Clinical trial NCT06759883: Local Dishes Versus Ready-to-use Therapeutic Foods Management of Severe Acute Malnutrition
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Effect of Food
Malnourished Children
Keywords: Efficacy
Local dishes
Severe acute malnutrition
Rehabilitation phase
Lead sponsor: University of Garoua
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind study
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Correlation between the number of grams (g) of weight gain and the treatment option used
timeFrame: From enrolment to the end of treatment up to 12 Weeks
Secondary outcomes:
measure: Correlation between number of hospital days (days) and therapeutic option used
timeFrame: From enrolment to the end of treatment up to 12 Weeks
Other outcomes:
measure: Correlation between patient outcome relapse and treatment option used in both groups at the end of the study.
timeFrame: From enrolment to the end of treatment up to 12 Weeks
measure: Correlation between patient outcome deaths and treatment option used in both groups at the end of the study.
timeFrame: From enrolment to the end of treatment up to 12 Weeks
Locations:
city: Garoua
country: Cameroon
facility: Faculty of Medicine and Biomedical Science
state: North
Study officials:
affiliation: Faculty of Medicine and Biomedical Sciences University of University of Yaoundé
name: Suzanne Sap, Pediatrician
role: STUDY_DIRECTOR
References: