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: 27 Sep 2017  
 
Reviewer: Christine Olson  
 
Reviewer's report:  
 
Revi ew of MSS#BMWH -D-17-00289R1, Preparing for a Clinical Trial to Test a Postpartum 
Weight Retention Intervention among Low Income Women:  Piloting a Protocol in a 
Community -Based Organization  
 
 
The objective of this study is "to pilot a PPWR (postpartum weigh t retention) intervention in 
partnership with a community -based organization (CBO) serving low -income families with 
social support."  Postpartum weight retention is an important public and women's health issue 
and the authors are using an appropriate appro ach to addressing it.  The overall issues with the 
study and the paper are a very rudimentary conceptual model of the targets for intervention, the 
intervention components, and how they relate to the primary outcome and secondary outcomes, 
an initially sma ll sample size with high levels of loss to follow -up, potentially inappropriate 
statistical analyses, and a general lack of detail on potentially important findings and what they 
mean for the design of the clinical trial.  
 
 
 
Additional Comments to Authors:  
 
1) Abstract, Lines 33 - 35 - I think what you want to say here is something more like, "Other 
secondary outcomes were the change in psychosocial and clinical measures from baseline 
to one year following delivery."  The baseline measure is not an outcome.  
 
 
2) Lines 59 -62 - Given the now fairly large number of intervention and observational 
studies that have been carried out on the topic of postpartum weight retention including 
some with low income audiences and with non -white samples, it is appropriate to cite  
reviews and meta -analyses here.  But the authors need to be sure to cite the most recent 
and comprehensive reviews.  In that regard, the Amorim et al. Cochrane Review was 
updated in 2013.  It is Issue 7, Art. No. CD005627.  In addition, since the authors claim is 
that none of the previous intervention studies look place in a community -based setting (a 
statement about which I am skeptical), they need to cite specific references to support this 
claim.   
 
 
3) Line 70 - Cite a reference for the Theory of Planned  Behavior.  I say that because this 
theory evolved from the Theory of Reasoned Action (that includes the constructs the 
authors mention in the paper), but adds two constructs:  perceived behavioral control and 
perceived power, according to Mark Edberg in t he "Essentials of Health Behavior," 2007.  
 
 
4) Lines71 -78 - A reference is not included for the study that describes the 4 intervention 
components.  Please include.  Reference 12 that is used earlier in the paper describes the 
development of the measures fo r some of the psychosocial constructs and their 
relationship to gestational weight gain.  
 
 
5) Lines 80 -81 - I think it would be clearer to say that you are studying 5 of the 8 
conceptually distinct outcomes that Parker et al. include in their model.  Those y ou are 
not studying are appropriateness, fidelity and implementation cost.  Why did you not 
choose to include these?  
 
 
6) Lines 85 -86 - The conceptual model in Figure 1 is very rudimentary and lacks important 
details such as the specific behavior changes tha t are the target of intervention.  Also do 
the authors think that any of the secondary outcomes are on the pathway to achieving the 
primary outcome?  If so, this should be shown on the model.  I'd think that breastfeeding 
and diet composition would be.  Th e model would be more useful, if it specified which 
intervention components were aimed at which theoretical constructs and which 
behaviors.  
 
 
7) Line 109 - The "one of 3 initial classes" is confusing.  It sounds like there were 3 
different classes and women  only had to attend one.  But now that I have read the whole 
paper, I think that what you mean is that an initial class was offered at each of the 3 sites 
from which study participants were ultimately recruited.  Whatever the case, this needs to 
be clearer . 
 
 
8) Lines 142 -143 - How do you know if the scripts were followed?  Do you have any 
measures of fidelity, an implementation outcome specified by Parker et al.?  
 
 
9) Data analysis section, Lines 152 -156 - In your data analysis you are comparing "those 
who be gan the pilot and those retained in follow -up one year later," according to the 
manuscript.  Those retained are a subset of those who began, so the two samples are not 
independent.  The manuscript does not indicate that paired t -tests were used, which I 
believe would be the appropriate t -test.  However, the other issue is that the total n is then 
9 which is a small number for statistical analyses.  A statistical consultant should give an 
opinion on these issues.  
 
10) Results section - Given the small and cha nging sample sizes, rather than just giving 
percentages, I strongly suggest giving both the numerator and the denominator for each 
percentage in the Results section.  For examples in line 160 - ". . . with 30% (5/17) by six 
weeks, 35% (6/17) at 6 months, a nd 47% (8/17) attrition at one year."  
 
 
11) Line 182 - Foundation does not need to be capitalized here.  
 
 
12) Line 194 -195 -The problem with saying that the proportion of women with depression 
did not change over time is that the sample size changed quite a bi t across time.  So I 
guess that depression was not related to staying in the study.  
 
 
13) Lines 216 -218 - In my view, the authors are describing an important decision that they 
made on the basis of this study, at this point in the manuscript.  But the statem ent is very 
confusing.  It sounds like you made the initial class longer.  Be clearer in stating the 
decision made and give more detail on how many more classes and/or home visits we 
added, if that is what the investigators did.  
 
 
14) References - I am not s ure whether the authors are following the journal's style for 
references or not.  But I am pretty sure that page numbers need to be included in each 
reference and in reference 12, no page numbers were included.  They are 332 -343. 
 
 
15) Figure 1 - This figure  is so rudimentary that it is not worth including as it is.  If it can be 
expanded with more detail as described above, then it could be included.  
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your  comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Unable to assess  
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 recommend additional statistical review  
 
Quality of written English  
Please indicate the quality of language i n the manuscript:  
 
Needs some language corrections before being publish ed 
 
 
 
 
Declaration of competing interests  
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