Title: The impact of a lifestyle promotion program on anthropometric and clinical
manifestations in adolescents with polycystic ovarian syndrome: a randomized controlled trial
Running title: Lifestyle promotion program in adolescents with polycystic ovarian syndrome
Version: 1 Date: 24 Jan 2024
Reviewer's report:
Dear authors,
I would like to congratulate you on the important study. It is always important that this topic is
investigated, and the sooner it is addressed, the better, as they actually pointed out. However,
there are numerous adjustments to be made, which is why at this time it is not possible to be
accepted. Below I made some notes and provocations that I made with the aim of improving
it for a future submission.
Abstract
1) At the beginning of the summary it is important to also mention the clinicians, as they did
not only analyze the anthropometrics
2) I suggest using versus (when comparing data in results).
3) Mention what made up the lifestyle promotion program.
4) Please reformulate the conclusion. She was confused by information that perhaps was not
part of the conclusion.
Introduction
- Review some points in the introduction, especially the objective. Did the lifestyle promotion
program actually aim to observe the manifestation of polycystic ovary syndrome after its
implementation? For me it was very broad and it would be more coherent to mention, as in other
parts of the text, body composition and clinical aspects. In short, the manifestation of PCOS is
broad, with several aspects that were not observed in this study.
- Furthermore, the objectives presented at the end of the introduction, such as the one that
mentions the comparison of obese women, I missed in the summary, as well as the insertion of
the conclusion of this aspect that they aimed to evaluate.
- It is important to update references/citations, especially those that mention physical exercises,
given that there are already much more recent publications on the subject.
- Because the study was randomized, why were the groups unbalanced even before the
exclusions? For example, 35 girls in the PCOS intervention group and only 29 without
intervention?
Methodology/Results
- What are professional exercises? Would it be a physical training program?
- Insert the citation/bibliographic reference of the diagnosis from the American Society of
Reproductive Medicine
- It is necessary to mention all equipment, brands/models/country of development and techniques
for each measurement, including each biochemical measurement.
- Has it been reported on how measurements will be taken of patients without oligomenorrhea
and those with oligomenorrhea?
- Regarding sampling, the calculation carried out indicated 56 SOP and 56 without SOP. What
is the requirement to include more people in the exams since a smaller number was needed? If
considered a possible loss of 20% as justified, wouldn't a higher N be necessary?
- Do you have baseline data for all hormones and measurements that are used for inclusion
and exclusion criteria? They are necessary, such as testosterone. They need to be presented
as a baseline characterization of the sample. It is necessary to compare them and if there are
differences, make an adjustment statistic, as starting from different base values, they can produce
different effects.
- In statistics, it is necessary to evaluate the normality of the data and only then decide by t-test
vs mann Whitney analysis. Review the statistics.
- Because they are classes (that's what I understood when reading the methodology in the
published article) and there is no detailed description of how it was done, which makes it
impossible for this study to be reproducible, due to the specificity that the researcher may have
involved in them. Therefore, it would be important to provide more clarity on these methods so
that they could be reproduced.
- How were the students monitored in relation to what type of exercise to practice (example:
strength, aerobic?), intensity, duration, frequency? Location where the activities were carried
out (open, closed environments?) Was there any standard? Was there a nutritionist on the team
who provided nutritional guidance? What were the guidelines? Were the teenagers accompanied
at each physical training session? How were the training pillars guaranteed for them? What
protocol is used?
- Question: The study objectives mention the issue of comparing obesity. I didn't see anything
about it in the methods. It was made?
- Two questionnaires were mentioned to measure the level of physical activity, however, I was
unable to view the results of both, before and after (6 and 12 months). It is important to present
and compare them, so that it is possible to check how much the volume of exercises increased
in each group, after classes. I have not seen critical analyzes of the characteristics of the groups
at different times.
- Regarding the characterization of their weight, is there data? It is important to present and
perform statistical adjustments if any of the groups have different baseline anthropometric data.
It is clear that the closer you get to a leaner state, the more difficult it is to lose measurements
and weight. The same can occur when reaching very high levels where physiological and
biochemical problems could make it difficult.
- It is important to highlight the main differences between your study and the study: ‘’ 35.
Abd Elmenim SO, Emam AJIJ. Effect of lifestyle changes on symptoms of polycystic ovarian
syndrome in obese girls. Journal of nursing and health science. 2016;5(3):1-10.’’, so that it is
actually possible to give greater exclusivity/importance to what they studied.
Discussion
- Check the objectives in the introduction. They must meet the beginning of the discussion.
- In the results, in relation to ‘’hyperandrogenic signs’’, only menstrual regularity was
cited as statistically significant. In this part, it is therefore important to mention instead of
‘’hyperandrogenic signs’’ that menstrual regularity has increased (also using just the term
‘’changes’’ does not indicate whether it has changed for the worse (minor) or better (major).
- It is important to review the term ‘’physical activity’’ in the text. The correct term for a
physical training program is ‘’physical exercise’’. This is programmed, has regularity/frequency,
intensity and duration, and can be measured and reproduced. Physical activity alone can be a
simple act of taking a shower, washing dishes, etc.
- Based on the previously proposed adjustments, especially in the methodology/results, the
discussion would need to be revised based on what was found/information to be included.