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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05871346
Other study ID # adenek2195
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 9, 2023
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Bahir Dar University
Contact Shiferaw Birhanu Aynalem, MSc
Phone +251-989-298-581
Email shifebirhanu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Appropriate complementary feeding practices as per the world health organization recommendations is a window of opportunity to promote health and prevent acute and chronic under nutrition (stunting, wasting & underweight). Globally, the burden of under nutrition remains unacceptably high, and the progress of under nutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child under nutrition is a major public health problem.


Description:

Appropriate nutrition during the first 1000 days of life lays the foundation for a child's health and well-being. Introduction of complementary foods within 6-8 months of age and step-wise increase of diversified plant and animal-based diets is necessary, for which exclusive breast milk is no longer enough to meet the nutritional needs. Appropriate complementary feeding practices as per the world health organization recommendations is a window of opportunity to promote health and prevent acute and chronic under nutrition (stunting, wasting & underweight). Globally, the burden of under nutrition remains unacceptably high, and the progress of under nutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child under nutrition is a major public health problem. This study aims to determine the effects of complementary feeding counseling on appropriate complementary feeding practices and child under nutrition through a community based randomized controlled trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 802
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 21 Months
Eligibility Inclusion Criteria: 1. Mother-child pairs, whose children age is 6 months. 2. Mother-child pairs who reside in the study area for at least 6 months before the survey 3. Mother-child pairs who have no intention of leaving the study area during the intervention period. Exclusion Criteria: 1. Mothers with severe mental illness or unable to communicate (e.g. deaf). 2. Mother-child pairs with severe congenital malformations of their children.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Complementary feeding counseling
Complementary Feeding Counseling to Improve Appropriate Complementary Feeding Practices and Reduce Child Undernutrition

Locations

Country Name City State
Ethiopia Bahir Dar University Bahir Dar Amhara Regional State

Sponsors (1)

Lead Sponsor Collaborator
Bahir Dar University

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

Michaelsen KF, Grummer-Strawn L, Begin F. Emerging issues in complementary feeding: Global aspects. Matern Child Nutr. 2017 Oct;13 Suppl 2(Suppl 2):e12444. doi: 10.1111/mcn.12444. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months. Questions related to complementary feeding practices will be used to measure the complementary feeding practices of mothers for their children (Appropriate/Inappropriate). To measure appropriate complementary feeding practices, based on the world health organization recommendations for infant and young child feeding practices, continue of breast feeding, starting of solid, semi-solid or soft foods at 6 months of age, the eight indicators used to calculate the dietary diversity, and the meal frequency will be asked. Minimum dietary diversity, minimum meal frequency, and minimum acceptable diet will be determined. Appropriate complementary feeding practices is defined if the four indicators: timely introduction of complementary foods, minimum dietary diversity, minimum meal frequency, and minimum acceptable diet for age are full filled. Otherwise, inappropriate if a child feeding practices do not fulfill even one of the components of appropriate complementary feeding practices. At base line (from June 9 to December 30/2023), and in 9 months (from September 30 to December 30/2024)
Secondary Change from baseline in child nutritional status at 9 months The child nutritional status (Under nutrition/ No Under nutrition) will be determined by measuring the length, weight, and calculating the child's age. Length will be measured using a calibrated length board to the nearest 1mm (0.1cm). Weight will be measured using mechanical hanging scale with weighing pants to the nearest 10g at the time of enrolment and 100g at end-line measurements. Before weighing the child, the weight scale will be hung securely and set to zero. Child's age will be calculated by subtracting the child's date of birth from the date of baseline data collection. Undernutrition will be defined if a child is wasted, or underweight, or stunted. The child is wasted: when the weight-for-length-Z score (WLZ) is <-2 standard deviations; Underweight: when Weight-for-age Z score (WAZ) is <-2 standard deviations, and Stunted: when length-for-age Z score (LAZ) is <-2 standard deviations. (from June 9 to December 30/2023), and in 9 months (from September 30 to December 30/2024)
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