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Recruiting NCT05791305

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

No phase Interventional Malnutrition Malnutrition, Child Obesity Undernutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: double duty intervention packages.
Who it may be relevant to
Registry conditions: Malnutrition, Malnutrition, Child, Obesity, Undernutrition. Basic parameters: 2 years — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ethiopia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 inter

Primary outcome measures

  • Proportion of Double burden of malnutrition [Time frame: 10 months]
  • Proportion of dietary diversity score [Time frame: 10 months]
  • Proportion of low frequency of morbidity [Time frame: 10 months]
Secondary outcome measures (1)
  • Proportions of mothers with good maternal nutritional status [Time frame: 10 months]

Eligibility criteria

Inclusion criteria

  • who attend the intervention

Exclusion criteria

  • who are not attended the intervention

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Ethiopia · 2 centers
  • Debre Berhan University — Addis Ababa
  • Health — Debre Berhan

Identifiers

NCT: NCT05791305 · DBU1112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