Behavioral Change Communication Intervention in Menstrual Disorder Management Among Female University Students in Bangladesh
Phase: NA
Conditions: Dysmenorrhea, Premenstrual Syndrome-PMS, Menstrual Irregularity
Sponsor: Shahjalal University of Science and Technology

1 
 
 
Combined Document: Study Protocol, Statistical Analysis 
Plan (SAP), and Informed Consent Form (ICF) 
 
 
Official Title of the study: Behavioral change communication 
intervention in menstrual disorder management among female 
university students in Bangladesh 
 
 
 
Professor Dr. GM Rabiul Islam 
Principal investigator of the study  
Shahjalal University of Science and Technology (SUST), Sylhet, Bangladesh 
 
Document date: 26 May 2025 
Approved by the SUST Research Ethics Board (Ref: AST/002/258) 
 

2 
 
 
Study Protocol 
Brief summery  
Menstrual health is a neglected area of women’s health research, especially in low- and middle-
income countries, despite the high prevalence and impact of menstrual disorders on daily life. 
These issues are particularly common among young women in academic settings, yet few 
interventions address them holistically. In Bangladesh, female university students frequently 
experience dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI), 
conditions often worsened by modifiable lifestyle factors such as poor diet, physical inactivity, 
and food cravings. This study assessed the effectiveness of Behavior Change Communication 
(BCC) intervention promoting non-pharmacological strategies to improve menstrual health among 
female university students. 
A quasi-experimental design included 498 participants (249 per group), aged 19–25, from three 
public universities. The intervention group received three interactive BCC sessions on menstrual 
disorders, diet, and physical activity (including yoga) between May and June 2023, followed by 
bi-monthly visits for six months. Post-intervention data were collected from February to March 
2024. Outcomes (dysmenorrhea, PMS, MI) were measured using validated tools. Propensity score 
matching (1:1 nearest-neighbor, caliper = 0.01) yielded 98 matched participants per group. 
Covariates included physical activity, body mass index (BMI), dietary diversity, food cravings, 
breakfast skipping, sleep, bedtime, caffeine intake, and socio-demographic factors. Data were 
collected via validated Bengali questionnaires. Analyses included descriptive statistics, chi-square 
and t-tests, logistic regression, and sensitivity analyses. Ethical approval was granted by the 
Shahjalal University Ethics Board.  

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Detailed description of the study  
Menstrual health is a significantly under-researched aspect of women’s health, particularly among 
adolescents and young adults in low- and middle-income countries(1), even though menstrual 
disorders affect up to 75% of them and often interfere with daily functioning and overall well-
being. (2). In Bangladesh, female university students frequently experience menstrual disorders 
such as dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI). These 
conditions are often aggravated by modifiable lifestyle factors including poor dietary intake, 
physical inactivity and food cravings for high fat and sweet food (3).  
This study evaluated the effectiveness of a structured behavior change communication (BCC) 
intervention designed to improve menstrual health among female university students in 
Bangladesh. The intervention focused on three key menstrual health outcomes: dysmenorrhea, 
PMS, and MI. It promote a sustainable, non-pharmacological approach to managing common 
menstrual disorders through behavior and lifestyle changes including improved physical activity 
and dietary diversity.  
The study employed a quasi-experimental design involved two groups: an intervention group that 
received BCC module and a control group that did not. Participants were female undergraduate 
students aged 19 to 25 years, residing in dormitories at three public universities in Bangladesh i.e. 
Patuakhali Science and Technology University (PSTU), Barishal University (BU), and Khulna 
University (KU). Ethical approval was obtained from the Shahjalal University of Science and 
Technology Research Ethics Board (Ref. No. AST/002/258), and all participants provided written 
informed consent. The BCC intervention comprised three interactive educational sessions 

4 
 
 
delivered between May 20 and June 30, 2023, by trained female facilitators. The first session 
addressed menstrual disorders and associated risk factors, the second focused on healthy dietary 
practices, and the third emphasized physical activity (including yoga) and other relevant lifestyle 
modifications. To reinforce the content, follow-up visits were conducted every two months over a 
six-month period. Post-intervention data collection was carried out between February and March 
2024. 
A total of 498 participants (249 in each group) were initially enrolled, based on power calculations 
designed to detect a 30% reduction in the prevalence of menstrual disorders, with 80% statistical 
power and 95% confidence level. After exclusions for missing data and loss to follow-up, 234 
intervention and 238 control participants were included in the analysis of dysmenorrhea; and 228 
participants per group were retained for PMS and MI outcomes. To reduce selection bias and 
ensure covariate balance, 1:1 nearest-neighbor propensity score matching (PSM) was applied 
using a logistic regression model with a caliper of 0.01 and no replacement. The final matched 
sample included 196 participants (98 per group) for each outcome. 
Among all the primary outcomes, dysmenorrhea was assessed using the Andersch and Milsom (4) 
four-point scale and dichotomized as no pain (Grade 0) vs. any pain (Grades 1 – 3). PMS was 
evaluated by the premenstrual symptoms screening tool (PSST) and recoded into a binary variable: 
No/Mild PMS (code = 0) and Moderate to Severe PMS or premenstrual dysphoric disorder 
(PMDD) (code = 1) (5). Additionally, Menstrual irregularity was determined based on self-
reported cycle length and coded as irregular (1) if <21 or >35 days, and not irregular (0) if within 
the 21–35 day range (6).  

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The treatment variable was exposure to the BCC intervention (yes/no). The covariates included 
physical activity, obesity, dietary habits, lifestyle factors, and socio-demographic characteristics. 
Physical activity was classified according to WHO guidelines (7) as: (i) sedentary: light-intensity 
activities; (ii) active: moderate-intensity activities for 150–300 minutes per week; and (iii) athlete: 
vigorous-intensity activities for 75–150 minutes per week. Obesity was assessed using body mass 
index (BMI, kg/m²) and categorized according to WHO Asian-specific cut-offs (8): (i) 
underweight (<18.5), (ii) normal weight (18.5–22.9), (iii) overweight (23.0–27.5), and (iv) obese 
(>27.5). Dietary information was collected using a five-day 24-hour recall method, and dietary 
diversity score (DDS) was calculated following FAO guidelines (9) . Lifestyle-related covariates 
included food cravings for high-fat or sweet foods (10), skipping breakfast, sleep duration, bedtime 
and caffeine intake (11). Socio-demographic variables included family history of menstrual 
disorders, age at menarche, marital status, and participants’ residence as well as parental 
educational and occupational status.  
Data were collected through interviewer-administered, culturally adapted, and validated Bengali- 
questionnaires. Descriptive statistics summarized baseline characteristics. Group differences were 
tested using chi-square and t-tests. Propensity scores were estimated using logistic regression, and 
covariate balance post-matching was evaluated using standardized mean differences (SMD 
<10%). Intervention effects were analyzed using conditional logistic regression on the matched 
sample, and logistic regression (bivariate/multivariate) on the unmatched sample. Sensitivity 
analyses included covariate balance diagnostics, estimation of average treatment effects 
(ATE/ATT), and Bayesian logistic regression with log Bayes factor. 

