Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia

May 7, 2024 updated by: Carol J. Henry, University of Saskatchewan

Evaluation of the Effectiveness of Nutrition Education Intervention Among Rural Mothers on Pulse and Cereal Mix Complementary Food and Nutritional Status of Children Age 6-24 Months in Sidama Zone, Southern Ethiopia

The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Only 9% of the population in Southern Ethiopia consumes pulse and pulse total contribution of the diet is less than 4.9% for women and less than 3.3% for children.Young children are at risk of developing malnutrition because of dietary inadequacy. Educational interventions can improve feeding practices and growth of young children. The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children. Before, at midline and end of the intervention we will assess the KAP of mothers, dietary intake of iron and zinc and nutritional status of young children. The nutrition education intervention will be given for 9 months. Serum ferritin, serum zinc, C-Reactive protein and hemoglobin and dietary intake of iron and zinc of young children will be measured at the beginning and ending of the intervention.

Study Type

Interventional

Enrollment (Actual)

772

Phase

  • Not Applicable

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

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 6-15 months
  • Apparently healthy
  • Being breastfed at time of recruitment
  • The mothers are permanent residents of the kebele

Exclusion Criteria:

  • Infant undergoing treatment with supplemental foods for malnutrition

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Usual education
Households in the control clusters (kebeles) will receive usual nutrition education from Health extension workers, about complementary foods, over 9 months.
Other: enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers
Experimental: Enhanced Education
Additional education sessions from Health extension workers (HEWs) trained on use of pulses for complementary foods (CF). HEWs provide nutrition education programs and counseling about pulse-cereal mix complementary foods, over 9 months.
Other: enhanced education on pulse use in complementary foods
Enhanced Nutrition education with sessions and counseling by health extension workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal knowledge, attitudes and practices towards pulse-cereal mix complementary food
Time Frame: 9 months
Using validated questions on knowledge, attitude and practices
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight for height Z-score of children
Time Frame: 9 months
Change in z-score of measured weight and measured height (length) ratio at 9 months
9 months
Zinc status of children
Time Frame: 9 months
Measurement of serum zinc against WHO standards
9 months
Iron status
Time Frame: 9 months
iron status as determined by serum ferritin corrected for inflammation using markers, whole hemoglobin to define anemia status using WHO standards.
9 months

Collaborators and Investigators

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

Sponsor

University of Saskatchewan

Collaborators

Hawassa University

Investigators

  • Principal Investigator: Carol J Henry, PhD, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 19, 2016

Primary Completion (Actual)

November 22, 2016

Study Completion (Actual)

November 22, 2016

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimated)

December 23, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSE-HEW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only mean (or median) data will be published. If there are correlations or regressions the r or r2 will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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