Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes.
Canying Lin, Qingzhen Guan, Bilan Su...
https://pubmed.ncbi.nlm.nih.gov/41076518Actively Recruiting
Phase Not Applicable
Age: 15Years - 49Years
FEMALE
ID07551011
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial
Led by University of the Punjab · Updated on 2026-04-30
220
Participants Needed
2
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a Behavioral Modification Working (BMW) Toolkit in improving blood sugar control and blood pressure among pregnant women diagnosed with both gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH). These conditions are significant contributors to health problems for mothers and babies, especially in low- and middle-income countries. The study addresses a gap by rigorously assessing a structured behavioral intervention within this population. Participants are assigned randomly to one of two groups. One group receives the BMW Toolkit alongside their usual antenatal care, which includes 7 to 8 structured sessions led by a trained health educator. These sessions focus on improving diet, promoting physical activity, enhancing sleep habits, and encouraging self-care practices during pregnancy. The other group receives standard antenatal care for managing GDM and PIH without the behavioral toolkit. Throughout the study, women will be monitored for key health indicators. Fasting blood glucose levels are measured at the start and again at 40 weeks of pregnancy, while blood pressure is checked at baseline and 36 weeks gestation. The study will track how participants respond to the interventions, with all care provided under medical supervision. The study is planned to run until January 2027, involving regular assessments to understand the impact of the behavioral program on maternal health.
CONDITIONS
Brief Title
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
Who Can Participate
Age: 15Years - 49Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 15 to 49 years
- Gestational age between 16 and 20 weeks at enrollment
- Diagnosed with both gestational diabetes mellitus and pregnancy-induced hypertension
- 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, such as twins or triplets
- Severe psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - From enrollment until delivery (approximately 20 to 24 weeks)
Participants receive 7-8 structured behavioral sessions delivered by a trained health educator focusing on diet, physical activity, sleep hygiene, and self-care practices during pregnancy, in addition to routine antenatal care.
7 to 8 visits for behavioral sessions plus routine antenatal visits
Trial Site Locations
Total: 2 locations
1
Shaikh Zayed Hospital
Lahore, Punjab Province, Pakistan, 54000
Actively Recruiting
2
Sir Ganga Ram Hospital
Lahore, Punjab Province, Pakistan, 54000
Actively Recruiting
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Research Team
A
Assia Riaz, PhD Public Health
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.
Thanatkorn Phudphad, Supat Teravecharoenchai, Panit Khemtong...
https://pubmed.ncbi.nlm.nih.gov/39056646Self-care interventions among women with gestational diabetes mellitus in low and middle-income countries: a scoping review.
Ngoc-Anh Thi Dang, Hieu Minh Le, Ai Nguyen...
https://pubmed.ncbi.nlm.nih.gov/40016820