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This study complies with U.S. regulatory requirements for clinical trial registration and reporting 
under 42 CFR Part 11. The responsible party confirms that all submitted information is complete 
and accurate, and that the study protocol, statistical analysis plan (SAP), and informed consent 
form (ICF) reflect the approved trial objectives and design.     
Participant flow 
Recruitment details 
Female students were recruited from three public universities in Bangladesh: Patuakhali Science 
and Technology University (PSTU), Barisal University (BU), and Khulna University (KU) for a 
BCC module on menstrual health from May 20 to June 30, 2023. Recruitment occurred via campus 
outreach and voluntary registration. University-approved session dates were held in campus 
venues. Follow-up occurred from July 15, 2023, to January 15, 2024. A post-intervention 
assessment was conducted from February to March 2024 through comparing the intervention 
group to the control group. 
Pre-assignment details 
Initially 498 participants (249/group) were recruited. Seven intervention participants were 
excluded before assignment for missing sessions/protocol violation, leaving 242. At six-month 
follow-up, 480 participants (239 intervention, 241 control) completed assessments as because 3 
intervention and 8 control participants were excluded due to missed follow-up or withdrawal. After 
data checks, 8 were excluded for invalid dysmenorrhea data, leaving 234 intervention and 238 
control (total 472 participants) for that outcome. For PMS and MI, 24 more were excluded (10 

7 
 
 
intervention and 14 control group), yielding 456 participants (228 per group). Propensity score 
matching (PSM) identified 196 matched participants (98 per group) for each of outcomes. 
Group information 
Two groups were assigned: an intervention group receiving the BCC module on menstrual health, 
and a control group with no intervention. Participants were female university students from PSTU, 
BU, and KU, Bangladesh, with group assignment based on attending at the BCC sessions. 
Group title 
1. Intervention Group 
2. Control Group 
Group description 
The Intervention group comprised female university students from PSTU, BU, and KU who 
participated in a structured BCC module designed to enhance awareness and promote effective 
management of menstrual disorders through lifestyle and behavioral modifications. The module 
consisted of three interactive sessions that included educational presentations, yoga 
demonstrations, informational pamphlet distribution, quiz competitions, and small gift incentives 
to boost engagement. Sessions were facilitated by trained female educators under the guidance of 
a public health expert and a gynecologist. Participants were selected through voluntary registration 
and received follow-up support at every two months to reinforce behavioral changes, address 
challenges, and ensure continued adherence to healthy practices. 

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The Control group consisted of female students from the same universities who were not exposed 
to the BCC intervention. They were selected using student dormitory records and matched to the 
intervention group through propensity score matching to ensure comparability. As they did not 
receive any form of menstrual health education or BCC intervention, this group served as the 
baseline comparator for evaluating the effectiveness of the BCC module on menstrual health 
outcomes.     
Period(s) 
This study was organized into three distinct periods to reflect the logical progression of the 
intervention and its evaluation: (1) implementation of the intervention, (2) follow-up phase to 
monitor and support behavior change, and (3) post-intervention evaluation to assess outcomes. 
Each period captured critical milestones and participant flow to assess the feasibility, adherence, 
and effectiveness of the intervention.  
 
Period 1: Implementation of the intervention 
The first period of the study involved the implementation of a structured BCC intervention among 
female university students to enhance awareness and promote effective management of menstrual 
disorders. Three structured sessions were conducted covering menstrual disorders, dietary 
behaviors, and physical activity. Two trained female educators facilitated these sessions. The 
details of participation status of this period is presented in Table 1.  
 
 
 

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Table 1. Summary of participation status and key milestones in intervention implementation 
Participation 
status 
Data 
 (number of 
participants) 
Comments 
Milestone title 
Milestone 
data 
(number of 
participants) 
Started 
249 
(Intervention Group) 
 
249 
(Control group) 
Intervention: participants 
who registered after informed 
consent and attended the first 
session of BCC module  
 
Control: Participant from the 
same universities were 
selected and listed after 
providing consent for the 
assessment study.  
Intervention: 
first session 
attendance 
 
Control: Not 
exposed to the 
BCC 
intervention 
249 
(Intervention 
Group) 
 
249 
(Control 
group) 
Completed 
242 
(Intervention Group) 
Participants who attended all 
three intervention sessions. 
Completed all 
sessions  
242 
Not completed 
7 
(Intervention Group) 
Participants dropped out 
before completing the 2nd 
and/or 3rd session. 
Protocol 
violation 
7 
 
Period 2: Follow-up phase  
This was a six-month post-intervention follow-up period, during which participants in the 
intervention group received periodic support visits to reinforce behavioral changes and sustain the 
practices introduced during the BCC sessions (Table 2).  
Table 2. Overview of participation status and milestone achievements in follow-up phase 
Participation 
status   
Data 
 (number of 
participants) 
Comments 
Milestone title 
Milestone 
data 
(number of 
participants) 
Started 
242 
(Intervention Group) 
Participants who completed 
all the sessions of the 
intervention and entered 
follow-up phase. 
Follow-up 
initiated and 
available at 
first follow-up 
visit  
242 

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Completed 
239 
(Intervention Group) 
Participants available at 6-
month follow-up assessment. 
Follow-up 
completed 
239 
Not completed 
3 
(Intervention Group) 
Participants lost to follow-up 
during the periodic 
monitoring visits conducted 
every two months.  
Lost to follow-
up 
3 
 
Period 3: Post-intervention evaluation  
This period represents the final stage of the study to assess the effectiveness of the BCC module 
on key menstrual health outcomes through a quasi-experimental design using matched control and 
intervention participants (1:1 PSM) (Table 3, Table 4A and 4B). Outcome assessments were done 
for dysmenorrhea, PMS and MI.  
 
Table 3. Participant flow and milestone completion in post-intervention outcome evaluation before 
matching  
Participation 
status   
Outcomes 
Data 
 (number of 
participants) 
Comments 
Milestone 
title 
Milestone 
data 
(number of 
participants) 
Started 
Dysmenorrhea, 
PMS and MI 
239 (Intervention), 
241 (Control) 
Participants agreed to 
join and assessed for 
final evaluation of 
outcomes  
Assessment 
initiated 
480 
Completed 
 
Dysmenorrhea 
234 (Intervention), 
238 (Control) 
Participants included 
after cleaning for 
dysmenorrhea 
outcomes. 
Valid 
responses  
472 
PMS and MI 
228 (Intervention), 
228 (Control) 
Final sample 
included participants 
with valid PMS and 
IMC outcome data 
Appropriate 
responses  
456 
Not completed  
Dysmenorrhea 
8 (5 intervention 
and 3 control) 
Omitted from the 
final dataset due to 
Incomplete 
response  
8 

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data quality issues, 
including missing or 
invalid responses 
PMS and MI 
24 (11 intervention 
and 13 control) 
Removed from 
analysis because of 
incomplete or 
inaccurate data.  
Invalid 
response/ 
missed data 
24 
 
 
Table 4A. Participation flow of matched sample for post-intervention dysmenorrhea analysis 
Participation 
status   
Groups 
Data 
 (number of 
participants) 
Comments 
Milestone 
title 
Milestone 
data 
(number of 
participants) 
Started 
 
 
Intervention 
234 
Out of 234 eligible 
participants, 98 were selected 
using PSM and individually 
matched in a 1:1 ratio with 
control participants within the 
common support region.  
Enrollment  
 
472 
Control 
238 
All participants initially 
eligible; matched pool was 
drawn from this group 
Completed 
Intervention 
98 
All 98 matched completed the 
post-intervention evaluation 
Matching 
completion 
and final 
outcome 
analysis  
196 
Control 
98 
98 matched controls completed 
the evaluation and the 
remaining controls not 
matched due to 1:1, no-
replacement rule 
Not completed 
Intervention 
136 
The participants were excluded 
from the analysis because they 
could not be matched with any 
control participants within the 
specified caliper of 0.01  
Excluded 
due to fall   
outside the 
region of 
common 
support 
276 
 
Control 
140 
Even though these participants 
fell within the common 
support region, they were 
excluded because of the 1:1 
matching requirement and the 
no-replacement rule.  
Not selected 
due to 1:1 
matching 
without 
replacement 

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Table 4B. Matched sample of participants for post-intervention assessment of PMS and MI outcomes 
Participation 
status   
Groups 
Data 
 (number of 
participants) 
Comments 
Milestone 
title 
Milestone 
data 
(number of 
participants) 
Started 
 
 
Intervention 
228 
From the pool of 228 eligible 
participants, 98 were chosen 
using PSM and matched one-
to-one with control 
participants within the 
common support region. 
Enrollment  
 
 
 
 
 
 
 
456 
Control 
228 
A subset of matched 
participants was selected from 
all 228 initially eligible control 
individuals 
Completed 
Intervention 
98 
All 98 participants in the 
matched group successfully 
completed the post-
intervention assessment.  
Matching 
completion 
and final 
outcome 
analysis  
196 
Control 
98 
The evaluation was completed 
by 98 matched control 
participants while the rest were 
excluded in accordance with 
the 1:1 matching and no-
replacement criteria.  
Not completed 
Intervention 
130 
As no matches within the 
caliper of 0.01 could be 
identified, the participants 
were excluded from the 
analysis 
Participants 
were 
excluded as 
they did not 
fall within 
the region of 
common 
support. 
260 
Control 
130 
Despite being within the 
common support region, these 
participants were excluded to 
maintain the 1:1 matching 
ratio and adhere to the no-
replacement rule.  
Excluded 
because of 
1:1 
matching 
without 
replacement. 
 
 

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Baseline characteristics 
Group information  
Group title 
1. Intervention Group 
2. Control Group 
Group description 
The intervention group included participants who attended all three sessions of the BCC module 
on menstrual health management. Initially, 249 participants were recruited, and 242 completed all 
sessions. At the six-month follow-up, 239 participants completed the outcome assessment. After 
data cleaning, 234 participants were eligible for the final analysis of the dysmenorrhea outcome, 
while 228 participants had valid data and were included in the analyses of PMS and MI.  
Participants in the control group did not receive the BCC intervention but were matched in number 
and characteristics to the intervention group. Initially, 249 participants were listed for the control 
arm, and 241 completed the outcome assessment interview. Following data quality verification, 
238 participants were included in the final analysis for the dysmenorrhea outcome. For the PMS 
and MI outcomes, 228 participants had valid and complete data and were included in the respective 
analyses. 
After propensity score matching, 98 matched participants from each group (n=196) were used for 
the final analysis of each outcome variable, ensuring balance between the groups on key covariates. 
 
 

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Baseline analysis population information 
 The baseline analysis populations differ slightly from the initial recruitment numbers due to participant 
withdrawal, non-response, absence during sessions or protocol violation, and exclusion based on data 
quality checks for outcome variables (Table 5).  
Table 5. Baseline Profile of Participants by Study Group: Intervention vs. Control 
 
Baseline Measure Information  
The baseline characteristics of study participants were assessed using a combination of study-
specific and standard measures to comprehensively capture their lifestyle, nutritional, 
reproductive, and socio-demographic profiles (Table 6). Study-specific measures included 
Outcome 
Group 
Overall number 
of baseline 
participants 
Baseline analysis population 
description 
Dysmenorrhea 
Intervention 
234 
After recruitment and data quality checks, 
234 participants were included in the initial 
analysis. After propensity score matching, 98 
were retained.  
Control 
238 
From 238 eligible controls, 98 matched 
participants were used in the final matched 
analysis.  
Total 
472 
The final matched sample included 196 
participants (98 per group), selected through 
1:1 propensity score matching without 
replacement using a caliper of 0.01.  
PMS and MI  
Intervention 
228 
228 participants provided valid and complete 
responses and were included in the baseline 
analysis. After matching, 98 were included in 
the final matched analysis.  
Control 
228 
228 participants were eligible for baseline 
analysis. After matching, 98 were used for 
final analysis.  
Total 
456 
A total of 196 participants (98 in each group) 
were retained after 1:1 matching with a 0.01 
caliper and no replacement.  

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physical activity level (categorized according to WHO guidelines), body mass index (BMI) using 
Asian-specific cut-offs, and minimum dietary diversity (MDD) based on a 5-day food diary 
aligned with FAO recommendations. Additional lifestyle factors assessed included food cravings, 
skipping breakfast, sleep duration, caffeine intake frequency, and bedtime. Reproductive health 
and demographic factors such as age, age at menarche, marital status, and participant’s residence, 
family history of menstrual disorders, as well as parental education and occupation were also 
recorded. These baseline measures were used to describe the participant population and to adjust 
for potential confounding in subsequent analyses.  
To evaluate the impact of the BCC intervention on reducing dysmenorrhea, key covariates were 
balanced between groups using propensity score matching. These included physical activity level, 
BMI, minimum dietary diversity (MDD score ≥ 5), food cravings for high-fat and sweet foods, 
breakfast skipping, sleep duration, caffeine intake frequency, family history of menstrual 
disorders, age at menarche, marital status, father’s and mother’s educational status, and mother’s 
occupation. These balanced covariates (13 covariates) were included in the regression models and 
in the estimation of both the average treatment effect (ATE) and the average treatment effect on 
the treated (ATT). 
Additionally, to assess the effectiveness of the intervention on PMS and MI outcomes, propensity 
score matching was used to achieve balance in key baseline covariates between the intervention 
and control groups. The matched covariates included physical activity level, BMI (kg/m²), 
minimum dietary diversity (MDD score ≥ 5), food cravings for high-fat and sweet foods, breakfast 
skipping, sleep duration, age at menarche, and participants’ residence. These variables (8 
covariates) were subsequently adjusted for in the estimation of treatment effects.        

16 
 
 
Table 6. Baseline characteristics of participants by defined study measures 
Baseline 
measure title 
 
(Study-specific 
measure) 
Study-specific 
baseline measure 
title(s) 
Baseline measure description 
Measure 
type 
Measure 
of 
dispersion 
Category 
title 
Unit of 
measure 
Physical activity 
Physical activity level  
Categorized per WHO recommendations 
based on weekly activity intensity: sedentary 
(with little or no activity), active 
(moderate, 150–300 min/week) and athlete 
(vigorous, 75–150 min/week). Active and 
athlete were merged during analysis  
Count of 
participants 
Not 
applicable 
Sedentary/ 
Active and 
athlete 
Participants 
Body mass index 
(BMI) 
BMI (Kg/m2) 
Classified using WHO cut-offs for Asian 
populations, such as underweight (<18.5), 
normal (18.5–22.9) and overweight/obese 
(≥23.0). Overweight and obese categories 
were merged. 
Count of 
Participants 
Not 
applicable 
Underweight / 
Normal / 
Overweight 
and obese 
Participants 
Dietary diversity 
Score (DDS) 
MDD (scoring ≥ 5)    
Dietary diversity was assessed using a 5-day 
food diary based on the 24-hour recall 
method, following FAO guidelines. Food 
items were classified into 10 predefined 
groups, and scores ranged from 0 to 10. 
Minimum dietary diversity (MDD) was 
defined as achieving a score of 5 or more.  
Count of 
participants 
Not 
applicable 
Yes / No 
Participants 
Food Craving 
Food craving for 
high-fat and sweet 
food  
Self-reported craving for high-fat and sweet 
food.  
Count of 
participants 
Not 
applicable 
Yes / No 
Participants 
Skipping 
breakfast 
Skipping breakfast  
Reported skipping breakfast one or more 
times during the last week. 
Count of 
participants 
Not 
applicable 
Yes / No 
Participants 
Sleep duration 
Sleep hours per night  Based on self-reported average nightly sleep 
duration 
Count of 
participants 
Not 
applicable 
<7 hrs / ≥7 hrs 
Participants 
 
 
Caffeine 
consumption 
 
 
Frequency of caffeine 
Intake  
Based on frequency of caffeine intake per 
week; categorized as infrequent (<3 
times/week) or frequent (≥3 times/week) 
Count of 
participants 
Not 
applicable 
Infrequent / 
Frequent 
Participants 

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Bedtime  
Bedtime (hours) 
Bedtime was classified into two groups: 
≤23:00 hours and >23:00 hours, based on a 
24-hour clock format 
Count of 
participants 
Not 
applicable 
Before or at 
23:00 / After 
23:00 
Participants 
Family history of 
menstrual 
disorders 
Family history of 
menstrual disorders 
Participants reported whether they had 
family history of any kind of menstrual 
disorders viz. dysmenorrhea, PMS, or IMC.  
Count of 
participants 
Not 
applicable 
Yes / No 
Participants 
Age  
(Not study-
specific measure) 
Age  
Treated as continuous variable   
Mean 
Standard 
deviation 
Not applicable  
Participants 
Menarche age 
Age at menarche  
Reported age at first menstruation in years 
and treated as continuous variable. 
Mean 
Standard 
deviation 
Not applicable  
Participants 
Marital status 
Marital status 
Marital status was self-reported. Participants 
categorized as divorced, separated, or 
recently married were grouped under ever 
married. All others were classified as never 
married. 
Count of 
participants 
Not 
applicable 
Never married 
/ Ever married 
Years 
Residence 
Participant’s 
residence 
Living arrangement of the participants during 
the study time. 
Count of 
participants 
Not 
applicable 
With Family / 
at student 
dormitory 
Participants 
 
Father’s 
Education 
 
Father’s educational 
status  
Education levels were categorized as: 
"Below secondary education" (no formal 
education, primary, or incomplete secondary 
schooling) and "Secondary or higher 
education" (completed secondary school, 
higher secondary, college, or university)      
Count of 
participants 
 
Not 
applicable 
 
 
Below 
Secondary (0-
5 y schooling) 
/ Secondary 
and above(> 5 
y schooling) 
 
Participants 
 
Mother’s 
Education 
Mother’s educational 
status 
Father’s 
Occupation 
Father’s occupational 
status  
Occupational status was self-reported as 
either Formal (salaried or secure jobs) or 
Informal (homemaking, daily wage, or 
insecure work) 
Count of 
participants 
Not 
applicable 
Formal / 
Informal 
Participants 
Mother’s 
Occupation 
Mother’s 
occupational status  

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Number of baseline participants  
The number of baseline participants is the same as the overall number of baseline participants, as 
it includes all individuals who completed baseline data collection and met the data quality criteria. 
Although PSM was later used to create comparable groups for outcome analysis, the baseline 
measures reflect the entire recruited sample before matching. Therefore, no separate or reduced 
sample size is reported in this section. 
 
Baseline Measure Data  
Baseline characteristics were assessed at the time of outcome evaluation for both the intervention 
and control groups. Although data were collected post-intervention, propensity score matching 
was applied to balance pre-existing covariates and reduce selection bias in estimating the treatment 
effect. The Table 7(A and B) present the baseline values for each measure across the intervention 
and control groups, as well as for the total study population. 
Table 7A. Comparison of baseline characteristics between study groups for dysmenorrhea 
outcome 
Variables 
Control 
(n = 238) 
Intervention 
(n = 234) 
Total 
(N = 472) 
Physical activity level   
      Sedentary  
206 (43.6) 
114 (24.2) 
320 (67.8) 
      Active and Athlete  
32 (6.6)  
120 (25.6) 
152 (32.2) 
BMI (kg/m2) 
      Normal weight (18.5-22.9) 
83 (17.6) 
171 (36.2) 
254 (53.8) 
      Underweight ( <18.5) 
44 (9.3) 
37 (7.8) 
81 (17.2) 
      Overweight and obese (>22.9) 
111 (23.5) 
26 (5.5) 
137 (29.0) 
MDD (scoring ≥ 5)    
      No 
153 (32.4) 
96 (20.3) 
249 (52.8) 
      Yes 
85 (18.01) 
138 (29.2) 
223 (47.2) 
Food craving for high fat and sweet food 
       No  
77 (16.3) 
164 (34.8) 
241 (51.1) 

