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 Center (ITNC) of the Mokolo Regional hospital Annex in the Far North region of Cameroon. The study population 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, based on the prevalence of severe acute malnutrition (1.6%) among children under 5 years old in the Mayo Tsanaga and Logone et Chari divisions of Cameroon [8] .

Value obtained using the following formula:

$N=\frac{{\left(Z_{\frac{\alpha }{2}}+Z_{\beta }\right)}^2+p\left(1-p\right)\left(r+1\right)}{r{\left(p_0-p_1\right)}^2}$

P₁: Proportion of patients cured on RUTFS;

P₀: proportion of patients cured on local dishes;

N: Target sample size.

Other parameters: Percentage of unexposed people with results: 50%, Exposed/unexposed sample size ratio: 1, Odds ratio: 62, Risk-prevalence ratio: 31, Difference between risk and prevalence: 48. The calculated minimum sample size was 24 participants.

Children aged 6 - 59 months with SAM in the rehabilitation phase were included if their parents or guardians provided written informed consent. This consent was documented before the randomization process to ensure adherence to ethical standards for clinical trials. Children with chronic conditions such as HIV/AIDS, tuberculosis, or heart disease, were excluded. Recruitment was facilitated in collaboration with community health workers.

The study was conducted as a randomized, single-blind trial. After enrollment and baseline assessment, participants were assigned to one of two groups using a computer-generated randomization list. Children assigned an even order number were allocated to the control group (RUTF) following the national protocol, while those assigned an odd order number were allocated to the intervention group (local dishes with nutritional education). Participants were assigned an order number based on their arrival.

Both interventions were provided in neutral code labelled with non-descriptive codes (A or B) to ensure allocation concealment. Health workers responsible for anthropometric and clinical assessments were blinded to treatment allocation. Unblinding was allowed only in the event of a serious adverse event requiring medical intervention. Group codes were disclosed only after completion of data collection and database locking.

Control group: received RUTF according to national guidelines.

Intervention group: The meals consisted of a variety of local dishes. Mothers selected menus typically consumed in their homes, including the five food groups of the “My Plate” concept [9] , prepared them under usual conditions, and then fed their children according to their appetite. Nutrition education sessions were conducted with caregivers covering malnutrition awareness, food groups, child weaning and practical cooking workshops.

Follow-up was divided into a hospital phase (3 days) and a community phase for 2 weeks with daily monitoring which was equivalent to the time need to feed him according to his clinical progress.

Physical examination: For the child’s physical examination, the investigator used WHO Z-score curves, vital sign monitoring equipment, a SECA electronic scale with a 150 kg capacity and ±100 g precision, an infantometer, and a pediatric MUAC tape measure from UNICEF.

The data collected were analyzed using IBM SPSS 27 and organized in Microsoft Office Excel 2019. Statistical 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. Matching socio-demographic parameters between the two study groups was challenging, but the groups were compared to eliminate any statistically significant differences that could influence the final results.

The research protocol was submitted to the regional ethics committee and received approval under ethics clearance and, trial registration number. Ethics clearance number 0065/CERH/NO/2024 date: January, 22, 2024. Trial registration number: NCT06759883 (Retrospectively registered) date of registration: Decembre, 29, 2024. Consent to participate was obtained from the parents or legal guardians of all participants (Children). No invasive procedures were performed, and parents were free to decline participation without any impact on their child’s follow-up.

The study involved 30 children aged between 6 to 59 months, with 15 in the intervention group and 15 in the control group. The predominant form of malnutrition was marasmus, accounting for 100% (n = 15) of cases in the intervention group and 80% (n = 12) in the control group, with the remaining 20% (n = 3) presenting marasmic-kwashiorkor. The sex ratio was 0.88 in the intervention group and 1.5 in the control group.

Children aged 6 to 12 months were predominant in the control group (53.3%, n = 8), while those aged 12 to 24 months were predominant in the intervention group (46.7%, n = 7). The mean age was 15.03 ± 7.43 months in the control group and 17.73 ± 7.63 months in the intervention group, with age extremes ranging from 6 to 31 months in both groups ( Table 1 ).

The predominant Z-score on admission was below −3 SD in both groups: 66.7% (n = 10) in the control group and 60% (n = 9) in the intervention group. Gastroenteritis was the most common complication in both groups. None of these differences were statistically significant. However, statistically significant differences (P < 0.05) were observed regarding food groups in household meals, Mid-Upper Arm Circumference (MUAC) at admission, and the age of dietary diversification onset ( Table 1 ).

Regarding the socio-demographic characteristics of the mothers, the average age was 25.46 ± 5.71 years in the control group and 22.99 ± 4.37 years in the intervention group, with extremes ranging from 17 to 33 years in both groups. The majority of mothers in both groups had a primary school education or less. Polygamous marital status was more prevalent in the control group (60%, n = 9), while monogamous marital status was higher in the intervention group (33.3%, n = 6). Household occupations dominated in both groups, representing 46.7% of cases.

Weight gain, expressed in g/kg/day, was 12.98 for the control group and 17.90 for the intervention group ( Table 2 ). In the in-patient setting, the weight curves of both groups overlapped at the start of the transition phase until day 2. This was followed by a lag during the initial days in the community setting, with the control group’s curve being higher, crossing over on day 5. At the start of the second week, the intervention group’s weight curve rose above that of the control group and remained consistently higher in the community setting ( Figure 1 ).

