DysmenorrheaNCT07047222
Improving Menstrual Health Through BCC Among Bangladeshi University Students
A study testing Behavioral change communication (BCC) module in people with Dysmenorrhea and Premenstrual Syndrome-PMS, run by Shahjalal University of Science and Technology at 1 site in Bangladesh.
Trial summary
This study evaluated the effectiveness of a Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. The intervention focused on three outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI), promoting a… Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Premenstrual Syndrome-PMS, Menstrual Irregularity
- What is being tested?
- Behavioral change communication (BCC) module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 May 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female university students aged 19 to 25 years, based on self-reported age, verified through enrollment records. The young adult female of this age range was selected to capture reproductive-aged participants most likely to experience menstrual disorders.
- Currently enrolled as full-time undergraduate students at one of the following selected public universities in Bangladesh: Patuakhali Science and Technology University (PSTU), Barisal University (BU), or Khulna University (KU). These institutions were selected based on logistical feasibility and representativeness of the target population.
- Willing and able to provide written informed consent after being fully informed of the study's purpose, procedures, potential risks, and benefits, and their rights as participants. Informed consent was obtained in accordance with ethical guidelines of SUST Research Ethics Board (SREB).
- Available and committed to participating in all phases of the study, including all three intervention sessions (BCC module), bimonthly follow-up over a six-month period (July 2023 to January 2024) and in evaluation of the intervention's effectiveness.
- Have regular access to a mobile phone, email, or another reliable means of communication to receive reminders, updates, and follow-up contacts related to intervention sessions and data collection.
- Able to comprehend and respond to study instructions and questionnaires in either Bengali or English, ensuring accurate data collection and meaningful engagement in the intervention.
- Not currently pregnant or breastfeeding, as confirmed during initial screening, to ensure hormonal stability and comparability across participants.
Who cannot join
- Currently receiving treatment with hormonal contraceptives, hormone replacement therapy, or any other medication specifically prescribed to manage menstrual disorders (e.g., dysmenorrhea, premenstrual syndrome, or irregular menstrual cycle).
- History of major abdominal or gynecological surgery (e.g., hysterectomy, oophorectomy, or myomectomy) that may affect menstrual function or reproductive physiology.
- Clinical diagnosis of chronic gynecological conditions, including but not limited to polycystic ovary syndrome (PCOS), endometriosis, or uterine fibroids.
- Diagnosed with chronic endocrine disorders such as thyroid disease, adrenal disorders, or diabetes mellitus, which may affect menstrual health.
- Pregnant, planning to conceive, or currently breastfeeding at the time of enrollment.
- Participation in another clinical trial or intervention study related to reproductive health, dietary habit, or physical activity.
- Presence of any diagnosed psychiatric illness or cognitive impairment that could interfere with participation in educational sessions or accurate reporting of menstrual symptoms.
- Refusal or inability to provide informed consent or commit to the follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Patuakhali Science and technology University
Dumki, Patuakhali, 8602
About this study
Official title: Behavioral Change Communication Intervention in Menstrual Disorder Management Among Female University Students in Bangladesh
This study evaluated the effectiveness of a Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. The intervention focused on three outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI), promoting a non-pharmacological, sustainable approach through behavioral and lifestyle changes.
Three structured educational sessions on menstrual health, healthy diet, and physical activity were delivered by trained female educators between May 20 and June 30, 2023, at Patuakhali Science and Technology University, Barishal University, and Khulna University. Participation was voluntary. Reinforcement follow-ups were conducted every two months for six months.
Read more
A quasi-experimental design was employed. Post-intervention data were collected from February to March 2024. Based on sample size calculations assuming a 30% reduction in disorder prevalence, 498 students (249 per group) were initially enrolled. After exclusions, 234 intervention and 238 control participants were analyzed for dysmenorrhea; 228 per group for PMS and MI. Propensity score matching (1:1, caliper 0.01, no replacement) yielded 98 matched participants per group for final analysis.
Eligible participants were female students aged ≥19 years, residing in university dormitories. Data collection used validated Bengali-language, interviewer-administered questionnaires, based on relevant literature and menstrual health IEC materials. Trained female enumerators ensured data quality and participant comfort.