19 
 
 
       Yes 
161 (34.1) 
70 (14.8) 
231 (48.9) 
Skipping breakfast 
       No  
72 (15.5) 
169 (35.8) 
241 (51.1) 
       Yes 
166 (35.2) 
65 (13.8) 
231 (48.9) 
Sleep hours per night 
       ≥ 7 hours  
75 (15.9) 
155 (32.8) 
230 (48.7) 
       < 7 hours  
163 (34.5) 
79 (16.7) 
242 (51.3) 
Frequency of caffeine Intake 
       Infrequent (< 3 times per week) 
65 (13.8) 
157 (33.3) 
222 (47.0) 
       Frequent ≥ 3 times per week) 
173 (36.7) 
77 (16.3) 
250 (53.0) 
Bedtime (hours) 
       Before or at 23:00  
26 (5.5) 
139 (29.5) 
165 (35.0) 
       After 23:00 
212 (44.9) 
95 (20.1) 
307 (65.0) 
Family history of menstrual disorders  
       No  
160 (33.9) 
197 (41.7) 
357 (75.6) 
       Yes 
78 (16.5) 
37 (7.8) 
115 (24.4) 
Age (years) 
        Mean (SD) 
21.9 (1.4) 
21.0 (1.5) 
21.5 (1.5) 
Age at menarche (years)  
        Mean (SD) 
12.1 (1.5) 
13.4 (1.7) 
12.7 (1.7) 
Marital status 
        Never Married  
216 (45.8) 
226 (47.9) 
442 (93.6) 
        Ever married  
22 (4.7) 
8 (1.7) 
30 (6.4) 
Place of residence 
       With Family  
18 (3.8) 
46 (9.8) 
64 (13.6) 
       At student dormitory 
220 (46.6) 
188 (39.8) 
408 (86.4) 
Father’s educational status 
      Secondary and above (> 5 y schooling) 
188 (39.9) 
217 (46.0) 
405 (85.8) 
      Below secondary (0-5 y schooling) 
50 (10.6) 
17 (3.6) 
67 (14.2) 
Mother’s educational status 
       Secondary and above (>5 y schooling) 
176 (37.3) 
195 (41.3) 
371 (78.6) 
       Below secondary (0-5 y schooling) 
62 (13.1) 
39 (8.3) 
101 (21.4) 
Father’s occupational status 
       Formal occupation 
138 (29.2) 
144 (30.5) 
282 (59.8) 
       Informal occupation 
100 (21.2) 
90 (19.0) 
190 (40.2) 
Mother’s occupational status   
       Formal occupation 
66 (14.0) 
44 (9.3) 
110 (23.3) 
       Informal occupation 
172 (36.4) 
190 (40.3) 
362 (76.7) 
 

20 
 
 
Table 7B. Distribution of baseline characteristics among intervention and control groups for PMS 
and MI outcomes  
 
Variables 
Control 
 (n = 228) 
Intervention 
(n = 228) 
Total  
(N = 456) 
Physical activity level 
      Sedentary  
197 (43.3) 
112 (24.6) 
309 (67.8) 
      Active and Athlete  
31 (6.8)  
116 (25.4) 
147 (32.2) 
BMI (kg/m2) 
      Normal weight (18.5 – 22.9) 
80 (17.5) 
167 (36.6) 
247 (54.2) 
      Underweight (< 18.5) 
42 (9.2) 
37 (8.1) 
79 (17.3) 
      Overweight/obese (> 22.9) 
106 (23.2) 
24 (5.2) 
130 (28.5) 
MDD (scoring ≥ 5)    
      No 
145 (31.8) 
93 (20.4) 
238 (52.2) 
      Yes 
83 (18.2) 
135 (29.6) 
218 (47.8) 
Food craving for high fat and sweet food 
       No  
75 (16.5) 
159 (34.9) 
234 (51.3) 
       Yes 
153 (33.5) 
69 (15.1) 
222 (48.7) 
Skipping breakfast 
       No  
67 (14.7) 
165 (36.0) 
232 (50.9) 
       Yes 
161 (35.3) 
63 (14.0) 
224 (49.1) 
Sleep hours per night 
       ≥ 7 hours  
71 (15.6) 
151 (33.1) 
222 (48.7) 
       < 7 hours  
157 (34.4) 
77 (16.9) 
234 (51.3) 
Frequency of caffeine Intake 
       Infrequent (< 3 times per week) 
60 (13.1) 
152 (33.3) 
212 (46.5) 
       Frequent  (≥ 3 times per week) 
168 (36.9) 
76 (16.7) 
244 (53.5) 
Bedtime (hours) 
       23:00  and before 
24 (5.3) 
137 (30.0) 
161 (35.3) 
       After 23:00 
204 (44.7) 
91 (20.0) 
295 (64.7) 
Family history of menstrual disorders  
       No  
151 (33.1) 
191 (41.9) 
342 (75.0) 
       Yes 
77 (16.9) 
37 (8.1) 
114 (25.0) 
Age (years) 
        Mean (SD) 
22.0 (1.4) 
21.0 (1.5) 
21.5 (1.5) 
Age at menarche (years)  
        Mean (SD) 
12.2 (1.5) 
13.4 (1.7) 
12.8 (1.7) 
Marital status 
        Never Married  
206 (45.2) 
221 (48.5) 
427 (93.6) 
        Ever married  
22 (4.8) 
7 (1.5) 
29 (6.4) 
Place of participant’s residence  

21 
 
 
       With family 
17 (3.7) 
44  (9.87) 
61 (13.4) 
       At student dormitory  
 
211 (46.3) 
184 (40.3) 
395 (86.6) 
Father’s educational status 
      Secondary and above (> 5 y schooling) 
180 (39.5) 
212 (46.5) 
392 (86.0) 
      Below secondary (0 – 5 y schooling) 
48 (10.5) 
16 (3.5) 
64 (14.0) 
Mother’s educational status 
      Secondary and above (> 5 y schooling) 
168 (36.8) 
191 (41.9) 
359 (78.7) 
      Below secondary (0 – 5 y schooling) 
60 (13.2) 
37 (8.1) 
97 (21.3) 
Father’s occupational status 
       Formal occupation 
130 (28.5) 
142 (31.1) 
272 (59.6) 
       Informal occupation 
 
98 (21.5) 
86 (18.9) 
184 (40.4) 
Mother’s occupational status 
       Formal occupation 
65 (14.3) 
44 (9.3) 
109 (23.9) 
       Informal occupation 
163 (35.7) 
185 (40.6) 
348 (76.1) 
 
Outcome measures 
Outcome measure information 
In accordance with the study protocol, this section (Table 8) details the predefined primary 
outcomes used to evaluate intervention efficacy. The study focused on three key outcomes: 
dysmenorrhea, PMS and MI. Each was measured during the post-intervention period using 
standardized assessment tools. To support the study’s quasi-experimental design and statistical 
analysis, all outcome variables were recoded as binary indicators.  
Table 8. Summary of outcome measures information  
Data elements 
Dysmenorrhea 
Premenstrual Syndrome 
(PMS) 
Menstrual Irregularity 
(MI) 
Outcome measure 
type 
Primary 
Primary  
Primary  
Outcome measure 
title 
Prevalence of 
Dysmenorrhea 
Prevalence of PMS  
Prevalence of MI 
Outcome measure 
description 
Assessed according to 
Andersch and Milsom 
Premenstrual symptoms were 
assessed using premenstrual 
Menstrual irregularity 
was assessed based on 

