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

Sponsor
Debre Berhan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05791305
Collaborator
(none)
456
1
2
8.7
52.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: double duty intervention packages
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
456 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized controlled trial will be used.A randomized controlled trial will be used.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Double Duty Interventions and Its Impact on DBM Among Children Under Five Years Ethiopia: A Cluster Randomized Controlled Trial
Anticipated Study Start Date :
Apr 10, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of Double burden of malnutrition [10 months]

    Number of Mother of children who received double-duty interventions to reduce the DBM of children

  2. Proportion of dietary diversity score [10 months]

    Number of Mother of children who received double-duty interventions to improve the dietary diversity score of children.

  3. Proportion of low frequency of morbidity [10 months]

    Number of Mother of children who received double-duty interventions on the frequency of morbidity in children.

Secondary Outcome Measures

  1. Proportions of mothers with good maternal nutritional status [10 months]

    Proportions of mothers with good maternal nutritional status through questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • who attend the intervention
Exclusion Criteria:
  • who are not attended the intervention

Contacts and Locations

Locations

Site City State Country Postal Code
1 Debre Berhan University Addis Ababa Amhara Ethiopia 445

Sponsors and Collaborators

  • Debre Berhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lemma Getacher, Principal investigator, Debre Berhan University
ClinicalTrials.gov Identifier:
NCT05791305
Other Study ID Numbers:
  • DBU1112
First Posted:
Mar 30, 2023
Last Update Posted:
Mar 30, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lemma Getacher, Principal investigator, Debre Berhan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2023