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Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition (ACFPsCF)

Primary Purpose

Feeding Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Complementary feeding counseling
Sponsored by
Bahir Dar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Feeding Behavior focused on measuring CF Counseling, ACFPs, Child Undernutrition

Eligibility Criteria

6 Months - 15 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mother-child pairs, whose children age is 6 months. Mother-child pairs who reside in the study area for at least 6 months before the survey Mother-child pairs who have no intention of leaving the study area during the intervention period. Exclusion Criteria: Mothers with severe mental illness or unable to communicate (e.g. deaf). Mother-child pairs with severe congenital malformations of their children.

Sites / Locations

  • Bahir Dar UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Complementary Feeding Counseling

Routine Complementary Feeding Counseling

Arm Description

Complementary feeding counseling to the mother-child pairs, in the intervention clusters, will be given by trained women development army (WDA) team leaders. The intervention process will have two components; training of WDA leaders, and counseling of mothers. Counselors' training will be given centrally by the principal investigator. During counseling, WDA leaders will use a counseling guide, which is prepared in Amharic, the local and the national language. The counseling guide contains seven key messages; complementary feeding: at 6 months, from 6-8 months, from 9-11 months, from 12-23 months, hygiene, breast feeding a sick child greater than 6 months, and signs that require mothers' special care of their children. Starting the children's 6 months of age, participants in the intervention group will receive in group counseling at convenient places, and individual counseling at each mother-child pair's home every month for 9 consecutive months (a total of 9 months follow up).

Participants in the control clusters will receive the routine complementary feeding counseling, which is offered by heath extension workers and other health professionals.

Outcomes

Primary Outcome Measures

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 of mothers, 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, and egg &/or flesh food consumptions 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 egg &/or flesh food consumption are full filled. Otherwise, inappropriate if a child feeding practices do not fulfill even one of the components of appropriate complementary feeding practices.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2023
Last Updated
June 10, 2023
Sponsor
Bahir Dar University
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1. Study Identification

Unique Protocol Identification Number
NCT05871346
Brief Title
Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition
Acronym
ACFPsCF
Official Title
Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition in West Gojjam Zone, Northwest Ethiopia: Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
March 9, 2024 (Anticipated)
Study Completion Date
March 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahir Dar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior
Keywords
CF Counseling, ACFPs, Child Undernutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
894 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complementary Feeding Counseling
Arm Type
Experimental
Arm Description
Complementary feeding counseling to the mother-child pairs, in the intervention clusters, will be given by trained women development army (WDA) team leaders. The intervention process will have two components; training of WDA leaders, and counseling of mothers. Counselors' training will be given centrally by the principal investigator. During counseling, WDA leaders will use a counseling guide, which is prepared in Amharic, the local and the national language. The counseling guide contains seven key messages; complementary feeding: at 6 months, from 6-8 months, from 9-11 months, from 12-23 months, hygiene, breast feeding a sick child greater than 6 months, and signs that require mothers' special care of their children. Starting the children's 6 months of age, participants in the intervention group will receive in group counseling at convenient places, and individual counseling at each mother-child pair's home every month for 9 consecutive months (a total of 9 months follow up).
Arm Title
Routine Complementary Feeding Counseling
Arm Type
Experimental
Arm Description
Participants in the control clusters will receive the routine complementary feeding counseling, which is offered by heath extension workers and other health professionals.
Intervention Type
Behavioral
Intervention Name(s)
Complementary feeding counseling
Intervention Description
Complementary Feeding Counseling to Improve Appropriate Complementary Feeding Practices and Reduce Child Undernutrition
Primary Outcome Measure Information:
Title
Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months
Description
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 of mothers, 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, and egg &/or flesh food consumptions 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 egg &/or flesh food consumption are full filled. Otherwise, inappropriate if a child feeding practices do not fulfill even one of the components of appropriate complementary feeding practices.
Time Frame
At base line (from June 9 to August 9/2023), and in 9 months (from March 9 to May 9/2024)
Secondary Outcome Measure Information:
Title
Change from baseline in child nutritional status at 9 months
Description
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.
Time Frame
At base line (from June 9 to August 9/2023), and in 9 months (from March 9 to May 9/2024)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mother-child pairs, whose children age is 6 months. Mother-child pairs who reside in the study area for at least 6 months before the survey Mother-child pairs who have no intention of leaving the study area during the intervention period. Exclusion Criteria: Mothers with severe mental illness or unable to communicate (e.g. deaf). Mother-child pairs with severe congenital malformations of their children.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiferaw Birhanu Aynalem, MSc
Phone
+251-989-298-581
Email
shifebirhanu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiferaw Bi Aynalem, MSc
Organizational Affiliation
Bahir Dar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahir Dar University
City
Bahir Dar
State/Province
Amhara Regional State
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiferaw Bi Aynalem, MSc
Phone
+251-989-298-581
Email
yonishife@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29032617
Citation
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.
Results Reference
result

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Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition

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