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This trial aims to evaluate the effectiveness of a Behavioral Modification Working (BMW) Toolkit in improving glycemic control and blood pressure among pregnant women diagnosed with both GDM and PIH.
Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) are major contributors to maternal and neonatal morbidity, particularly in low- and middle-income countries. Evidence suggests that lifestyle and self-care interventions focusing on diet, physical activity, and sleep may improve maternal outcomes; however, rigorously designed randomized controlled trials evaluating structured behavioral toolkits in Pakistan are scarce.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMW Toolkit + Routine Antenatal Care | Experimental | Participants receive the Behavioral Modification Working (BMW) Toolkit in addition to routine antenatal care. The intervention includes 7-8 structured sessions delivered by a trained health educator focusing on dietary modification, physical activity, sleep hygiene, and self-care practices during pregnancy. |
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| Routine Antenatal Care Alone | Active Comparator | Participants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Modification Working (BMW) Toolkit | Behavioral | Structured behavioral intervention consisting of 7-8 sessions delivered by a trained health educator focusing on dietary modification, physical activity promotion, sleep hygiene, and self-care practices for pregnant women with gestational diabetes mellitus and pregnancy-induced hypertension, provided in addition to routine antenatal care. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Fasting blood glucose concentration (mg/dL or mmol/L, according to site laboratory standard) will be measured at baseline and at follow-up. The outcome measure is the change from baseline to 40 weeks gestation, compared between study groups. | Baseline and 40 weeks gestation |
| Blood Pressure | Systolic and diastolic blood pressure (mmHg) measured at baseline and follow-up. Outcome is change from baseline to 36 weeks gestation compared between study groups. | Baseline and 36 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assia Riaz, PhD Public Health | Contact | +92 322 4071468 | assia.res.iscs@pu.edu.pk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41076518 | Background | Lin C, Guan Q, Su B, Lin H, Xu Y, Wu Q, Ge L. Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes. BMC Pregnancy Childbirth. 2025 Oct 11;25(1):1070. doi: 10.1186/s12884-025-07932-2. | |
| 39056646 | Background | Phudphad T, Teravecharoenchai S, Khemtong P, Suksatan W. Examining the Impact of a Behavior Modification Program on Disease Prevention Behaviors among Individuals at Risk of Diabetes: A Quasi-Experimental Investigation. Eur J Investig Health Psychol Educ. 2024 Jul 6;14(7):1969-1980. doi: 10.3390/ejihpe14070131. |
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De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be made available to researchers upon reasonable request. Shared data will include demographic, clinical (fasting blood glucose, systolic/diastolic blood pressure), maternal outcomes (e.g., preeclampsia, mode of delivery), neonatal outcomes (e.g., birth weight, gestational age), and knowledge/self-care practice scores. The study protocol, statistical analysis plan, and informed consent form will also be shared.
Data will become available starting 6 months after publication of the primary trial results and will remain available for 5 years.
Access will be granted to researchers who submit a methodologically sound proposal with a clear research question, approved by the principal investigator and the Punjab University Institutional Ethics Review Board. A signed data access agreement ensuring confidentiality and appropriate use is required.
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Two-arm parallel randomized controlled trial comparing BMW Toolkit + routine care versus routine antenatal care alone
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Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. Outcome assessors/data analysts may be blinded where feasible.
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| Routine Antenatal Care | Other | Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension. |
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| Sir Ganga Ram Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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| 40016820 | Background | Dang NT, Le HM, Nguyen A, Glode PC, Vinter CA, Nielsen J, Nguyen KD, Gammeltoft TM, Linde DS. Self-care interventions among women with gestational diabetes mellitus in low and middle-income countries: a scoping review. Syst Rev. 2025 Feb 27;14(1):50. doi: 10.1186/s13643-025-02790-7. |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D016640 | Diabetes, Gestational |
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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