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临床试验/NCT06002620
NCT06002620已完成不适用

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

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2023年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
284
试验地点
1
主要终点
Stunting (Height/Length for age Z scores)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
6 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

Stunting (Height/Length for age Z scores)

时间窗: 8 months

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

次要结局

  • Gut health(Baseline)
  • Dietary intake(Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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