Clinical trial NCT06866626: Impact of Harvest Lentil Vegetable Blend and Nutrition Education on Turkana Children's Health Outcomes
Official title: The Effect of Harvest Lentil Vegetable Blend Combined with a Theory Based Nutrition Education Intervention on Turkana Children's Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Keywords: Complementary feeding
WASH practices
Child undernutrition
nutrition education
Harvest Lentil Vegetable Blend
Supplemental feeding
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Breedlove Foods Inc
First posted: 2025-03-10
Enrollment: 602
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study was to test the effect of an intervention that Integrated supplemental feeding program for children aged 6-59 months with a caregiver intensive nutrition education intervention on the health outcomes of Turkan children aged 6-59 months.

The purpose of this study was fivefold: (i) to assess child nutrition status, food security status, child feeding practices, water, hygiene and sanitation (WASH) practices, and the associated factors in Turkana County, Kenya. (ii) To assess the nutrition knowledge, attitudes, subjective norms, perceived behavioral control, and intentions towards recommended child feeding practices among Turkana caregivers of children aged 6-59 months. (iii) To assess the effect of a theory-based nutrition education intervention on nutrition knowledge, attitudes, subjective norms, perceived behavioral control, and intentions towards recommended child feeding practices among Turkana caregivers of children aged 6-59 months, (iv) to evaluate the effect of a theory-based nutrition education intervention on child feeding practices and WASH practices among Turkana caregivers of children aged 6-59 months, (v) and to assess the effect of consuming Harvest Lentil Vegetable Blend combined with nutrition education intervention on the nutritional status of Turkana children aged 6 -59 months.

In this quasi-experimental study, children in the intervention group received a daily meal of Harvest Lentil Vegetable Blend (6 days/week) for eight weeks and their caregivers' received sessions of nutrition education on infant and young child feeding practices and WASH practices. The participants in the control group were only given one bag of supplemental food on the days of data collection to compensate for their time


Eligibility criteria: Inclusion Criteria:

* Children between 6-59 months
* no known allergy reactions to rice, lentils, carrots and onions
* being a permanent resident of nayada and sopel villages
* willingness to participate in the study

Primary outcomes:
measure: Weight
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
Secondary outcomes:
measure: Height
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Height-for-age z-scores (HAZ)
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Weight-for-age z-scores (WAZ)
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Weight-for-height z scores (WHZ)
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: % of children affected by stunting
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: % of children affected by underweight
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: % of children affected by wasting
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: % of children co-currently affected by wasting and stunting
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Meal Frequency
timeFrame: Baseline, midline ( 4 weeks after baseline assessments) and Endline( 8 weeks after baseline assessments)
measure: Dietary Diversity
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Consumption of animal sources foods (ASFs)
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Acceptable diet score
timeFrame: Baseline, midline ( 4 weeks after baseline assessments) and Endline( 8 weeks after baseline assessments)
measure: WASH Practices
timeFrame: Baseline, midline ( 4 weeks after baseline assessments) and Endline( 8 weeks after baseline assessments)
measure: Caregivers' Knowledge on Infant and Child Complementary Feeding Practices
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Caregivers' attitudes towards child feeding practices
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Caregivers perceived social support (subjective norms)
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Caregivers perceived behavioral control
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
measure: Caregivers' intentions to practice recommended child feeding practices
timeFrame: Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)
Other outcomes:
Locations:
city: Sopel Village
country: Kenya
facility: Community Building
state: Turkana
Study officials:
References: