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.