Primary outcomes were: (1) Dysmenorrhea, measured by the Andersch and Milsom score (dichotomized Yes/No); (2) PMS, assessed using the Premenstrual Symptoms Screening Tool, with no/mild PMS and moderate to severe PMS/PMDD as the outcome; (3) MI, defined as self-reported menstrual cycles <21 or >35 days. The treatment variable was BCC exposure (Yes/No).
Covariates included physical activity, BMI, dietary diversity (DDS ≥5), food cravings, breakfast skipping, sleep duration, caffeine use, bedtime, family history of menstrual disorders, age at menarche, marital status, residence, and parental education and occupation.
Baseline differences were assessed using descriptive statistics, chi-square, and t-tests. Conditional logistic regression estimated intervention effects on matched data. Sensitivity analyses (ATE, ATT, balance diagnostics, Bayesian logistic regression) supported the robustness of results.
Read the detailed description
This study aimed to assess the effectiveness of a structured Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. Specifically, it targeted three key menstrual health outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI). The overarching goal was to promote a sustainable, non-pharmacological strategy for managing common menstrual disorders by fostering positive lifestyle and behavioral changes-such as healthier eating habits, increased physical activity, and greater awareness about menstrual health.
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 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 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 enhance retention and adherence, follow-up visits were conducted bi-monthly for six months after the intervention to reinforce key messages and address participant questions or barriers to behavior change. Post-intervention data collection was carried out between February and March 2024.
Participants were eligible if they were female students aged 19 years or older, residing full-time in university dormitories, and not currently taking hormonal treatments or diagnosed with chronic illnesses affecting menstruation. Recruitment occurred through record book of student dormitories at each university and student networks. Informed written consent was obtained prior to participation.
Data were collected through interviewer-administered questionnaires, adapted and validated in Bengali for cultural relevance and comprehension. Instruments were based on existing literature and government-endorsed information, education, and communication (IEC) materials on menstrual health. All interviews were conducted by trained female enumerators to ensure a comfortable and respectful environment for participants.
The sample size was calculated to detect a 30% reduction in the prevalence of menstrual disorders, with 80% statistical power and a 95% confidence interval, accounting for an anticipated dropout rate. Initially, 498 participants were recruited-249 each in the intervention and control groups. After excluding individuals with missing follow-up data or incomplete attendance, 234 participants in the intervention group and 238 in the control group were included in the analysis for dysmenorrhea. For PMS and MI outcomes, 228 participants per group had valid data.To control for potential confounding, 1:1 propensity score matching (PSM) was conducted using nearest-neighbor matching with a caliper of 0.01 and without replacement. Matching was based on baseline characteristics to ensure statistical equivalence between groups. After matching, a balanced analytical sample of 196 participants (98 in each group) was retained for all outcome analyses.
Among all the primary outcomes, dysmenorrhea was assessed using the Andersch and Milsom 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). 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.
The primary exposure variable was participation in the BCC intervention, coded as yes (intervention group) or no (control group).
The covariates included physical activity, obesity, dietary habits, lifestyle factors, and socio-demographic characteristics. Physical activity was classified according to WHO guidelines 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: (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 evaluated through 24-hour dietary recall using FAO's Minimum Dietary Diversity for Women (MDD-W) scoring system, with scores ≥5 indicating adequate diversity was collected using a five-day 24-hour recall method, and dietary diversity score (DDS) was calculated following FAO guidelines. Lifestyle-related covariates included food cravings for high-fat or sweet foods, skipping breakfast, sleep duration, bedtime and caffeine intake. 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 analysis was performed using Stata 17. The following steps were undertaken:
- Descriptive statistics summarized baseline demographic and behavioral characteristics. Chi-square (χ²) tests were used for categorical variables, and independent-sample t-tests for continuous variables.
- Propensity score matching (PSM) was conducted using logistic regression to estimate the probability of receiving the intervention, based on the identified covariates. Nearest-neighbor matching (1:1) with a caliper width of 0.01 (no replacement) was applied. Balance between groups post-matching was assessed using standardized mean differences (SMD), with values <10% indicating adequate balance.
- Primary analyses of intervention effects were conducted using conditional logistic regression on the matched sample to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome.
- To confirm the robustness of the findings, bivariate and multivariate logistic regression analyses were also performed on the unmatched sample, adjusting for covariates.
