Clinical trial NCT05791305: Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years
Official title: Double Duty Interventions and Its Impact on DBM Among Children Under Five Years Ethiopia: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Malnutrition, Child
Obesity
Undernutrition
Thinness
Keywords: Double burden of malnutrition
Double-duty interventions
Children under five years
Undernutrition
Overnutrition
Lead sponsor: Debre Berhan University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 456
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial will be used.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* who attend the intervention

Exclusion Criteria:

* who are not attended the intervention

Primary outcomes:
measure: Proportion of Double burden of malnutrition
timeFrame: 10 months
measure: Proportion of dietary diversity score
timeFrame: 10 months
measure: Proportion of low frequency of morbidity
timeFrame: 10 months
Secondary outcomes:
measure: Proportions of mothers with good maternal nutritional status
timeFrame: 10 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Debre Berhan University
state: Amhara
city: Debre Birhan
country: Ethiopia
facility: Health
state: Amhara
Study officials:
References: