Improving Menstrual Health Through BCC Among Bangladeshi University Students

NCT07047222 | Completed

• 1 other identifier: AST/002/258
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dysmenorrhea; Premenstrual Syndrome-PMS; Menstrual Irregularity

Keywords

Menstrual Health; Menstrual disorders; Behavior Change Communication; Lifestyle Intervention; Female University Students; BCC Module; Dietary Diversity; Physical Activity; Bangladesh; Propensity Score Matching (PSM)

Outcome Measures

Primary Outcomes (3)

• 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).

  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

  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)

  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.

Study Arms (2)

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.

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.

Interventions

Behavioral change communication (BCC) module BEHAVIORAL

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.

Also known as: BCC module

Intervention group

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahjalal University of Science and Technology: lead

Study Sites (1)

Patuakhali Science and technology University

Dumki, Patuakhali, 8602, Bangladesh

Location

Related Publications (10)

• 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.

  PMID: 36612891 BACKGROUND

• Hanley-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.

  PMID: 32659995 BACKGROUND

• WHO 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.

  PMID: 14726171 BACKGROUND

• Bull 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.

  PMID: 33239350 BACKGROUND

• 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 Womens Health. 2019 Feb 18;19(1):35. doi: 10.1186/s12905-019-0730-5.

  PMID: 30777053 BACKGROUND

• Steiner 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.

  PMID: 12920618 BACKGROUND

• Andersch 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.

  PMID: 7137249 BACKGROUND

• Sen 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.

  PMID: 39321166 BACKGROUND

• Slap GB. Menstrual disorders in adolescence. Best Pract Res Clin Obstet Gynaecol. 2003 Feb;17(1):75-92. doi: 10.1053/ybeog.2002.0342.

  PMID: 12758227 BACKGROUND

• Rupe 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.

  PMID: 36539795 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Premenstrual Syndrome; Menstruation Disturbances; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• GM Rabiul Islam, PhD

  Shahjalal University of Science and Technology Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This was a quasi-experimental study with non-random recruitment conducted through campus outreach and voluntary registration. Interested students who wished to participate in BCC module were invited to register by providing their name, contact number, room number, residence name, and university. To form the control group, an equal number of students from the same residences who did not participate in the BCC sessions were identified and listed. Since participation in the intervention was voluntary and based on personal interest, random sampling was neither feasible nor aligned with the study objectives. Therefore, participants were selected using purposeful, non-random sampling based on their characteristics and willingness to participate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator (PI) of the study

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 2, 2025
• Study Start: May 20, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD will become available 6 months after publication of this study results in a peer-reviewed journal and will remain accessible for a duration of 3 years. During this availability period, qualified researchers affiliated with academic, governmental, or non-profit public health institutions may request access to the dataset to verify findings, conduct secondary analyses, or contribute to meta-analyses focused on menstrual health outcomes (e.g., dysmenorrhea, PMS, irregular menstrual cycles) among young adult female populations.
• Access Criteria: Qualified researchers may request access to the data for academic, non-commercial purposes. Requests must include a detailed research proposal and will be reviewed by the principal investigator and ethics committee. Access will be granted only if the proposal is methodologically sound, aligns with the original consent, and ensures participant confidentiality. Approved researchers must sign a data use agreement to protect participant privacy and comply with all ethical and legal data use requirements.

Locations

BA (1)