22 
 
 
scale (Grades 0 – 3) which 
evaluated the pain intensity 
and its impact on daily 
activities. The scale of pain 
intensity was recoded into 
binary: 0 = No (no pain), 1 
= Yes (any pain: 
mild/moderate/severe). 
symptoms screening tool 
(PSST) and categorized into 
three groups: No/Mild PMS, 
Moderate to Severe PMS, and 
premenstrual dysphoric disorder 
(PMDD). For analysis, these 
were combined into a binary 
variable: 0 = No/Mild PMS and 
1 = Moderate to Severe PMS or 
PMDD 
participants’ self-
reported cycle lengths. 
A cycle was considered 
irregular (coded 1 = 
Yes) if it was shorter 
than 21 days or longer 
than 35 days. Cycles 
within the 21–35 day 
range were classified as 
not irregular (coded 0 = 
No) 
Outcome measure 
time frame 
Participants received three BCC sessions over approximately 6 weeks, followed by 
regular support to encourage behavior change for up to 6 months, with monitoring every 
two months. Final outcomes were assessed about 8 months after enrollment. 
Outcome measure 
data type 
Count of participants 
Count of participants 
Count of participants 
Measure of 
dispersion/precision Not applicable 
Not applicable 
Not applicable 
Category title 
Yes (Dysmenorrhea = 1)/ 
No (Dysmenorrhea = 0) 
Yes (Moderate to Severe 
PMS/PMDD = 1)/ 
No (No/mild PMS = 0) 
Yes (MI = 1)/ 
No (MI = 0) 
Unit of Measure 
Participants 
Participants 
Participants 
 
Group information  
Group title 
1. Intervention Group  
2. Control Group 
Group description 
The intervention group comprised female university students who attended all BCC sessions 
conducted between May 20 and June 30, 2023, followed by a six-month monitoring period that 
included scheduled follow-ups every two months through January 15, 2024. The sessions focused 
on menstrual health education, dietary improvements, and physical activity. At the end of the 

23 
 
 
follow-up, 239 participants completed the outcome assessment. After data cleaning, 234 
participants were included in the final analysis for dysmenorrhea, while 228 with valid and 
complete data were analyzed for PMS and MI outcomes. 
Participants in the control group did not receive the BCC intervention or any related educational 
sessions but were matched with the intervention group based on number and baseline 
characteristics. Of the 249 participants initially enrolled in the control arm, 241 completed the 
outcome assessment interview. After data quality checks, 238 participants were retained for the 
final dysmenorrhea analysis. For the PMS and MI outcomes, 228 participants with complete and 
valid data were included in their respective analyses.  
After propensity score matching, 98 matched participants from each group (n=196) were used for 
the final analysis of each outcome variable, ensuring balance between the groups on key covariates. 
Analysis population information 
This section provides (Table 9) an overview of the analysis populations for each outcome measure, 
including the number of participants at baseline and after propensity score matching. It also 
outlines the methods used to define the final samples included in the analyses.   
 
 
 
 
 

24 
 
 
Table 9. Overview of analysis population by groups for outcome measures  
 
Outcome measure data 
Table 10 represents the outcome measure data for all participants who completed the follow-up 
assessment. Results are shown separately for the intervention and control groups, with each 
outcome reported as the number and percentage of participants. The data reflect the prevalence of 
each specified condition at follow-up, according to group assignment.  
 
 
 
Outcomes 
Group 
Overall number of  
participants analyzed  
Analysis population description 
Dysmenorrhea 
Intervention 
234 
Following initial recruitment and data 
quality verification, 234 participants in 
the intervention group and 238 in the 
control group were eligible for analysis. 
However, Final analyses were 
conducted using 1:1 propensity score 
matching without replacement and a 
caliper of 0.01, yielding a matched 
sample of 196 participants (98 from 
each group). 
Control 
238 
Total 
472 
PMS and MI  
Intervention 
228 
For both PMS and IMC outcome 
measures, 228 participants from each 
group provided valid and complete 
responses for the baseline analysis. 
Following 1:1 propensity score 
matching without replacement (caliper 
= 0.01), 98 participants per group were 
retained, yielding a final matched 
sample of 196. 
Control 
228 
Total 
456 

25 
 
 
Table 10. Prevalence of key menstrual disorders among participants in control and intervention 
groups 
 
Adverse event information  
1. All-cause mortality 
No deaths occurred during the intervention or follow-up period. The intervention was non-
invasive and behavioral in nature. 
2. Serious adverse events 
No serious adverse events were reported or observed. Participants were university students 
who voluntarily enrolled after providing informed consent. The intervention consisted of a 
non-invasive BCC module focused on menstrual health education. Given the educational 
nature and low-risk profile of the study population, no medical or psychological harm was 
expected or detected. 
 
 
 
Outcome variables  
Control 
 (n = 238) 
Intervention 
(n = 234) 
Total  
(N = 472) 
Prevalence of Dysmenorrhea 
       No  
29 (6.1) 
159 (33.7) 
188 (39.8) 
       Yes  
209 (44.3)  
75 (15.9) 
284 (60.2) 
 
Outcome variables  
Control 
 (n = 228) 
Intervention 
(n = 228) 
Total  
(N = 456) 
Prevalence of premenstrual syndrome (PMS)  
       No/Mild PMS  
83 (18.2) 
205 (45.0) 
288 (63.2) 
       Moderate to Severe PMS/PMDD 
145 (31.8) 
23 (5.0) 
168 (36.8) 
Prevalence of Menstrual Irregularity (MI) 
      No (regular) 
118 (25.8) 
93 (20.4) 
323 (70.8) 
      Yes (Irregular) 
205 (45.0) 
23 (5.0) 
218 (29.2) 

26 
 
 
3. Other (non-serious) adverse events 
No non-serious adverse events exceeding the 5% frequency threshold were reported. 
Participants were monitored regularly throughout the study. 
Time frame  
Adverse events were monitored throughout the 6-month follow-up phase of the intervention.  
 
Adverse event reporting description 
Adverse events were not estimated due to the non-invasive nature of the behavioral intervention. 
No events were observed or self-reported during the periods of follow-up or impact assessment. 
Collection approach for table default   
Non-Systematic Assessment 
Adverse events were self-reported if any occurred, but no systematic daily assessment was 
employed. 
Group information  
Group title 
1. Intervention Group (participants who received BCC intervention) 
2. Control Group (Participant s who did not received BCC intervention) 
 
 

27 
 
 
Group description  
The intervention group attended BCC sessions on menstrual health, diet, and physical activity from 
May to June 2023, with bi-monthly follow-ups through January 2024. The control group did not 
receive any educational intervention. The dysmenorrhea outcome analysis included 234 
participants from the intervention group and 238 from the control group. In the case of PMS and 
MI, 228 participants with complete and valid data were analyzed per group. To ensure baseline 
comparability, final analyses included 98 matched participants per group (n=196) after propensity 
score matching.  
Total number affected by all-cause mortality  
 Not applicable as the participants received the non-invasive nature of the behavioral 
intervention.  
Total number at risk for all-cause mortality 
 Not applicable as the participants received the non-invasive nature of the behavioral 
intervention.  
Total number at risk for serious adverse events 
 Not applicable as the participants received the non-invasive nature of the behavioral 
intervention.  
Total number affected by any serious adverse event 
 Not applicable as the participants received the non-invasive nature of the behavioral 
intervention.  
 

