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

NCT ID: NCT05791305

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2025-12-30

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.

Conditions

Malnutrition; Malnutrition, Child; Obesity; Undernutrition; Thinness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention arm

Will be provided an intervention.

Group Type: EXPERIMENTAL

double duty intervention packages

Intervention Type: BEHAVIORAL

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.

Controll arm

Will not be provided the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• who attend the intervention

Exclusion Criteria

• who are not attended the intervention

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Debre Berhan University

OTHER

Sponsor Role: lead

Responsible Party

Lemma Getacher

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Debre Berhan University

Addis Ababa, Amhara, Ethiopia

Site Status: RECRUITING

Health

Debre Berhan, Amhara, Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Facility Contacts

Lemma Mr. Getacher, MPH

Role: primary

lemmagetacher@dbu.edu.et

+251921137096

Lemma Getacher, MPH

Role: backup

lemmagetacher@gmail.com

+251921137096

Lemma Getacher

Role: primary

lemmagetacher@gmail.com

+251921137096

Other Identifiers

DBU1112

Identifier Type: -

Identifier Source: org_study_id