NCT04504617

Brief Summary

Child undernutrition is a worldwide public health problem that has persisted in African countries. For instance, the most recently reported prevalence rates of stunting (38%), underweight (24%), and wasting (10%) among children under the age of five in Ethiopia is higher than the global prevalence. The causes of undernutrition are classified in the following manner: immediate causes, such as inadequate dietary intakes; underlying causes, such as household food insecurity and inadequate care and feeding practices; and basic causes, which involve the household's inadequate access to education, employment, and income, among others. Evidence has demonstrated that nutrition education interventions (NEI) may influence both underlying and immediate causes of child undernutrition. For instance, nutrition education interventions have the potential of preventing the underlying causes of child undernutrition by improving mothers' knowledge in care and feeding practices, and further improving the quality and quantity of dietary intake, which is considered an immediate cause of child undernutrition. Moreover, nutrition education interventions designed to improve infant and young child feeding (IYCF) practices, such as dietary diversity, frequency, and adequacy, are considered a high impact strategy that may substantially reduce stunting. Preliminary data from Hawassa University (collaborating institution in this project) demonstrated that approximately 86% of the children residing in Arsi Negele, Wondo Genet, and Dale districts in Oromia and Southern Nations, Nationalities and Peoples' (SNNP) regions in Ethiopia do not receive adequate complementary feeding practices. Such lack of optimal complementary feeding practices may compromise a child's growth, development, and survival. Therefore, there is a critical need for improving child complementary feeding practices to promote their well-being and adequate nutritional status. Thus, the main purpose of this study is to improve child feeding practices and related nutritional status by improving the mother's knowledge, attitudes, and practices (KAP) of complementary feeding practices for their children aged six to 23 months in three woredas located in Oromia and SNNP. It is hypothesized that after the NEI mothers will improve their children' dietary diversity, frequency and adequacy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 5, 2020

Last Update Submit

August 5, 2020

Conditions

Keywords

Infant undernutritionComplementary feeding

Outcome Measures

Primary Outcomes (3)

  • Dietary diversity score

    The dietary diversity score will be measured using the population indicator of minimum dietary diversity score for children aged 6 to 23 months designed by The Who. This measurement assess the consumption of seven food groups through seven yes-no questions. The food groups that are assessed are the following: 1) grains, roots and tubers; 2) legumes and nuts; 3) dairy products (milk, yogurt, cheese); 4) flesh foods (meat, fish, poultry, and organ meats); 5) eggs; 6) vitamin A rich fruit and vegetables; and 7) other fruits and vegetables. The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer. The maximum score possible is seven.

    Six weeks

  • Meal frequency

    The meal frequency of children will be measured using a question that forms part of the Infant Young and Child Feeding Practices questionnaire provided by the WHO. This question assess the number of times that a baby had meals or snacks, other than liquids, through a multiple answer questions. The participating mother has the option to select the meal frequency from one to six times. The average meal frequency will be calculated for those breastfed and non-breastfed children.

    Six weeks

  • Acceptable diet score

    This is an indicator that measures the proportion of children aged 6 to 23 months of age who receive the minimum feeding frequency and minimum dietary diversity. The acceptable diet score will be calculated using the proportion of children that meet the minimum dietary diversity and the minimum meal frequency divided by the total number of children. This score will be calculated for breastfed and non-breastfed children.

    Six weeks

Secondary Outcomes (4)

  • Child feeding knowledge score

    six weeks

  • Child feeding maternal attitude score

    six weeks

  • Maternal dietary diversity score

    six weeks

  • Nutritional status

    six weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will consist of six kebeles with a total of 90 pairs of mothers and their children that will receive the nutrition education intervention to enhance complementary feeding practices first. The six lessons will be delivered in a period of 6 weeks. Before the intervention this groups will be assessed with the baseline assessment. After the intervention, this group will be assessed in three time points (post-intervention, follow-up 1 and follow-up 2).

Behavioral: Nutrition education intervention to enhance complementary feeding practices

Delayed Intervention Group

ACTIVE COMPARATOR

This arm will consist of the six kebeles with a total of 90 pairs of mothers and their children that will not receive the intervention immediately. This group will first complete the baseline and the second assessment. After the second assessment, this group will receive the nutrition education intervention to enhance complementary feeding practices. After the intervention, this group will be assessed in two additional time points (post-intervention and follow-up 1).

Behavioral: Nutrition education intervention to enhance complementary feeding practices

Interventions

The intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory. The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol. Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages.

Delayed Intervention GroupIntervention Group

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for at least one year
  • Infants that are within the age of 6 to 23 months at the time of the recruitment
  • Infants that live in households where the mother is permanently present
  • Infants that live in a household where the mother speaks sidamo or oromio.

You may not qualify if:

  • Infants that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for less than one year
  • Infants that are under 6 months or above 23 months of age at the time of the recruitment
  • Infants that live in households where the mother is not present
  • Infants that live in households where the mother does not speak sidamo or oromio
  • Infants that have an illness that require a special nutrition treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawassa University

Awasa, Southern Nations, Nationalities, and Peoples' Region, Ethiopia

Location

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mary W Murimi, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

December 2, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations