Title: Effect of Behavior Change Communication through the Health Development Army
on Birth Weight of Newborns in Ambo District, Ethiopia: a cluster randomized controlled
community trial
Version: 2 Date: 05 Aug 2022
Reviewer's report:
Reviewer’s comments
Research title: Effect of Behavior Change Communication through the Health Development
Army on Birth Weight of Newborns in Ambo District, Ethiopia: a cluster randomized controlled
community trial
The title of the research is very good and is needed for the scientific community to know about.
The researcher's efforts to conduct this trial are greatly appreciated. In order to maximize the
benefits of the trial findings, researchers need to revise the manuscript.
General comments
1. To make the report very clear, some sections need a separate heading, especially the method
section
2. The manuscript contains redundant statements. Researchers should read and summarize
clearly
3. There is no clear flow diagram for the trial. Consort flow diagrams are highly recommended
for cluster randomized trials
4. There is a lack of clarity in some of the methodology part that needs to be improved
5. An English edition is needed for some parts of the statement
6. The second version of the manuscript should address the major comments provided below.
Abstract
Introduction: In the abstract, the researcher can describe the factors directly associated with the
diet practice and how the intervention is designed to address or reduce those factors. What factors
can behavioral change communication improve mothers' dietary practices and then improve
birth outcomes (birthweight). If the researchers could explain how the intervention mechanism
works, it would be helpful
The researcher did not consistently narrate BCC through the document. Which one is correct?
“Behavior change and communication (BCC)” or “Behavioral change communication (BCC)”;
Method: Since the research was a cluster randomized trial, the researcher would better describe
the number of clusters in the intervention and control groups included in the trial along with the
participant sample size.
Please move this statement down after the description of the tool in the abstract section of method
“The birthweight of 302 and 292 neonates in the intervention and control groups, respectively,
were measured.” This makes more sense to the reader.
A clear description of the randomization unit must be provided by the researchers. Was it a
kebele or a household? This is not clear. As I understand from the figure, randomization was
made at the individual level since pregnant mothers were randomized. Unless this is true, the
researcher needs to revise the diagrammatic figure. In a cluster randomized trial, screening of
participants should be done after randomization of clusters. Figures need to be improved in
appearance.
The researcher conducted two randomizations: one at the cluster level and one at the individual
level?
Results: I recommend using absolute risk difference and relative risk. And rather than reporting
only RR  “Pregnant women who received intervention were 61.9% less likely to have the risk low
birthweight neonates compared to pregnant women who were in the control group (ARR=0.381,
95%CI: 0.271-0.737).”
It would be better to report the absolute risk measure difference since it may not be well
understood by the readers; thus, it overestimates the intervention effect. This will reduce the
overestimation of the intervention's effect.
In addition, researchers should compare the absolute risk of low birthweight for the intervention
group and control group (0.079 minus 0.188). That gives -0.109 or -10.9%, whereas RR is
0.079/0.188=0.42 which can be adjusted to other factors
I recommend the researcher report both the relative risk and absolute risk difference when
interpreting relative risk ratios (like 61.9%).
See Consort Item 17b “For binary outcomes, presentation of both absolute and relative effect
sizes is recommended” this is not reported in the manuscript document
The researcher reported ‘by grouping pregnant women’ which is not clear for the reader
Introduction
Line number 54  ..be consistent in the use of percentage (%)
I don't see the benefit of the paragraph described from lines 74 to 77. It is up to the researcher
to decide. It would be better if the researcher described the possible interventions
According to line 78-84, the researcher noted a number of factors that could affect the low birth
weight of a baby. What factors were addressed by behavioral change communication? In order
to change behavior, what specific technique or strategy was used?
In order to demonstrate how behavioral change communication improves birth weight, the
researcher may present a diagrammatic presentation
Many public health problems, including nutrition, have been successfully addressed with
behavioral change and communication. Why does the researcher want to demonstrate the effect
of behavioral change and communication differently?
There are some statements in the introduction section that need to be summarized. There is a
lack of coherence and it seems long. It would be a good idea for the researcher to take another
look at it
Hypothesis
·       Most of the research manuscript is devoted to describing the researcher's hypothesis.
Make the hypothesis more specific, e.g. Behavior change communication through the health
development army can reduce low birthweight.
·       Were there any secondary hypotheses or research questions developed by the researchers?
Study design, study period and setting
·    There was no description of the allocation ratio in the manuscript. Consort guidelines request
this.
·       In this or the background section, the researcher should explain the rationale for cluster
randomization. Consort guidelines also recommend this
·    I would suggest the researchers clearly describe the clusters (districts or kebeles) included
in the trial in a summary way. There are some other details that can be omitted that are not
important.
Sample size determination and study population
·       It would be better to separate the section for sample size from the section for study
participants and eligibility criteria
·     How did the researchers determine the number of clusters after screening the eligible
participants? What method was used to determine the number of clusters?
·       Did the researcher have any eligibility criteria for including the cluster in the trial? Did
any clusters fail to meet the eligibility criteria?
·       Researchers calculated the sample size based on nutrition and health practices because it
gave a larger sample size, but they did not have a secondary hypothesis or outcome to test.
