Effect of FoodPhase 2NCT06759883
Local Dishes Versus Ready-to-use Therapeutic Foods Management of Severe Acute Malnutrition
A Phase 2 study testing local dishes using the my plate concept in people with Effect of Food and Malnourished Children, run by University of Garoua at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Effect of Food, Malnourished Children
- What is being tested?
- local dishes using the my plate concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCameroon
- Study dates
- 29 Feb 2024to 25 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Who cannot join
- Patients suffering from identified chronic conditions such as HIV/AIDS, tuberculosis, heart disease,
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Faculty of Medicine and Biomedical Science
Garoua, North Region, 317
About this study
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)
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).
Read the 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
- Being tested
- local dishes using the my plate concept
- Keywords
- Efficacy, Local dishes, Severe acute malnutrition, Rehabilitation phase
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local dishes using the my plate conceptCombination product
Also called well-balanced local dishes
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.
| Study group | Role | What they receive |
|---|---|---|
| Ready-to-use therapeutic foods | No intervention | Control group on ready-to-use therapeutic foods |
| Local Dishes | Experimental | Intervention group with local dishes Receives: Combination Product: local dishes using the my plate concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Describe the difference observed between the control and intervention groups in terms of the number of days spent in hospital.
Measured: From enrolment to the end of treatment up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start29 Feb 2024
- Primary completion30 Mar 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of FoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Garoua
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAMO SELANGAI Hélène, University of Garoua
- Investigators
- Suzanne Sap, Pediatrician, Study director, Faculty of Medicine and Biomedical Sciences University of University of Yaoundé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759883
- Sponsor's protocol ID
- 062/24L/MSP/DRSP-EN/HRA-MOK
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared in the form of a publication in a paediatric journal
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06759883
- Acronym / sponsor ID
- 062/24L/MSP/DRSP-EN/HRA-MOK
- Conditions
- Effect of Food, Malnourished Children
- Keywords
- Efficacy, Local dishes, Severe acute malnutrition, Rehabilitation phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GarouaUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Ready-to-use therapeutic foods | No intervention | –Control group on ready-to-use therapeutic foods |
| Local Dishes | Experimental | Combination Product: local dishes using the my plate conceptIntervention group with local dishes |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (1 listed)
- Patients suffering from identified chronic conditions such as HIV/AIDS, tuberculosis, heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local dishes using the my plate conceptAlso: well-balanced local dishesThe 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. | Combination product | Local Dishes |
Primary outcome
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.
1 secondary outcome
Correlation between number of hospital days (days) and therapeutic option used
Time frame: From enrolment to the end of treatment up to 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Yes. The data will be shared in the form of a publication in a paediatric journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Sap, Pediatrician study director
Faculty of Medicine and Biomedical Sciences University of University of Yaoundé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing local dishes using the my plate concept in people with Effect of Food and Malnourished Children, run by University of Garoua at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.