- Sensitivity analyses were carried out to assess the stability of the results, including: covariate balance diagnostics (before and after matching); estimation of Average Treatment Effect (ATE) and Average Treatment Effect on the Treated (ATT); Bayesian logistic regression, including log Bayes factor interpretation, to evaluate model fit and strength of evidence for intervention effects. However, All statistical tests were two-sided, with a significance level set at p < 0.05.
- Being tested
- Behavioral change communication (BCC) module
- Keywords
- Menstrual Health, Menstrual disorders, Behavior Change Communication, Lifestyle Intervention, Female University Students, BCC Module, Dietary Diversity, Physical Activity, Bangladesh, Propensity Score Matching (PSM)
- Medical subject headings
- Dysmenorrhea, Premenstrual Syndrome, Menstruation Disturbances, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral change communication (BCC) moduleBehavioural
Also called BCC module
The behavior change communication (BCC) module was designed to enhance awareness and promote effective management of menstrual disorders through structured lifestyle and behavioral guidance. It consisted of three 1-hour sessions: (1) education on menstrual disorders and related risk factors; (2) healthy dietary practices; and (3) physical activity (including yoga) and other lifestyle improvements. Sessions were held from May 20 to June 30, 2023, at three public universities in Bangladesh and were delivered by trained female educators. All session dates were approved by university authorities. Activities included interactive presentations, yoga demonstrations, pamphlet distribution, quizzes, and gift giveaways. To reinforce and support behavior change, follow-up visits were conducted every two months from July 15, 2023, to January 15, 2024.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Female university students who voluntarily registered for the structured BCC module formed the intervention group. The module comprised three interactive sessions that combined educational presentations, yoga demonstrations, distribution of informative pamphlets, quiz-based learning, and the provision of small rewards to encourage active engagement. To support lasting behavior change and address any ongoing challenges, follow-up sessions were conducted every two months. Receives: Behavioral: Behavioral change communication (BCC) module |
| Control group | No intervention | The Control group consisted of female students from the same universities who did not receive any educational session of BCC module or follow-up during the intervention period. 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 intervention, this group served as the matched comparison group for evaluating the effectiveness of the BCC module on menstrual health outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Dysmenorrhea
Dysmenorrhea pain was evaluated using a four-point grading scale that assessed both the severity of pain and its interference with the daily activities: Grade 0 indicated no pain, Grade 1 mild pain, Grade 2 moderate pain, and Grade 3 severe pain. For analytical purposes, this scale was dichotomized into a binary variable, where "0" represented the absence of pain (Grade 0), and "1" indicated the presence of any level of pain (Grades 1 to 3: mild, moderate, or severe).
Measured: 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.
Prevalence of Premenstrual syndrome (PMS)
Premenstrual symptoms were assessed using premenstrual 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
Measured: Each participant received three BCC sessions over 6 weeks, followed by behavior change support and follow-up for 6 months. The final outcome evaluation was performed approximately 8 months after enrollment.
Prevalence of Menstrual Irregularity (MI)
Menstrual cycle irregularity was assessed based on 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)
Measured: Each participant completed the BCC sessions over approximately 6 weeks and followed by 6 months of support to encourage behavior change. The outcomes were assessed about 8 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start20 May 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The BCC module aimed to enhance awareness and promote effective management of menstrual disorders through structured guidance on lifestyle and behavioral changes. It included three sessions: the first covered menstrual disorders and their associated risk factors, the second focused on dietary habits, and the third addressed physical activity (including yoga) and other lifestyle factors. Sessions were conducted from May 20 to June 30, 2023, at PSTU, BU, and KU in Bangladesh by two trained female educators. Informed consent was obtained from interested participants. Session dates were approved by university authorities and included presentations, yoga demonstrations, pamphlet distribution, quizzes, and gifts. Participants were followed up every two months from July 15, 2023, to January 15, 2024, to support behavior change. A quasi-experimental post-evaluation (Feb-Mar 2024) used dormitory records and propensity score matching to compare outcomes with a control group.
