whose caregivers do not consent or don't commit to adhere to the feeding regimen prescribed

Sponsors & Collaborators

• University of Copenhagen: lead
• Masinde Muliro University of Science and Technology: collaborator
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

Rwambwa Sub County Hospital

Siaya, Western, 40600, Kenya

Location

Related Publications (1)

• Okeyo NO, Wille CE, Kiiru SM, Sigot AJ, Ng'ang'a J, Kinyuru J, Roos N, Konyole SO. Effect of Edible Cricket Enriched Complementary Porridge and Nutrition Education on Linear Growth of Children 6-14 Months in Siaya County, Kenya: A Randomized 2 x 2 Factorial Trial. Matern Child Nutr. 2026 Mar;22(1):e70156. doi: 10.1111/mcn.70156.

  PMID: 41503750 DERIVED

MeSH Terms

Interventions

Standard of Care; Nutrition Assessment; Educational Status

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health; Socioeconomic Factors; Population Characteristics

Study Officials

• Silvenus O. Konyole, PhD

  Masinde Muliro University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has four arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA). Cricket 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

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 21, 2023
• Study Start: March 9, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: November 26, 2024

Record last verified: 2023-08

Locations

KE (1)