Impact of an Oral Nutrition Supplement on the Nutritional Status of Stunted and At-Risk of Stunting Children: A Community-Based Intervention Trial
, Hamid Jan Jan Mohamed 1,*, Amal K. Mitra 2, Hans Van Rostenberghe 3,4, Siti Nur Haidar Hazlan 3 and Ilse Khouw 5Round 1
Reviewer 1 Report
Comments and Suggestions for AuthorsThis is an important contribution, but unfortunately only is a pilot study, suggesting further studies. It's partly of minor presentation level, and requires substantial improvements.
Major:
Statistics: There is no power analysis of trial
There is no justification (test of normal distribution) to show data as means and SD and to use parametric tests. Some data are obviously not normally distributed (thiamin pre/post).
The flowchart (Fig. 1 ) is unclear. Were all children included by meeting the inclusion criterium of stunting/at risk, or - if not - how ere they selected?
L. 228ff: this isn't precise enough. What established methods/questionnairees were used. Additionally, specify, please! What was personally, what was via telephone.
Results:
A general question is, whether the diets were kept constant during intervention.
L. 291: Flowchart is unclear. There is a great number of individuals without intervention. What is the reason of allocation to intervention? Was there a randomization protocol. The correct word is flowchart rather than >flowchat<. It's not clear, what patient numbers and what line numbers are. Please clarify. Provide reasons for excluded/data cleaning.
Explain the reason, why there are two thirds male children? Age: provide range! Is it equally distributed. In the preterm infants/children: provide gestational age at birth. Don't include these into normal calculations, if below 34w GA. Show separate.
Table 1:
Explain, why only islamic children are included. More important, therre are only 52% malayish thenicity. Provide a differentiated picture of participants.
Approximate Monthly Household Food: Specify more intencely, please. How is this distributed among the income groups?
Table 2:
Include all abbreviations in in the legend. Improve table design with lines.
It is generally not adequate, as there are no comparative data of a control group nor any other reference control data for normal development. That children grow, and that there are significant differences between T0 and T180 is to be expected. There is no evidence shown that growth has improved to any non-interventional group.
L. 355ff: I don't see any improvement in BMI here.
L.364ff: Show data in a graph. Additionally, provide individual data points in an online supplement to show whether individual effects are consistent. Moreover, correlate effects with the degree of stunting. Same for WAZ and HAZ.
Table 4:
Total energy: How was this calculated I came to different numbers.: Explain, why thiamine decreased by nearly 50%, while others increased.
What is missing is adequate intake/RDA values for these children, and information on energy etc per kg body weight.
L. 463f: provide alternatives to ONS intervention, as regular infant birth and development is regularly based on adequate maternal nutrition and breast feeding. There is no adequate mentioning, what the fundamental feeding problem in women and children is.
L. 480: define the kind of counseling, as it obviously wasn't successful.
L 527: This doesn't match with the information of 12-36months of age range in abstract and methods.
L. 529: Plot initial age vs. effects.
L. 548: choline as a critical nutrient in children is missing.
L. 570f: this reasoning doesn't fit. Where all stunted or at risk children included? If yes, please clearly define this as an inclusion parameter. If there are children meeting these parameters other than the intervention group: why weren't they used as a control?
References on the normal course of scores in this population are missing for comparison in the discussion.
L. 589ff: The conclusions are too firm, when taking into account that concepts of nutrition improvements in the mothers, a power analysis and valid control data are mission. This should be emphysized for future studies and concepts of improvement.
L. 609: Data primarily support calls for adequate nutrition programs for women, an analysis of basal reasons for stunting in spite of socio-economic wellfare, and randomized trials rather than only ONSs.
Minor:
L. 26f: Adjust diction
L. 29: adjust diction like: The age of children was +/- ... (mean +/- standard devation. Include full range as well.
Generally, as children from 12-36 months were included
L 35: unclear, what the authors mean.
L. 69: Explain to the reader, why an increase from 17.7 to 21.2% is 20%. Change diction to 1,2fold increase.
L. 205: Include adequate abbreviations: T90, T180.
L210+L219: 10% difference for a measurement questions the study methods/equipment. Please clarify.
L 255f; Change position of parenthees.
L. 269: subject >was< considered compliant. Provide the percentage of compliant participants.
L. 275: specify >SharePoint<!
L. 281: Include location and country of company.
L. 285f: include units for individual nutrients.
L. 312: enrolled or allocated as in flow chart?
Table 1: Kindergarden, rather than kindergarten.
L333: were rather than are.
L. 392: McNemar test is not defined in Methods.
L. 403f: sentence belongs to the discussion.
Table 4, thiamine: baseline value surely isn't normally distributed, and questions that nutrition was constant during intervention.
L, 436: include all abbreviations here.
L. 494: define growth milk.
L. 508: typing error: > Fconfirmed<
L511f: this isn't only true for developing countries!
Author Response
Please find attached.
Author Response File: 
Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for AuthorsThe manuscript provides the first community-based evidence in Malaysia demonstrating that a 180-day intervention with a nutrient-dense oral nutritional supplement can effectively reverse growth faltering in children aged 12–36 months. This study addresses a critical public health crisis in Malaysia, where stunting rates have paradoxically increased despite the country's economic development.
Several major issues must be addressed before the article can be considered for publication in a high-impact journal
.
In the Abstract please double check the mention of compliance monitoring needs revision. The manuscript reports a mean compliance rate of 7.4 +/- 6.70, which is likely a typographical error given the significant positive outcomes of the trial. If this value is indeed correct, it would fundamentally undermine the feasibility and validity of the intervention.
The Introduction should briefly discussing specific cultural or dietary habits in Kelantan that contribute to its status as the state with the highest stunting burden in Malaysia (28.8%).
In the material and methdos the authors must explicitly define the "community-based" aspect and detail the criteria used to select the 50 nurseries involved.
The authors should also explain how potential "social desirability bias"—where parents might over-report supplement intake—was mitigated beyond the collection of empty sachets.
As mentioned above in the abstract please double check the reported mean compliance rate of 7.4 ± 6.70 because it appears to be a major factual error, because this value contradicts the definition of a "compliant" subject as having an 80% or higher intake and is inconsistent with the efficacy reported in the results.
In the Results n, a significant decrease in mean BMI from 15.7 to 15.5 is observed (p=0.004) The authors should clarify if this reduction is interpreted as an "improvement" in body composition(potentially reducing the future risk of obesity), or if it is simply a mathematical consequence of linear height increasing at a faster rate than body weight gain during the intervention.
In the discussion the authors should discuss the specific finding that significant linear growth improvement (HAZ) was sustained only in the stunted group, and not the at-risk group, between day 90 and day 180.
The Discussion should be expanded to address the "wash-out" effect. It is not clear whether these children are expected to maintain their improved growth trajectories once the ONS is removed after 180 days.
Author Response
Please find attached.
Author Response File: Author Response.pdf
Round 2
Reviewer 1 Report
Comments and Suggestions for AuthorsWell done! The best one can do with a non-randomized study. No further objections!
Reviewer 2 Report
Comments and Suggestions for AuthorsDear authors
I appreciate your diligent efforts in addressing my feedback The revisions have significantly enhanced the clarity, depth, and overall quality of your manuscript.