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahjalal University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.M. Rabiul Islam, Shahjalal University of Science and Technology
- Investigators
- GM Rabiul Islam, PhD, Principal investigator, Shahjalal University of Science and Technology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047222
- Sponsor's protocol ID
- AST/002/258
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary findings published from this study will be made available to qualified academic or public health researchers upon reasonable request. Shared data will include demographic characteristics and post-intervention outcomes on menstrual health (e.g., dysmenorrhea, premenstrual symptoms, irregular menstrual cycle); socio-demographic variables (e.g., age at menarche, residence, marital status, parental education/occupation, family history of menstrual disorders); lifestyle factors (e.g., physical activity, BMI, dietary diversity, food cravings, caffeine intake, sleep, bedtime); and group assignment (intervention vs. control). Associated data dictionaries and coding manuals will be provided. The IPD will be fully de-identified in accordance with data protection standards to ensure participant confidentiality. The goal is to support reproducibility, meta-analyses, and further research on menstrual health interventions.
Publications
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. Int J Environ Res Public Health. 2022 Dec 29;20(1):569. doi: 10.3390/ijerph20010569.
PubMed 36612891Hanley-Cook GT, Tung JYA, Sattamini IF, Marinda PA, Thong K, Zerfu D, Kolsteren PW, Tuazon MAG, Lachat CK. 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. Nutrients. 2020 Jul 9;12(7):2039. doi: 10.3390/nu12072039.
PubMed 32659995WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.
PubMed 14726171Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Ansong 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 Womens Health. 2019 Feb 18;19(1):35. doi: 10.1186/s12905-019-0730-5.
PubMed 30777053Steiner M, Macdougall M, Brown E. The premenstrual symptoms screening tool (PSST) for clinicians. Arch Womens Ment Health. 2003 Aug;6(3):203-9. doi: 10.1007/s00737-003-0018-4.
PubMed 12920618Andersch B, Milsom I. An epidemiologic study of young women with dysmenorrhea. Am J Obstet Gynecol. 1982 Nov 15;144(6):655-60. doi: 10.1016/0002-9378(82)90433-1.
PubMed 7137249Sen LC, Jahan I, Salekin N, Shourove JH, Rahman M, Uddin MJ, Zhang C, H Hamer D, Islam GMR. Food craving, vitamin A, and menstrual disorders: A comprehensive study on university female students. PLoS One. 2024 Sep 25;19(9):e0310995. doi: 10.1371/journal.pone.0310995. eCollection 2024.
PubMed 39321166Slap GB. Menstrual disorders in adolescence. Best Pract Res Clin Obstet Gynaecol. 2003 Feb;17(1):75-92. doi: 10.1053/ybeog.2002.0342.
PubMed 12758227Rupe ER, Rodean J, Hurley EA, Miller MK, Boncoeur MD, Masonbrink AR. Menstrual health among adolescents and young adults in rural Haiti. Reprod Health. 2022 Dec 20;19(1):227. doi: 10.1186/s12978-022-01533-4.
PubMed 36539795
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Change Communication Intervention in Menstrual Disorder Management Among Female University Students in Bangladesh
- ClinicalTrials.gov ID
- NCT07047222
- Acronym / sponsor ID
- AST/002/258
- Keywords
- Menstrual Health, Menstrual disorders, Behavior Change Communication, Lifestyle Intervention, Female University Students, BCC Module, Dietary Diversity, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Shahjalal University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effectiveness of a Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. The intervention focused on three outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI), promoting a non-pharmacological, sustainable approach through behavioral and lifestyle changes.
Three structured educational sessions on menstrual health, healthy diet, and physical activity were delivered by trained female educators between May 20 and June 30, 2023, at Patuakhali Science and Technology University, Barishal University, and Khulna University. Participation was voluntary. Reinforcement follow-ups were conducted every two months for six months.
A quasi-experimental design was employed. Post-intervention data were collected from February to March 2024. Based on sample size calculations assuming a 30% reduction in disorder prevalence, 498 students (249 per group) were initially enrolled. After exclusions, 234 intervention and 238 control participants were analyzed for dysmenorrhea; 228 per group for PMS and MI. Propensity score matching (1:1, caliper 0.01, no replacement) yielded 98 matched participants per group for final analysis.
Eligible participants were female students aged ≥19 years, residing in university dormitories. Data collection used validated Bengali-language, interviewer-administered questionnaires, based on relevant literature and menstrual health IEC materials. Trained female enumerators ensured data quality and participant comfort.
