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Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years (DBM)

Primary Purpose

Malnutrition, Malnutrition, Child, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
double duty intervention packages
Sponsored by
Debre Berhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Double burden of malnutrition, Double-duty interventions, Children under five years, Undernutrition, Overnutrition

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: who attend the intervention Exclusion Criteria: who are not attended the intervention

Sites / Locations

  • Debre Berhan UniversityRecruiting
  • HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Controll arm

Arm Description

Will be provided an intervention.

Will not be provided the intervention.

Outcomes

Primary Outcome Measures

Proportion of Double burden of malnutrition
Number of Mother of children who received double-duty interventions to reduce the DBM of children
Proportion of dietary diversity score
Number of Mother of children who received double-duty interventions to improve the dietary diversity score of children.
Proportion of low frequency of morbidity
Number of Mother of children who received double-duty interventions on the frequency of morbidity in children.

Secondary Outcome Measures

Proportions of mothers with good maternal nutritional status
Proportions of mothers with good maternal nutritional status through questionnaire

Full Information

First Posted
March 6, 2023
Last Updated
September 6, 2023
Sponsor
Debre Berhan University
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1. Study Identification

Unique Protocol Identification Number
NCT05791305
Brief Title
Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years
Acronym
DBM
Official Title
Double Duty Interventions and Its Impact on DBM Among Children Under Five Years Ethiopia: A Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Debre Berhan University

4. Oversight

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

5. Study Description

Brief Summary
Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.
Detailed Description
Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia. Methods: A cluster randomized controlled trial will be conducted among 456 under-five children (228 for each group) from January 25, 2023 to December 30, 2023. This pilot study will be used a one-year two-arm parallel cluster randomized controlled trial using clusters as a unit of randomization. Expected outcomes: The endpoints expected from this pilot study are decreased double burden of malnutrition, improved minimum dietary diversity score, and decreased frequency of morbidity among children using double-duty interventions in the study area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Malnutrition, Child, Obesity, Undernutrition, Thinness
Keywords
Double burden of malnutrition, Double-duty interventions, Children under five years, Undernutrition, Overnutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial will be used.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Will be provided an intervention.
Arm Title
Controll arm
Arm Type
No Intervention
Arm Description
Will not be provided the intervention.
Intervention Type
Behavioral
Intervention Name(s)
double duty intervention packages
Intervention Description
The intervention employed in this study will serve as double-duty interventions. The WHO policy short report from 2017 and Hawkes et al2020 .'s were amended and used as the basis for the DDIs packages. The main components of the intervention packages are the promotion of a minimum level of dietary diversity, avoiding unwarranted harm from high-energy foods, and controlling market foods from the perspective of the consumer. The following central criteria will be used to evaluate the study's intervention packages.
Primary Outcome Measure Information:
Title
Proportion of Double burden of malnutrition
Description
Number of Mother of children who received double-duty interventions to reduce the DBM of children
Time Frame
10 months
Title
Proportion of dietary diversity score
Description
Number of Mother of children who received double-duty interventions to improve the dietary diversity score of children.
Time Frame
10 months
Title
Proportion of low frequency of morbidity
Description
Number of Mother of children who received double-duty interventions on the frequency of morbidity in children.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Proportions of mothers with good maternal nutritional status
Description
Proportions of mothers with good maternal nutritional status through questionnaire
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who attend the intervention Exclusion Criteria: who are not attended the intervention
Facility Information:
Facility Name
Debre Berhan University
City
Addis Ababa
State/Province
Amhara
ZIP/Postal Code
445
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemma Mr. Getacher, MPH
Phone
+251921137096
Email
lemmagetacher@dbu.edu.et
First Name & Middle Initial & Last Name & Degree
Lemma Getacher, MPH
Phone
+251921137096
Email
lemmagetacher@gmail.com
First Name & Middle Initial & Last Name & Degree
Lemma Getacher, MPH
First Name & Middle Initial & Last Name & Degree
Tefera Belachew, PhD
First Name & Middle Initial & Last Name & Degree
Beyene Wondafrash, PhD
Facility Name
Health
City
Debre Birhan
State/Province
Amhara
ZIP/Postal Code
445
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemma Getacher
Phone
+251921137096
Email
lemmagetacher@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a continued project.

Learn more about this trial

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

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