NCT05791305

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

March 6, 2023

Last Update Submit

August 7, 2024

Conditions

Keywords

Double burden of malnutritionDouble-duty interventionsChildren under five yearsUndernutritionOvernutrition

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Proportions of mothers with good maternal nutritional status

    10 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Will be provided an intervention.

Behavioral: double duty intervention packages

Controll arm

NO INTERVENTION

Will not be provided the intervention.

Interventions

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.

Intervention arm

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • who attend the intervention

You may not qualify if:

  • who are not attended the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Debre Berhan University

Addis Ababa, Amhara, 445, Ethiopia

RECRUITING

Health

Debre Berhan, Amhara, 445, Ethiopia

RECRUITING

MeSH Terms

Conditions

MalnutritionChild Nutrition DisordersObesityThinnessOvernutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOverweightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 30, 2023

Study Start

April 10, 2023

Primary Completion

April 30, 2024

Study Completion

December 30, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

This is a continued project.

Locations