Primary outcomes were: (1) Dysmenorrhea, measured by the Andersch and Milsom score (dichotomized Yes/No); (2) PMS, assessed using the Premenstrual Symptoms Screening Tool, with no/mild PMS and moderate to severe PMS/PMDD as the outcome; (3) MI, defined as self-reported menstrual cycles <21 or >35 days. The treatment variable was BCC exposure (Yes/No).
Covariates included physical activity, BMI, dietary diversity (DDS ≥5), food cravings, breakfast skipping, sleep duration, caffeine use, bedtime, family history of menstrual disorders, age at menarche, marital status, residence, and parental education and occupation.
Baseline differences were assessed using descriptive statistics, chi-square, and t-tests. Conditional logistic regression estimated intervention effects on matched data. Sensitivity analyses (ATE, ATT, balance diagnostics, Bayesian logistic regression) supported the robustness of results.
Detailed description
This study aimed to assess the effectiveness of a structured Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. Specifically, it targeted three key menstrual health outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI). The overarching goal was to promote a sustainable, non-pharmacological strategy for managing common menstrual disorders by fostering positive lifestyle and behavioral changes-such as healthier eating habits, increased physical activity, and greater awareness about menstrual health.
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 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 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 enhance retention and adherence, follow-up visits were conducted bi-monthly for six months after the intervention to reinforce key messages and address participant questions or barriers to behavior change. Post-intervention data collection was carried out between February and March 2024.
Participants were eligible if they were female students aged 19 years or older, residing full-time in university dormitories, and not currently taking hormonal treatments or diagnosed with chronic illnesses affecting menstruation. Recruitment occurred through record book of student dormitories at each university and student networks. Informed written consent was obtained prior to participation.
Data were collected through interviewer-administered questionnaires, adapted and validated in Bengali for cultural relevance and comprehension. Instruments were based on existing literature and government-endorsed information, education, and communication (IEC) materials on menstrual health. All interviews were conducted by trained female enumerators to ensure a comfortable and respectful environment for participants.
The sample size was calculated to detect a 30% reduction in the prevalence of menstrual disorders, with 80% statistical power and a 95% confidence interval, accounting for an anticipated dropout rate. Initially, 498 participants were recruited-249 each in the intervention and control groups. After excluding individuals with missing follow-up data or incomplete attendance, 234 participants in the intervention group and 238 in the control group were included in the analysis for dysmenorrhea. For PMS and MI outcomes, 228 participants per group had valid data.To control for potential confounding, 1:1 propensity score matching (PSM) was conducted using nearest-neighbor matching with a caliper of 0.01 and without replacement. Matching was based on baseline characteristics to ensure statistical equivalence between groups. After matching, a balanced analytical sample of 196 participants (98 in each group) was retained for all outcome analyses.
Among all the primary outcomes, dysmenorrhea was assessed using the Andersch and Milsom 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). 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.
The primary exposure variable was participation in the BCC intervention, coded as yes (intervention group) or no (control group).
The covariates included physical activity, obesity, dietary habits, lifestyle factors, and socio-demographic characteristics. Physical activity was classified according to WHO guidelines 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: (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 evaluated through 24-hour dietary recall using FAO's Minimum Dietary Diversity for Women (MDD-W) scoring system, with scores ≥5 indicating adequate diversity was collected using a five-day 24-hour recall method, and dietary diversity score (DDS) was calculated following FAO guidelines. Lifestyle-related covariates included food cravings for high-fat or sweet foods, skipping breakfast, sleep duration, bedtime and caffeine intake. 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 analysis was performed using Stata 17. The following steps were undertaken:
- Descriptive statistics summarized baseline demographic and behavioral characteristics. Chi-square (χ²) tests were used for categorical variables, and independent-sample t-tests for continuous variables.
- Propensity score matching (PSM) was conducted using logistic regression to estimate the probability of receiving the intervention, based on the identified covariates. Nearest-neighbor matching (1:1) with a caliper width of 0.01 (no replacement) was applied. Balance between groups post-matching was assessed using standardized mean differences (SMD), with values <10% indicating adequate balance.
- Primary analyses of intervention effects were conducted using conditional logistic regression on the matched sample to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome.
- To confirm the robustness of the findings, bivariate and multivariate logistic regression analyses were also performed on the unmatched sample, adjusting for covariates.
