An interventional study of double duty intervention packages in Malnutrition, Malnutrition, Child and Obesity, sponsored by Debre Berhan University. Active, not recruiting at 2 sites in Ethiopia. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Debre Berhan University · Not applicable, Interventional, and Prevention
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.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 456 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Debre Berhan University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Will be provided an intervention.
Behavioral: double duty intervention packages
Will not be provided the intervention.
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.
Proportion of Double burden of malnutrition
Number of Mother of children who received double-duty interventions to reduce the DBM of children
Time frame: 10 months
Proportion of dietary diversity score
Number of Mother of children who received double-duty interventions to improve the dietary diversity score of children.
Time frame: 10 months
Proportion of low frequency of morbidity
Number of Mother of children who received double-duty interventions on the frequency of morbidity in children.
Time frame: 10 months
Proportions of mothers with good maternal nutritional status
Proportions of mothers with good maternal nutritional status through questionnaire
Time frame: 10 months
Plan to share: No — This is a continued project.
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Apr 2024, 12 months.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 12 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Debre Berhan University