Evaluating a Behavioral Toolkit to Improve Blood Sugar and Blood Pressure in Pregnant Women With Gestational Diabetes and Hypertension
Led by University of the Punjab · Updated on 2026-07-13
220
Participants Needed
2
Research Sites
3 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate how a Behavioral Modification Working BMW Toolkit can improve blood sugar control and blood pressure in pregnant women diagnosed with both gestational diabetes mellitus GDM and pregnancy-induced hypertension PIH. These conditions contribute significantly to health risks for mothers and newborns, especially in low- and middle-income countries. The trial focuses on structured behavioral interventions to support lifestyle changes during pregnancy, addressing a gap in rigorously designed studies in Pakistan.
Participants in this randomized controlled trial are divided into two groups. One group receives the BMW Toolkit alongside routine antenatal care, which includes 7-8 structured sessions led by a trained health educator. These sessions cover dietary changes, physical activity, sleep hygiene, and self-care during pregnancy. The other group receives only the standard antenatal care typically provided for managing GDM and PIH without the toolkit.
During the study, participants will be assessed for fasting blood glucose levels at the start and at 40 weeks of pregnancy, and blood pressure readings at the start and at 36 weeks. The trial monitors these key health measures to understand the impact of the behavioral toolkit. Participation involves regular antenatal visits and adherence to the intervention sessions, with ongoing evaluation to support maternal health outcomes until delivery.
CONDITIONS
Brief Title
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
Research Team
A
Assia Riaz, PhD Public Health
D
Dr Muhammad Navid Tahir, Public Health
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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 will not qualify if you...
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.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From enrolment until delivery
Participants receive either the Behavioral Modification Working Toolkit along with routine antenatal care or routine antenatal care alone. The toolkit includes 7-8 sessions focusing on diet, physical activity, sleep, and self-care during pregnancy.
7-8 sessions with a health educator plus regular antenatal visits
Follow-up
Duration - Until 40 weeks of gestation
Participants are monitored through fasting blood glucose and blood pressure measurements at specified pregnancy weeks to assess health outcomes.
Assessments at baseline, 36 weeks, and 40 weeks gestation
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Examining the Impact of a Behavior Modification Program on Disease Prevention Behaviors among Individuals at Risk of Diabetes: A Quasi-Experimental Investigation.
Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes.