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

Study Overview
=================
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.

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

Conditions
-----------------
Malnutrition, Malnutrition, Child, Obesity, Undernutrition, Thinness

Intervention / Treatment
-----------------
* Behavioral: double duty intervention packages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who attend the intervention Exclusion Criteria: who are not attended the intervention

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial will be used.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Will be provided an intervention. | Behavioral: double duty intervention packages<br>* 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.<br>|
| No Intervention: Controll arm<br>Will not be provided the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Double burden of malnutrition | Number of Mother of children who received double-duty interventions to reduce the DBM of children | 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. | 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. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of mothers with good maternal nutritional status | Proportions of mothers with good maternal nutritional status through questionnaire | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double burden of malnutrition, Double-duty interventions, Children under five years, Undernutrition, Overnutrition