Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Infants in Southern Ethiopia

August 5, 2020 updated by: Mary Murimi, Texas Tech University

A Theory-based Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Young Children in Southern Ethiopia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Elegibility criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for at least one year, households that have children between 6 and 23 months of age, households where the mother is permanently presents, and households that speak sidamo or oromio.

Exclusion criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for less than one year, households that have children under 6 months or above 23 months of age, households where the mother is not present, and households that do not speak sidamo.

Outcomes of this study are child feeding practices knowledge, attitudes, dietary diversity score, meal frequency score, adequacy diet score, continuing breastfeeding, maternal dietary diversity, and prevalence of stunting, wasting, and underweight.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Southern Nations, Nationalities, And Peoples' Region
      • Awassa, Southern Nations, Nationalities, And Peoples' Region, Ethiopia
        • Hawassa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
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
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.
Active Comparator: Delayed Intervention Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary diversity score
Time Frame: Six weeks
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
Time Frame: Six weeks
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
Time Frame: Six weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child feeding knowledge score
Time Frame: six weeks
The child feeding knowledge score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices. The section of knowledge includes 7 open-ended questions in which the data collector will ask an open-ended question to the mother and the mother will have to provide a short answer in her own words. The knowledge score per participant will be calculated based on the number of correct answers provided and an average score of participants will be calculated.
six weeks
Child feeding maternal attitude score
Time Frame: six weeks
The child feeding maternal attitude score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices. The section of attitudes includes 7 three-point Likert scale questions. These questions will assess self-confidence, perceived benefits and barriers for providing diversity foods, frequently meals, and continued breastfeeding for their children aged 6 to 23 months. Responses will be codified to calculate an attitude score per participant. Responses will be codified in the following way: "no confident", "not good" and "challenging" as one; "ok/so-so", "you're not sure", and so-so as two; and "good" and "not challenging" as three.
six weeks
Maternal dietary diversity score
Time Frame: six weeks
The dietary diversity score will be measured using the Minimum Dietary Diversity for Women (MDD-W). This measurement assess the consumption of 10 food groups through 17 yes-no questions. The food groups that are assessed are the following: 1) grains, white roots, tubers, and plantains; 2) pulses (beans, peas, and lentils); 3) nuts and seeds; 4) dairy; 5) meat, poultry and fish; 6) eggs; 7) dark green leafy vegetables; 8) other vitamin-A rich fruits and vegetables; 9) other vegetables; and 10) other foods. 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 ten.
six weeks
Nutritional status
Time Frame: six weeks
WHO Anthro software will be utilized to calculate weight-for-height z-score (WHZ), height-for-age z-score (HAZ), and weight-for-age z-score (WAZ). Then those children that have a -2 standard deviation in their WHZ, HAZ, and WAZ will be categorized as having wasting, stunting, or underweight. The prevalence of these nutritional status categories will be compared before and after the intervention.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kansas State University
Hawassa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary W Murimi, PhD, Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2019-664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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