- Sensitivity analyses were carried out to assess the stability of the results, including: covariate balance diagnostics (before and after matching); estimation of Average Treatment Effect (ATE) and Average Treatment Effect on the Treated (ATT); Bayesian logistic regression, including log Bayes factor interpretation, to evaluate model fit and strength of evidence for intervention effects. However, All statistical tests were two-sided, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The BCC module aimed to enhance awareness and promote effective management of menstrual disorders through structured guidance on lifestyle and behavioral changes. It included three sessions: the first covered menstrual disorders and their associated risk factors, the second focused on dietary habits, and the third addressed physical activity (including yoga) and other lifestyle factors. Sessions were conducted from May 20 to June 30, 2023, at PSTU, BU, and KU in Bangladesh by two trained female educators. Informed consent was obtained from interested participants. Session dates were approved by university authorities and included presentations, yoga demonstrations, pamphlet distribution, quizzes, and gifts. Participants were followed up every two months from July 15, 2023, to January 15, 2024, to support behavior change. A quasi-experimental post-evaluation (Feb-Mar 2024) used dormitory records and propensity score matching to compare outcomes with a control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Behavioral change communication (BCC) moduleFemale university students who voluntarily registered for the structured BCC module formed the intervention group. The module comprised three interactive sessions that combined educational presentations, yoga demonstrations, distribution of informative pamphlets, quiz-based learning, and the provision of small rewards to encourage active engagement. To support lasting behavior change and address any ongoing challenges, follow-up sessions were conducted every two months. |
| Control group | No intervention | –The Control group consisted of female students from the same universities who did not receive any educational session of BCC module or follow-up during the intervention period. 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 intervention, this group served as the matched comparison group for evaluating the effectiveness of the BCC module on menstrual health outcomes. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female university students aged 19 to 25 years, based on self-reported age, verified through enrollment records. The young adult female of this age range was selected to capture reproductive-aged participants most likely to experience menstrual disorders.
- Currently enrolled as full-time undergraduate students at one of the following selected public universities in Bangladesh: Patuakhali Science and Technology University (PSTU), Barisal University (BU), or Khulna University (KU). These institutions were selected based on logistical feasibility and representativeness of the target population.
- Willing and able to provide written informed consent after being fully informed of the study's purpose, procedures, potential risks, and benefits, and their rights as participants. Informed consent was obtained in accordance with ethical guidelines of SUST Research Ethics Board (SREB).
- Available and committed to participating in all phases of the study, including all three intervention sessions (BCC module), bimonthly follow-up over a six-month period (July 2023 to January 2024) and in evaluation of the intervention's effectiveness.
- Have regular access to a mobile phone, email, or another reliable means of communication to receive reminders, updates, and follow-up contacts related to intervention sessions and data collection.
Key exclusion criteria (8 listed)
- Currently receiving treatment with hormonal contraceptives, hormone replacement therapy, or any other medication specifically prescribed to manage menstrual disorders (e.g., dysmenorrhea, premenstrual syndrome, or irregular menstrual cycle).
- History of major abdominal or gynecological surgery (e.g., hysterectomy, oophorectomy, or myomectomy) that may affect menstrual function or reproductive physiology.
- Clinical diagnosis of chronic gynecological conditions, including but not limited to polycystic ovary syndrome (PCOS), endometriosis, or uterine fibroids.
- Diagnosed with chronic endocrine disorders such as thyroid disease, adrenal disorders, or diabetes mellitus, which may affect menstrual health.
- Pregnant, planning to conceive, or currently breastfeeding at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral change communication (BCC) moduleAlso: BCC moduleThe behavior change communication (BCC) module was designed to enhance awareness and promote effective management of menstrual disorders through structured lifestyle and behavioral guidance. It consisted of three 1-hour sessions: (1) education on menstrual disorders and related risk factors; (2) healthy dietary practices; and (3) physical activity (including yoga) and other lifestyle improvements. Sessions were held from May 20 to June 30, 2023, at three public universities in Bangladesh and were delivered by trained female educators. All session dates were approved by university authorities. Activities included interactive presentations, yoga demonstrations, pamphlet distribution, quizzes, and gift giveaways. To reinforce and support behavior change, follow-up visits were conducted every two months from July 15, 2023, to January 15, 2024. | Behavioural | Intervention group |
Primary outcome
Prevalence of Dysmenorrhea
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.