The duration of the rehabilitation phase was longer in the intervention group (12.16 ± 3.06 days) than in the control group (10.35 ± 2.56 days) (P = 0.121).

The mean Mid-Upper Arm Circumference (MUAC) at discharge was greater in the control group (123 mm) than in the intervention group (119.80 mm).

None of the observed differences between the two groups in terms of weight change, length of hospital stays, or MUAC were statistically significant (P > 0.05) ( Table 2 ).

Regarding therapeutic outcomes, no deaths were recorded in either group. The majority of patients were cured: 53.8% (n = 14) in the control group and 46.2% (n = 12) in the intervention group. However, the intervention group showed a higher relapse frequency, with 3 cases compared to 1 in the control group, primarily due to the onset of diarrhea. The difference observed at the end of treatment between the two groups was not statistically significant (P = 0.283) ( Table 3 ).

Most patients in both groups had a Z-score between −2 and −1 at the end of treatment ( Table 4 ). While the difference in this Z-score range was not statistically significant, the difference in the −1 to +1 range was statistically significant (P = 0.042), with a majority in the control group.

Most children were 13 - 24 months old, a critical dietary diversification period. Early or improper feeding, including giving water during breastfeeding, and low maternal education increase malnutrition risk [11] - [14] . Low household socioeconomic status further heightens vulnerability [15] . Marasmus was the predominant malnutrition type, consistent with other Cameroonian studies [16] [17] . Gastroenteritis was the most common complication at admission (40%), higher than reported in Cameroon (34%) and Mali (15%) [16] [18] .

The weight curve for patients receiving Plumpy’Nut or RUTF (Ready-to-Use Therapeutic Food) showed an initial upward trend during the hospital phase, followed by a decline in the community phase by the second week, and a gradual increase by the end of treatment. Weight gain at the end of the study was 12.12 g/kg/day, reflecting the limitations of RUTF. Its administration is typically supervised in hospitals, explaining the initial rapid weight gain. In poorer households, RUTF is often shared among family members, preventing the malnourished child from receiving the recommended amount for optimal weight recovery. Additionally, mothers may not strictly adhere to feeding malnourished children exclusively with RUTF and may supplement with other foods at home.

In contrast, the weight curve for patients receiving local dishes remained stable during the first week, with a gradual increase observed in the second week. By the end of the study, weight gain reached 17.94 g/kg/day, numerically higher than in the control group, though the difference was not statistically significant (P = 0.128). This superior numerical weight gain demonstrates not only the effectiveness of local dishes but also their equivalence to RUTF in managing severe acute malnutrition. These weight gains align with the World Health Organization’s Integrated National Protocol for Acute Malnutrition, which recommends a minimum weight gain of 8g/kg/day [19] . The intervention group’s weight gain is comparable to that reported by Nguefack et al., who observed gains of 15 to 20 g/kg/day with alternative F-75 and F-100 preparations [16] .

The key advantage of using local dishes is the nutritional counselling and support provided to mothers, empowering them with skills in infant nutrition and ensuring sustained weight gain. Initially, weight gain in this group was slow in the hospital setting but improved significantly once at home. This may be due to the hospital being an unfamiliar environment, limiting the mother’s ability to prepare meals as she would at home. With the skills acquired through nutritional education, mothers were able to better implement the “Five Food Groups” concept at home.

Despite the improvements, none of the patients achieved their target weight at discharge. Z-score values at discharge showed a statistically significant predominance in the −1 to +1 Z-score range in the control group, highlighting the faster initial impact of RUTF compared to local meals.

The intervention group required a longer duration of treatment compared to the control group. This result exceeds the findings of Nguefack et al., who reported a treatment duration ranging from 3 to 9 days using therapeutic milk alternatives [16] .

A comparison of the therapeutic outcomes between the two groups revealed no deaths during the study, supporting the comparable efficacy of local dishes in managing malnutrition during the rehabilitation phase. However, the intervention group exhibited a relapse, although the difference between the two groups was not statistically significant. The relapses were primarily attributed to diarrhea, particularly in the intervention group, where mothers prepared the meals, highlighting hygiene concerns in meal preparation. This underscores the need to emphasize hygiene practices during nutritional education, as our results are higher than those reported in previous studies [16] [20] - [22] .

The minimum sample size was 24 but increased to 30 based on patient availability. A single-blind randomization design reduced measurement and experimenter bias. Statistical analyses (Student’s t-test, Chi-square, Fisher’s exact test) showed significant differences in meal composition, timing of dietary diversification, and brachial circumference (P < 0.05), indicating some baseline heterogeneity which was considered in result interpretation.

The observed baseline differences (MUAC, household food groups, age of complementary feeding introduction) indicate a non-equivalence between the study groups at the outset. Mid-Upper Arm Circumference (MUAC), as an indicator of nutritional status, is particularly concerning. These pre-existing variables constitute important confounding factors, capable of having modulated or biased the estimation of the intervention’s true effect.

In a context where RUTF shortages frequently disrupt the care of malnourished children, family-prepared meals can serve as a viable alternative, provided they adhere to the WHO-recommended food groups and are combined with nutritional education and support for mothers.

Study Design: Unlike typical single-blind studies where medication is identically packaged, it was not possible to package local meals in the same way as RUTF.

Selection Bias: Randomization did not always ensure equal distribution of characteristics between the two groups, potentially overestimating or underestimating certain trends based on available data.

Economic Constraints: Due to a lack of subsidies, the investigator had to personally contribute to purchasing certain food items to supplement the children’s meals during their hospital stay.