NCT06866626

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 25, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

Complementary feedingWASH practicesChild undernutritionnutrition educationHarvest Lentil Vegetable BlendSupplemental feeding

Outcome Measures

Primary Outcomes (1)

  • Weight

    Child's weight measurements were taken using an electronic weighing scale (ROTLIN) and recorded to the nearest 0.01kg. To measure the weight of children less than 24 months, we first weighed their caregivers alone and then weighed caregivers with the child. To gain the true weight of the child we subtracted the combined weight of the child and their caregiver from the caregiver's recorded weight. Children older than 24 months were weighed alone.

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

Secondary Outcomes (18)

  • Height

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

  • Height-for-age z-scores (HAZ)

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

  • Weight-for-age z-scores (WAZ)

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

  • Weight-for-height z scores (WHZ)

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

  • % of children affected by stunting

    Baseline, midline (4 weeks after baseline assessments) and Endline (8 weeks after baseline assessments)

  • +13 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

This arm consisted of 171 children aged 6-59 months and 145 children's caregivers. Children received a daily meal of a supplemental food (Harvest Lentil Vegetable Blend) six days a week for a total of eight weeks. Additionally, their caregivers received a theory-based nutrition education intervention on complementary feeding practices and water, hygiene and sanitation (WASH) practices for eight weeks.

Behavioral: Theory-Based Nutrition Education Intervention to Improve Infant and Young Child Feeding Practices and WASH Practices Among Turkana CaregiversDietary Supplement: Harvest Lentil Vegetable Blend

Control group

NO INTERVENTION

This group consistent of 147 children aged 6-59 months and 139 children's caregivers. Children in the control group were given one bag of Harvest Lentil Vegetable Blend on the days of data collection while their caregivers received no nutrition education intervention.

Interventions

This nutrition education intervention was designed following the DESIGN procedure, informed by the Theory of Planned Behavior, and employed health literacy principles. The nutrition education sessions were held Monday through Saturday for a total of 8 weeks in a community building. This nutrition education intervention had 4 modules, module one covered the recommended breastfeeding practices, including early initiation of breastfeeding, exclusive breastfeeding and continued breastfeeding. The second module was on the young child feeding practices, with a focus on the quality and quantity of the child's meal. The third module entailed WASH practices such as disinfection of drinking water, harms of open defecation, and other personal and household hygiene practices. The fourth module served as a comprehensive review of all previous modules.

Intervention group

Harvest Lentil Vegetable Blend is a dehydrated supplemental food produced from natural ingredients namely, rice, carrots, lentils and onions. This product was prepared by mixing it with water and boiling the mixture for approximately 25-35 minutes to a mid-consistency. In this study we implemented a blanket supplementary feeding program where all the recruited children in the intervention group received a meal of Harvest Lentil Vegetable Blend. The feeding program was on-site, and participating children aged 6-12 months received three-quarters of a cup of the supplemental food, (\~ 52 kcal/d). Children aged 13-23 months received 1 cup of the supplemental food (∼69 kcal/d), whereas children aged 24-59 months received 2 cups of the supplemental food (∼138 kcal/d). The feeding was implemented for 6 days a week (Monday through Saturday) for a total of eight weeks.

Intervention group

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Building

Sopel Village, Turkana County, Kenya

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 10, 2025

Study Start

June 12, 2023

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations