Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
1 other identifier
interventional
220
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2026
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 15, 2027
April 30, 2026
April 1, 2026
8 months
April 19, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
BMW Toolkit + Routine Antenatal Care
EXPERIMENTALParticipants 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.
Routine Antenatal Care Alone
ACTIVE COMPARATORParticipants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention.
Interventions
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.
Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
Eligibility Criteria
You may qualify if:
- Pregnant women aged 15-49 years.
- Gestational age between 16 and 20 weeks at enrolment.
- Diagnosed with both gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH).
- At least one prior antenatal visit at the study site.
You may not qualify if:
- Pre-existing diabetes mellitus or chronic hypertension prior to pregnancy.
- Pre-existing renal disease, thyroid disease, or major hematological disorders.
- Multiple pregnancy (e.g., twins, triplets).
- Severe psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shaikh Zayed Hospital
Lahore, Punjab Province, 54000, Pakistan
Sir Ganga Ram Hospital
Lahore, Punjab Province, 54000, Pakistan
Related Publications (3)
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.
PMID: 41076518BACKGROUNDPhudphad 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.
PMID: 39056646BACKGROUNDDang 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.
PMID: 40016820BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. Outcome assessors/data analysts may be blinded where feasible.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 19, 2026
First Posted
April 24, 2026
Study Start
April 21, 2026
Primary Completion (Estimated)
December 25, 2026
Study Completion (Estimated)
January 15, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will become available starting 6 months after publication of the primary trial results and will remain available for 5 years.
- Access Criteria
- 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.
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.