Local Dishes Versus Ready-to-use Therapeutic Foods Management of Severe Acute Malnutrition

NCT06759883 | Completed Phase 2

• 1 other identifier: 062/24L/MSP/DRSP-EN/HRA-MOK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In a context of frequent shortages of ready-to-use therapeutic foods (RUTFs), this study aimed at assessing the effectiveness of the use of local dishes in conjunction with nutritional education for children with severe acute malnutrition (SAM) during the rehabilitation phase. This work is based on a randomized, single-blind study. Children aged between 6 to 59 months, hospitalized for SAM and undergoing treatment during the rehabilitation phase, were included. Randomization was performed by consecutive inclusion based on:

• Even numbers (control group under RUTFS) and
• Odd numbers (intervention group with local dishes).

Conditions

Effect of Food; Malnourished Children

Keywords

Efficacy; Local dishes; Severe acute malnutrition; Rehabilitation phase

Outcome Measures

Primary Outcomes (1)

• Correlation between the number of grams (g) of weight gain and the treatment option used

  Describe the difference observed between the control and intervention groups in terms of weight gain at the end of hospitalization.

  From enrolment to the end of treatment up to 12 Weeks

Secondary Outcomes (1)

• Correlation between number of hospital days (days) and therapeutic option used

  From enrolment to the end of treatment up to 12 Weeks

Other Outcomes (2)

• Correlation between patient outcome relapse and treatment option used in both groups at the end of the study.

  From enrolment to the end of treatment up to 12 Weeks

• Correlation between patient outcome deaths and treatment option used in both groups at the end of the study.

  From enrolment to the end of treatment up to 12 Weeks

Study Arms (2)

Ready-to-use therapeutic foods

NO INTERVENTION

Control group on ready-to-use therapeutic foods

Local Dishes

EXPERIMENTAL

Intervention group with local dishes

Combination Product: local dishes using the my plate concept

Interventions

local dishes using the my plate concept COMBINATION_PRODUCT

The intervention in this study consists of replacing the ready-to-use therapeutic foods prescribed in phase 2 of the management of acute severe malnutrition with balanced local dishes.

Also known as: well-balanced local dishes

Local Dishes

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients aged between 6 and 59 months
• with severe acute malnutrition undergoing treatment in the rehabilitation phase,
• whose parents or guardians had provided consent by signing the consent form,

You may not qualify if:

• Patients suffering from identified chronic conditions such as HIV/AIDS, tuberculosis, heart disease,

Sponsors & Collaborators

• University of Garoua: lead

Study Sites (1)

Faculty of Medicine and Biomedical Science

Garoua, North Region, 317, Cameroon

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Suzanne Sap, Pediatrician

  Faculty of Medicine and Biomedical Sciences University of University of Yaoundé

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were assigned an order number based on their arrival. Those with an even number were placed in the control group (under ECDT) following the national protocol, while those with an odd number were placed in the experimental group (using local dishes with nutritional education).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, single-blind study

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 6, 2025
• Study Start: February 29, 2024
• Primary Completion: March 30, 2024
• Study Completion: April 25, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Unending Beginning 6month after publication
• Access Criteria: After publication

Locations

CA (1)