28 
 
 
Limitation and caveats  
This quasi-experimental study lacked randomization, which may have introduced residual 
confounding and limited causal inference. About 4% of intervention participants missed sessions 
or follow-up, possibly underestimating the true effect. While the study aimed to reflect real-world 
settings by conducting sessions in academic institutions, potential confounding factors related to 
control group characteristics were not assessed. Dietary intake quantity was not measured, and 24-
hour recalls may have been impacted by recall bias, affecting data accuracy. 
Certain Agreements 
Are all PIs employees of sponsor? 
 Yes: The principal investigator (PI) is an employee of the sponsor 
There were no agreements restricting the principal investigators from discussing, presenting or 
publishing the study results. The study was self-financed without external sponsorship.  
Results point of contact 
Name or official title: Professor Dr. GM Rabiul Islam, principal investigator (PI) of the study 
Organization name: Shahjalal University of Science and Technology, Sylhet, Bangladesh 
Phone: +8801787323944 
Email: rabiat14@yahoo.com 
 
 

29 
 
 
References 
1. Rupe ER, Rodean J, Hurley EA, Miller MK, Boncoeur MD, Masonbrink AR. Menstrual health 
among adolescents and young adults in rural Haiti. Reproductive Health. 2022;19(1):227. doi: 
10.1186/s12978-022-01533-4. 
2. Slap GB. Menstrual disorders in adolescence. Best Pract Res Clin Obstet Gynaecol. 
2003;17(1):75-92. doi: https://doi.org/10.1053/ybeog.2002.0342. PubMed PMID: 12758227; 
PubMed Central PMCID: PMC12758227. 
3. Sen LC, Jahan I, Salekin N, Shourove JH, Rahman M, Uddin MJ, et al. Food craving, vitamin 
A, and menstrual disorders: A comprehensive study on university female students. PloS one. 
2024;19(9):e0310995. 
doi: 
10.1371/journal.pone.0310995 
PubMed 
Central 
PMCID: 
PMCPMC11423980  
4. Andersch B, Milsom I. An epidemiologic study of young women with dysmenorrhea. American 
journal 
of obstetrics 
and gynecology. 1982;144(6):655-60. Epub 1982/11/15. doi: 
https://doi.org/10.1016/0002-9378(82)90433-1. PubMed PMID: 7137249. 
5. Steiner M, Macdougall M, Brown E. The premenstrual symptoms screening tool (PSST) for 
clinicians. Archives of women's mental health. 2003;6(3):203-9. Epub 2003/08/16. doi: 
10.1007/s00737-003-0018-4. PubMed PMID: 12920618. 
6. Ansong E, Arhin SK, Cai Y, Xu X, Wu X. Menstrual characteristics, disorders and associated 
risk factors among female international students in Zhejiang Province, China: a cross-sectional 
survey. BMC women's health. 2019;19:1-10. 
7. Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP. World Health Organization 2020 
guidelines on physical activity and sedentary behaviour. 2020;54(24):1451-62. doi: 
10.1136/bjsports-2020-102955. PubMed PMID: 33239350. 

30 
 
 
8. WHO. Appropriate body-mass index for Asian populations and its implications for policy and 
intervention strategies. Lancet (London, England). 2004;363(9403):157-63. Epub 2004/01/17. doi: 
10.1016/s0140-6736(03)15268-3. PubMed PMID: 14726171. 
9. Hanley-Cook GT, Tung JYA, Sattamini IF. Minimum Dietary Diversity for Women of 
Reproductive Age (MDD-W) Data Collection: Validity of the List-Based and Open Recall 
Methods as Compared to Weighed Food Record. 2020;12(7). doi: 10.3390/nu12072039. PubMed 
PMID: 32659995. 
10. Matsuura Y, Inoue A, Kidani M, Yasui T. Change in appetite and food craving during 
menstrual cycle in young students. International Journal of Nutrition and Metabolism. 
2020;12(2):25-30. doi: https://doi.org/10.5897/IJNAM2019.0264. 
11. Mitsuhashi R, Sawai A, Kiyohara K, Shiraki H, Nakata Y. Factors associated with the 
prevalence and severity of menstrual-related symptoms: A systematic review and meta-analysis. 
International Journal of Environmental Research and Public Health. 2022;20(1):569. 
 
 
 
 
 
 
 
 

31 
 
 
Statistical Analysis Plan (SAP) 
Statistical analysis overview 
Statistical analyses were conducted to evaluate the impact of the BCC intervention on three binary 
outcomes: dysmenorrhea, PMS, and IMC. Categorical variables were summarized as frequencies 
and percentages and analyzed using the chi-square (χ²) test. Continuous variables were presented 
as means with standard deviations and compared using independent t-tests. To adjust for potential 
baseline imbalances between the intervention and control groups, propensity score matching 
(PSM) was carried out using logistic regression. A 1:1 nearest-neighbor matching algorithm was 
applied with a caliper width of 0.01 and without replacement. Post-matching covariate balance 
was assessed using standardized mean differences (with a bias threshold of <10%) and chi-square 
tests. The primary analysis of intervention effects was conducted using conditional logistic 
regression on the matched sample. To validate the findings, bivariate and multivariate logistic 
regression analyses were also performed on the unmatched dataset. Additionally, sensitivity 
analyses were conducted to ensure the robustness and consistency of the results, including 
covariate balance diagnostics, estimation of the average treatment effect (ATE) and the average 
treatment effect on the treated (ATT), and Bayesian logistic regression on the matched sample.  
Comparison group selection 
1. Intervention Group (received BCC module) 
2. Control Group (did not receive BCC module) 
 

32 
 
 
Type of statistical test: Superiority 
 Comments: The analyses were designed to assess whether the BCC intervention group had 
superior outcomes compared to the control group using fixed-effect models on matched 
pairs. Power calculations were based on expected reductions in outcome prevalence. 
Statistical test of hypothesis 
Conditional logistic regression was used to estimate the odds of binary outcomes between 
intervention and control groups after matching.  
 P-Value: < 0.05  
 Comments (P-Value): A p-value < 0.05 was considered statistically significant. No 
adjustments for multiple comparisons were made. Results were considered statistically 
significant at p < 0.05. 
 Method: Chi-squared, t-test, regression (logistic),  conditional logistic regression 
 Comments (Method): Pre- and post-PSM tests used Pearson’s chi-square; conditional 
logistic regression applied to matched data; bivariate and multivariate logistic regression 
used for robustness checks 
Method of Estimation 
 Estimation Parameter: Odds Ratio (OR) 
 Estimated Values: Reported as crude odds ratios (COR) and adjusted odds ratios (AOR). 
Coefficient value was used to estimate ATE and ATT (Table 11).  
 Confidence Interval Level: 95% 
 Number of Sides: 2-sided 
 Lower and upper limit: Reported per outcome (see Table 11)  

33 
 
 
 Parameter Dispersion Type: Standard error of the mean  
 Estimation Comments: Odds ratios compared the intervention group (numerator) to the 
control group (reference) for menstrual outcomes. Odds ratios reflect the likelihood of 
menstrual outcomes in the intervention group relative to the control group. ATE and ATT 
were also estimated using PSM.  
Table 11. Estimated odds ratios from bivariate and multivariable (before matching) as well as 
conditional (after matching) and logistic regression models assessing the impact of the BCC 
module on menstrual health outcomes 
* Indicated chi square value define the level of significance i.e. * p < 0.05, ** p < 0.01, *** p < 0.001 
Other statistical analysis  
Additional scientifically appropriate analyses were conducted to ensure robustness and validity of 
the findings:  
1. Propensity Score Matching (PSM): PSM was used to control for baseline differences 
between the intervention and control groups. Participants were matched 1:1 using nearest-
neighbor matching with a caliper width of 0.01 and without replacement. Covariate balance 
was assessed using standardized mean differences (bias <10%) and post-matching chi-
square tests. 
 