Dysmenorrhea pain was evaluated using a four-point grading scale that assessed both the severity of pain and its interference with the daily activities: Grade 0 indicated no pain, Grade 1 mild pain, Grade 2 moderate pain, and Grade 3 severe pain. For analytical purposes, this scale was dichotomized into a binary variable, where "0" represented the absence of pain (Grade 0), and "1" indicated the presence of any level of pain (Grades 1 to 3: mild, moderate, or severe).
Prevalence of Premenstrual syndrome (PMS)
Time frame: Each participant received three BCC sessions over 6 weeks, followed by behavior change support and follow-up for 6 months. The final outcome evaluation was performed approximately 8 months after enrollment.
Premenstrual symptoms were assessed using premenstrual 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
Prevalence of Menstrual Irregularity (MI)
Time frame: Each participant completed the BCC sessions over approximately 6 weeks and followed by 6 months of support to encourage behavior change. The outcomes were assessed about 8 months after enrollment.
Menstrual cycle irregularity was assessed based on 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 36612891Mitsuhashi 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. Int J Environ Res Public Health. 2022 Dec 29;20(1):569. doi: 10.3390/ijerph20010569.
- Background: PubMed 32659995Hanley-Cook GT, Tung JYA, Sattamini IF, Marinda PA, Thong K, Zerfu D, Kolsteren PW, Tuazon MAG, Lachat CK. 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. Nutrients. 2020 Jul 9;12(7):2039. doi: 10.3390/nu12072039.
- Background: PubMed 14726171WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 30777053Ansong 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 Womens Health. 2019 Feb 18;19(1):35. doi: 10.1186/s12905-019-0730-5.
- Background: PubMed 12920618Steiner M, Macdougall M, Brown E. The premenstrual symptoms screening tool (PSST) for clinicians. Arch Womens Ment Health. 2003 Aug;6(3):203-9. doi: 10.1007/s00737-003-0018-4.
- Background: PubMed 7137249Andersch B, Milsom I. An epidemiologic study of young women with dysmenorrhea. Am J Obstet Gynecol. 1982 Nov 15;144(6):655-60. doi: 10.1016/0002-9378(82)90433-1.
- Background: PubMed 39321166Sen LC, Jahan I, Salekin N, Shourove JH, Rahman M, Uddin MJ, Zhang C, H Hamer D, Islam GMR. Food craving, vitamin A, and menstrual disorders: A comprehensive study on university female students. PLoS One. 2024 Sep 25;19(9):e0310995. doi: 10.1371/journal.pone.0310995. eCollection 2024.
- Background: PubMed 12758227Slap GB. Menstrual disorders in adolescence. Best Pract Res Clin Obstet Gynaecol. 2003 Feb;17(1):75-92. doi: 10.1053/ybeog.2002.0342.
- Background: PubMed 36539795Rupe ER, Rodean J, Hurley EA, Miller MK, Boncoeur MD, Masonbrink AR. Menstrual health among adolescents and young adults in rural Haiti. Reprod Health. 2022 Dec 20;19(1):227. doi: 10.1186/s12978-022-01533-4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary findings published from this study will be made available to qualified academic or public health researchers upon reasonable request. Shared data will include demographic characteristics and post-intervention outcomes on menstrual health (e.g., dysmenorrhea, premenstrual symptoms, irregular menstrual cycle); socio-demographic variables (e.g., age at menarche, residence, marital status, parental education/occupation, family history of menstrual disorders); lifestyle factors (e.g., physical activity, BMI, dietary diversity, food cravings, caffeine intake, sleep, bedtime); and group assignment (intervention vs. control). Associated data dictionaries and coding manuals will be provided. The IPD will be fully de-identified in accordance with data protection standards to ensure participant confidentiality. The goal is to support reproducibility, meta-analyses, and further research on menstrual health interventions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GM Rabiul Islam, PhD principal investigator
Shahjalal University of Science and Technology Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral change communication (BCC) module in people with Dysmenorrhea and Premenstrual Syndrome-PMS, run by Shahjalal University of Science and Technology at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Dysmenorrhea (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07047222, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.