Recruitment, randomization and intervention allocation
·       For clarity, I suggest separating recruitment from randomization and allocation sections
·       There is a lack of clarity in this paragraph. It is necessary for the researcher to revise
·       The figure looks like two randomizations were made: at cluster level and individual. It is
recommended to adopt the consort flow diagram for cluster randomized trial
·       Did the pregnant mothers (participants) participate randomly?
Blinding
·       Health development army members and participants were blind to the hypothesis, according
to the researchers. Did the consent form not mention this?
·       The cluster randomized control trial used cluster-level allocation and concealment rather than
individual level allocation and concealment. Because of the cluster randomized trial's nature,
allocation and concealment were not done individually.
Intervention
·       The ministry of health of the government established a health development army to promote
community health.  Did the health development army not provide a health intervention to the
control group? Except for the researcher intervention, were both groups (intervention and control
groups) treated equally?
Researchers reported developing an intervention based on different guidelines, including the
WHO essential nutrition guidelines. Was it not assessed whether the messages were effective?
If the messages' content was proven to be effective, was HDA the only technique to be tested?
·       I would suggest presenting the intervention in table or figure form along with any
behavioral change techniques applied, such as theoretical education, demonstration, along with
each intervention content. Additionally, I suggest that the researchers include a table showing
any supportive intervention like a poster. It cannot be clear unless the intervention provides this
information
·       The researchers need to improve this section. Some of the statements were repeated. This
section needs summarization
·       The researcher conducted 6 sessions of BBC for pregnant mother before 16 weeks of
gestation for 12 weeks. How the researchers justify the 6 sessions of BCC can reduce the low
birthweight
·       Did the researcher use any behavioral theory or model when developing and/or implementing
BCC? What is the reason if not? To demonstrate the conceptual relationship between factors,
outcomes, and interventions in BCC interventions, theory or models are highly recommended.
·       Researchers may use two headings; intervention and implementation, to clearly describe
the interventions and implementations. It is possible for researchers to read the consortium
guidelines about what can be included in the intervention and implementation sections.
·       The 6 sessions assigned to the intervention group were successfully implemented in
all clusters? Did all participants complete all six sessions in the intervention group? What
mechanisms did the researchers use to monitor this?
A clear distinction between the intervention and control groups along with a description of what
intervention group participants received and what control group participants received makes
sense to the reader. In addition to the intervention, the researchers can describe how the two
groups are comparable
Intervention group-
e.g. Pregnant mothers in the intervention group cluster were received BCC intervention using
HAD for ……period in addition to (some routine standard
Control group:
Data collection
·       Can you tell me where the outcome data was collected and how it was collected? In a
health facility? Hospital? How?
·       A summary of the questionnaire's information is needed by the researcher along with their
reference
Outcome
In the trial, the researcher needs to define the primary and secondary outcomes as well as how
and when they were measured. Neither the protocol of the supplementary document nor the
researcher's study showed the measured variables at different timelines (baseline and endline).
Data analysis
·       Was there a sensitivity analysis conducted by the researcher? Did the trial analysis follow
the protocol or was it based on intent to analyze? What was the method of application?
·       Did the low birthweight proportions apply to clusters or to individuals? What was the
justification for the researchers?
·       “The effect of intervention was measured at endpoint of follow up.”  The outcome
measurement and timeline need to be showed other section
·       “Although the authors sought to apply a two-level intercept only multilevel binary logistic
regression analysis, the likelihood ratio test performed to compare multilevel model analysis to
ordinary binary logistic regression shows that the two models are similar (X2 (df=1) = 0.63, p-
value= 0.215).” This statement is not clear
·       There is no intra-cluster analysis report included in the table. The consort guidelines
recommend this. The guidelines should be referred to.
·       The effort made in the cluster's similarities before randomization is also important in
controlling confounding factors. How did all clusters compare when it came to confounding
variables?
Result
·       Socio-demographic characteristics of pregnant women who enrolled are not reported by the
researchers. It is important to describe each stage of the flow diagram. It is necessary to know
the full baseline characteristics of the enrolled participant. The researcher should also upload
the sociodemographic characteristics excluded participants from analysis
·       What statistical test did the researcher use for table 2? This statistical test was not included
in the analysis
·       In addition to the primary and secondary hypothesis, the researcher did not describe the
primary and secondary outcomes. As a result, the reader will not be able to understand the result
·       In the trial manuscript, the researcher reports "Factors associated with birthweight among
newborns delivered in Ambo district.". Can you explain why this was included in the trial report?
Discussion
·       Researchers discussed the birthweight of newborns as a discussion point. The hypothesis
of the researcher is to reduce the low birthweight. Therefore, it should be consistent
·       The same comment as above regarding the primary and secondary outcome
What was the cause of the birth weight difference? the development health army? The behavioral
change and communication? or other elements of behavioral change and communication that
are embedded in the intervention. This is to be explained in the manuscript, but the researcher
should make strong recommendations about any new different strategy used in the behavioral
change technique that brings the change.
Ethical
Is the setting difference enough reason to do the RCT that has already been proven in
Bangladesh? In this study, how did the researchers use a different technique to justify that?