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

December 29, 2024 updated by: KAMO SELANGAI Hélène, University of Garoua

Local Dishes Versus Ready-to-use Therapeutic Foods in the Management of Severe Acute Malnutrition During the Rehabilitation Phase: a Randomized, Single-blind Study at the Regional Hospital Annex of Mokolo (Cameroon)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • North
      • Garoua, North, Cameroon, 317
        • Faculty of Medicine and Biomedical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Ready-to-use therapeutic foods
Control group on ready-to-use therapeutic foods
Experimental: Local Dishes
Intervention group with local dishes
Combination product: 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.
Other Names:
  • well-balanced local dishes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between the number of grams (g) of weight gain and the treatment option used
Time Frame: From enrolment to the end of treatment up to 12 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between number of hospital days (days) and therapeutic option used
Time Frame: From enrolment to the end of treatment up to 12 Weeks
Describe the difference observed between the control and intervention groups in terms of the number of days spent in hospital.
From enrolment to the end of treatment up to 12 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between patient outcome relapse and treatment option used in both groups at the end of the study.
Time Frame: From enrolment to the end of treatment up to 12 Weeks
Describe the outcome of participants in the two study groups With regard to relapse
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.
Time Frame: From enrolment to the end of treatment up to 12 Weeks
Describe the outcome of participants in the two study groups With regard to deaths
From enrolment to the end of treatment up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Garoua

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Suzanne Sap, Pediatrician, Faculty of Medicine and Biomedical Sciences University of University of Yaoundé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 062/24L/MSP/DRSP-EN/HRA-MOK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared in the form of a publication in a paediatric journal

IPD Sharing Time Frame

Unending Beginning 6month after publication

IPD Sharing Access Criteria

After publication

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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