Outcomes 
 
Before matching 
 
After matching 
COR (95% CI) 
AOR (95% CI) 
 
AOR (95% CI) 
 
Dysmenorrhea 
0.07 (0.04, 0.11)*** 
0.13 (0.06, 0.26)*** 
0.13 (0.05, 0.34)*** 
Premenstrual syndrome 
0.07 (0.04, 0.11)*** 
0.13 (0.07, 0.23)*** 
0.12 (0.06, 0.27)*** 
Menstrual Irregularity 
0.12 (0.07, 0.20)*** 
0.26 (0.14, 0.48)*** 
0.21 (0.09, 0.45)*** 

34 
 
 
2. Sensitivity Analyses: To confirm the quality of matching and reduce potential bias, 
covariate balance diagnostics were conducted, including checks for percentage bias 
(<10%), variance ratios (acceptable range: 0.5–2.0), and visual inspection via kernel 
density plots to ensure common support. Bayesian logistic regression was also applied to 
estimate the Log Bayes Factor, comparing models with and without the intervention to 
assess the strength and consistency of effects. 
3. Alternative Estimates of Treatment Effect: In addition to logistic regression models, the 
ATE an ATT were calculated (Table 12). These estimates served as supplementary 
measures and supported the stability of intervention effects across multiple analytical 
approaches. 
Table 12. Estimated treatment effect of the BCC intervention on menstrual health outcomes 
via propensity score matching technique 
 
Outcomes 
Average treatment effect (ATE)  
Average treatment effect  
on the treated (ATT) 
Coefficient  
(95% CI) 
p-value 
Coefficient  
(95% CI) 
p-value 
Dysmenorrhea  
−0.23 (−0.35, −0.11) 
p < 0.001*** −0.27 (−0.40, −0.13) 
p < 0.001*** 
Premenstrual syndrome (PMS) 
−0.39 (−0.52, −0.25) 
p < 0.001*** −0.42 (−0.57, −0.26) 
p < 0.001*** 
Menstrual irregularity (MI) 
−0.30 (−0.41, −0.18) 
p < 0.001*** −0.31 (−0.45, −0.16) 
p < 0.001*** 
* Indicated chi square value define the level of significance i.e. * p < 0.05, ** p < 0.01, *** p < 0.001 
 
 
 
 
 
 
 

35 
 
 
Informed Consent Form (ICF) 
Research project title: Behavioral change communication intervention in menstrual disorder 
management among female university students in Bangladesh 
Objective of the study: to evaluate the effectiveness of a structured behavior change 
communication intervention designed to improve menstrual health among female university 
students in Bangladesh.  
(The interviewer will introduce herself and take consent of the interviewee before commencing the session) 
 
Introductory statement  
My name is……………. I am currently working for Mr. Liton Chandra Sen, Associate Professor 
at the Faculty of Nutrition and Food Science, Patuakhali Science and Technology University. I 
have been assigned as an interviewer for the aforementioned PhD project, conducted under the 
Department of Food Engineering and Tea Technology at Shahjalal University of Science and 
Technology.  Therefore, I kindly request your permission to conduct the interview, which typically 
takes about 15–20 minutes. We assure you that your identity will not be disclosed in any reports 
derived from this interview. Your confidentiality will be strictly maintained. You may skip any 
question or stop the interview at any time. With your consent, I would like to take written notes 
during the interview.  
What will you need to do if you agree to participate? 
As a selected respondent, your valuable input on a few key issues is requested. If any question 
makes you feel uncomfortable, you are free to skip it or not respond. 
 

36 
 
 
Risks, Benefits, confidentiality and compensation for participating 
There are no risks to participating. Your input will support Mr. Sen’s PhD research and help 
improve national reproductive health programs for young adults. All information will remain 
strictly confidential and used only for research by authorized personnel. Your participation in this 
study is completely voluntary and offers no financial compensation. There is no pressure or 
obligation to take part. 
Right to refuse or withdraw 
This study has been approved by the Ethical Approval Committee at Shahjalal University of Science and 
Technology. Participation is voluntary, and you can skip questions or withdraw at any time.  
Who do I contact if I have a question or problem? 
 If you wish to know more about your rights as a participant in this study you may write Mr. Liton 
Chadra Sen, Associate Professor, Department of Community Health and Hygiene, Patuakhali 
Science and Technology University, Dumki, patuakhali-8602, email- liton.sen@pstu.ac.bd, 
mobile no. +8801717504808. If you have further questions regarding the nature of this study you 
may also contact Professor Dr. G.M. Rabiul Islam, Department of Food Engineering and Tea 
Technology, 
Shahajalal 
University 
of 
Science 
and 
Technology, 
Sylhet, 
email-  
rabiat14@yahoo.com, phone: 880 821 713 850 extn.242 (office); Cell: +88 01787323944. 
Do you have any questions about the interview? 
May we begin now? If so, please read and sign the consent form, and keep a copy for your records. 
 
 
 

37 
 
 
Consent to publication 
This is to state that I give my full permission for the publication, reproduction, broadcast and other 
use of identifiable details, which can include case history and/or details within the questionnaires  
to be published in any Journal and Article. I confirm that I have seen and been given the 
opportunity to read the methodology to be published by any journal.  
 
I understand that the published article may be available in both print and on the internet, and will 
be available to a broader audience through marketing channels and other third parties. Therefore, 
anyone can read material published in the Journal. I understand that readers may include not only 
public health professionals and scholarly researchers but also journalists and general members of 
the public. I also understand that the information will be published without my personal details 
and every attempt will be made to ensure anonymity. 
 
I declare, in consequence of granting this permission, that I have no claim on ground of breach of 
confidence or any other ground in any legal system against the authors and its agents, publishers, 
successors and assigns in respect of such use of the collected information. 
 
Participant’s Name: ………………………………… Signature ………………..  Date: ………… 
 
Name of person obtaining consent: ………………… Signature: ……………… Date: ………..  
(Individual who has been designated to obtain consent) 
To be counter-signed and dated electronically for telephone interviews or in the presence of the participant 
for face to face interviews.