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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Malnutrition; Thinness; Malnutrition, Child; Undernutrition
• Intervention / Treatment: Behavioral: double duty intervention packages

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.

• Study Type: Interventional
• Enrollment (Estimated): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Amhara
    • Addis Ababa, Amhara, Ethiopia, 445
      • Recruiting
      • Debre Berhan University
      • Contact: Lemma Mr. Getacher, MPH; Phone Number: +251921137096; Email: lemmagetacher@dbu.edu.et
      • Contact: Lemma Getacher, MPH; Phone Number: +251921137096; Email: lemmagetacher@gmail.com
      • Principal Investigator: Lemma Getacher, MPH
      • Sub-Investigator: Tefera Belachew, PhD
      • Sub-Investigator: Beyene Wondafrash, PhD
    • Debre Birhan, Amhara, Ethiopia, 445
      • Recruiting
      • Health
      • Contact: Lemma Getacher; Phone Number: +251921137096; Email: lemmagetacher@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• who attend the intervention

Exclusion Criteria:

• who are not attended the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Will be provided an 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.
No Intervention: Controll arm; 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

Collaborators and Investigators

• Sponsor: Debre Berhan University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Overnutrition; Undernutrition; Double burden of malnutrition; Double-duty interventions; Children under five years
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Malnutrition; Child Nutrition Disorders; Thinness
• Other Study ID Numbers: DBU1112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a continued project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No