Reviewer ’s report  
 
Title: Preparing for a Clinical Trial to Test a Postpartum Weight Retention Intervention among  
Low Income Women: Feasibility of a Protocol in a Community -Based Organization  
 
Version: 1 Date: 13 Oct 2017  
 
Reviewer: Amanda R Amorim Adegboye  
 
Reviewer's report:  
 
COMMENTS:  
 
 
This is a well -written and interesting paper. Happy to see that the research team is taking the 
appropriate steps to design a community -based intervention to tackle a relevant public health 
problem (postpartum weight retention and subsequent overweight/obe sity associated with 
childbearing) and health inequality by targeting low income women. Well done!  
 
 
 
I have a number of minor comments, which I believed if addressed would enhance the quality of 
the manuscript.  
  
 
 
I am not fully convinced that this study should be considered a pilot study - I would refer as a 
feasibility trial. I am fully aware that the terms "pilot" and "feasibility" study are often used 
interchangeably in published research to indicate a study don e in anticipation of a full -scale 
clinical trial, to test out different components of the methods or to provide information that will 
help with the trial's design. However, pilot studies are often seen as miniature version of the 
main study to test whether  the components of the main study can all work together. It will 
therefore resemble the main study in many respects (design and recruitment). In this case the 
authors mentioned that this pilot is a prep work for the full -scale RCT. I assume the study will 
consist of two armed -trial with random allocation. Right? However, the design applied was a 
quasi -experimental study (pre -and post -test). My understanding is that a feasibility study is a 
piece of research done before a main study in order to answer the qu estion "Can this study be 
done?". I think that it is the case of this study. Therefore, I would replace the word trial from the 
title by feasibility.   
 
 
 
In the abstract (if space allows) it would be informative to add more details about the 
intervention (d uration) and scale of the study (N or sample size).  
 
 
Methods: Authors should provide more detailed information about the intervention activities. For 
example topics covered in the healthy eating and feeding sessions, types of exercise aid give, 
intensity o f the exercise regime prescribed, frequency and duration of each home visit (face -to-
face) contact, etc. By Knowing the intensity of the intervention the readers would feel more 
convinced about the feasibility and acceptability for the proposed interventio n. 
 
 
 
The author mentioned that focus group was performed. Were the results from the focus group 
published? If so, the authors should provide the reference. If not, more details should be given in 
the manuscript (key findings).   
 
 
 
It would be useful to defin e low income and provide details about ethnic profile.  
 
 
 
In your focus group did you find ethnic differences in terms of barriers and attitudes towards 
healthy eating and physical activity? Was the intervention design culturally tailored?  
 
 
 
If the team is pla nning to conduct a full scale RCT, willingness of participants to be randomised 
should have been included as one measure of acceptability. Was this covered in the focus group 
discussions? Did the team discuss what the population and staff considered an acc eptable 
'control' e.g. delayed intervention, no intervention?  
 
 
 
Pilot/ feasibility study can be used to inform the sample size calculation (mean and sd of primary 
outcomes). This should be mentioned as one of the aim of the present study.  
 
 
 
I appreciate that  there is little guidance in the literature re how large a pilot/ feasibility study 
should be.  Often using 10% of the sample required for a full study, may be inadequate for pilot 
studies. To the best of my knowledge feasibility trials usually included 20 -50 participants per 
arm.  Did the authors considered any rational for the sample size for this "pilot" study?  
 
 
 
Authors should include clear criteria to judge whether progression to the definitive study is 
justified. Again there are no set progression crit eria defined in the literature to use,  but they 
should aim to address whether the uncertainties that were set out to be resolved in the 
preliminary studies have been determined. In the discussion (line 203 -204) the authors 
mentioned that "the level of pen etration and attrition during the pilot was unacceptable". 
Therefore, it is important to define the threshold used to define poor recruitment rate, poor 
attrition rate, low adoption and adherence to the intervention, etc.  
 
 
 
One critical issue in all trails is recruitment/ enrollment. It seems that only 3 (out of 8) 
geographic sites contributed to recruitment. This should be considered when planning the large 
scale trial. In the discussion the authors should prove that measures are in place to guarantee 
succe ssful recruitment in a given time frame for the study.  
 
 
 
My systematic review has been updated. I suggested citing the updated version: Adegboye 
Amorim AR, Linne, Y.  
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your  comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statist ical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language i n the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing inte rests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the  future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
none 
 
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