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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05791305
Other study ID # DBU1112
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2023
Est. completion date December 30, 2025

Study information

Verified date February 2024
Source Debre Berhan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 456
Est. completion date December 30, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 5 Years
Eligibility Inclusion Criteria: - who attend the intervention Exclusion Criteria: - who are not attended the intervention

Study Design


Intervention

Behavioral:
double duty intervention packages
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.

Locations

Country Name City State
Ethiopia Debre Berhan University Addis Ababa Amhara
Ethiopia Health Debre Birhan Amhara

Sponsors (1)

Lead Sponsor Collaborator
Debre Berhan University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Double burden of malnutrition Number of Mother of children who received double-duty interventions to reduce the DBM of children 10 months
Primary Proportion of dietary diversity score Number of Mother of children who received double-duty interventions to improve the dietary diversity score of children. 10 months
Primary Proportion of low frequency of morbidity Number of Mother of children who received double-duty interventions on the frequency of morbidity in children. 10 months
Secondary Proportions of mothers with good maternal nutritional status Proportions of mothers with good maternal nutritional status through questionnaire 10 months
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