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

NCT ID: NCT06759883

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-04-25

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).

Detailed Description

The aim of this study was to evaluate the effectiveness of using local dishes combined with nutritional education in children with severe acute malnutrition (SAM) during the rehabilitation phase. Specifically, the aim was to compare the evolution of clinical parameters (weight, mid-upper arm circumference, length of hospital stay) during treatment, determine the effectiveness of using local dishes combined with nutritional education in the management of SAM, and assess the outcomes of the treated children. This was a randomized, single-blind study conducted over an 11-month period spanning from October 2023 to June 2024 at the In house therapeutic nutrition centre (ITNC) of the Mokolo Regional hospital Annex in the Far North region of Cameroon. The population undergoing the study consisted of children aged between 6 to 59 months hospitalized in the ITNC ward for severe acute malnutrition in the rehabilitation phase. The sample size was calculated using Kelsey's formula.

The minimum sample size required was 24 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, were included. Patients suffering from identified chronic conditions such as tuberculosis, heart disease, etc., were excluded. Patient recruitment was conducted in collaboration with community workers, who facilitated communication with parents or guardians.

During the procedure, discussion sessions were held, focusing primarily on malnutrition awareness, food groups, child weaning, and practical cooking workshops with the parents. Randomization was conducted using the consecutive allocation method based on even and odd numbers. Participants were assigned an order number based on their arrival. Those with an even number were placed in the control group following the national protocol, while those with an odd number were placed in the experimental group (using local dishes with nutritional education).

The meals consisted of a variety of local dishes. Mothers selected menus typically consumed in their homes, prepared them under usual conditions, and then fed their children the quantities accepted by the child. The interviewer ensured that each meal was balanced and included the five food groups of the "My Plate" concept.

The follow-up of selected patients was divided into a hospital phase lasting 3 days and a community phase, with daily follow-ups conducted at regular intervals.

Data collected was recorded on a survey form. For the child's physical examination, the investigator used WHO Z-score curves, vital sign monitoring equipment, a electronic scale ,a UNICEF infant meter, and a paediatric MUAC tape measure from UNICEF.

The survey form collected data on:

Socio-demographic characteristics of the parents or guardians of the children. Clinical and nutritional characteristics: child's age, sex, breastfeeding method, type of malnutrition, vaccination status, Z-score at admission, mid-upper arm circumference (MUAC) at admission and discharge, duration of the rehabilitation phase, medical complications, and Z-score at discharge.

Monitoring and progress during treatment: vital parameters (temperature, heart rate, pulse), anthropometric data (weight, height, Z-score, blood pressure), clinical parameters, and weight progression.

Therapeutic outcomes: cured, relapse, or death. The data collected were analysed using IBM SPSS 27 and organized in Microsoft Office Excel 2019. Statistics tests used were the chi-square test, Fisher's exact test, and Student's t-test. Categorical variables were described as percentages, proportions, and/or frequencies. For statistical analyses, an α error threshold of 5% was applied, and means were expressed with 95% confidence intervals. P-values < 0.050 were considered statistically significant.

The research protocol was submitted to the regional ethics committee and received approval under ethics clearance number 0065/CERH/NO/2024. Parental consent was obtained prior to inclusion. No invasive procedures were performed, and parents were free to decline participation without any impact on their child's follow-up.

Conditions

Effect of Food; Malnourished Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ready-to-use therapeutic foods

Control group on ready-to-use therapeutic foods

Group Type: NO_INTERVENTION

No interventions assigned to this group

Local Dishes

Intervention group with local dishes

Group Type: EXPERIMENTAL

local dishes using the my plate concept

Intervention Type: 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.

Interventions

local dishes using the my plate concept

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

well-balanced local dishes

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Garoua

OTHER

Sponsor Role: lead

Responsible Party

KAMO SELANGAI Hélène

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Sap, Pediatrician

Role: STUDY_DIRECTOR

Faculty of Medicine and Biomedical Sciences University of University of Yaoundé

Locations

Faculty of Medicine and Biomedical Science

Garoua, North Region, Cameroon

Countries

Cameroon

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

062/24L/MSP/DRSP-EN/HRA-MOK

Identifier Type: -

Identifier Source: org_study_id