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

Obesity Clinical Trial

— DBM  

Official title:

Double Duty Interventions and Its Impact on DBM Among Children Under Five Years Ethiopia: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791305
• Other study ID #: DBU1112
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Obesity
• Thinness
• Undernutrition

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