Behavioral toolkit to help pregnant women manage gestational diabetes and pregnancy-related high blood pressure.
Official title: Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial
Run by University of the Punjab · NCT07551011 · Data updated 2026-11-12
This program will test whether a structured behavioral toolkit helps pregnant women with both gestational diabetes and pregnancy-induced high blood pressure better control their blood sugar and blood pressure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 49 Years |
| Sex | Women only |
| Enrollment | 220 (estimated) |
| Sponsor | University of the Punjab Academic / other |
| Locations | 2 sites (Lahore, Punjab Province and 1 other locations) |
| Status | Recruiting |
| Started | April 21, 2026 |
| Main results expected | December 25, 2026 |
| Study ends | January 15, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07551011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 15–49 years, 16–20 weeks' gestation, diagnosed with both GDM and PIH, and who have had at least one antenatal visit at the study site.
✕Probably not a fit
Women with pre-existing diabetes or chronic hypertension, major medical conditions (renal, thyroid, hematologic), multiple pregnancy, or severe psychiatric illness are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant women between 16 and 20 weeks who have both gestational diabetes mellitus and pregnancy-induced hypertension will be enrolled at two Lahore hospitals and receive either the Behavioral Modification Working (BMW) Toolkit plus routine antenatal care or routine antenatal care alone. The toolkit delivers structured guidance on diet, physical activity, sleep, and self-monitoring of glucose and blood pressure alongside routine antenatal visits. Primary outcomes are changes in glycemic control and blood pressure during pregnancy, with secondary outcomes including maternal and neonatal complications through delivery. The trial is conducted at public tertiary hospitals in Pakistan to test a scalable behavioral approach in a low- and middle-income country setting.
Why it matters
Potential benefit: If successful, the toolkit could help pregnant women keep blood sugar and blood pressure better controlled and reduce risks for mothers and newborns.
How similar studies have gone: Lifestyle and self-care interventions have shown benefits for glucose and blood pressure control in some settings, but rigorously designed trials of structured behavioral toolkits for GDM and PIH in Pakistan are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Shaikh Zayed Hospital
Lahore, Punjab Province, Pakistan Recruiting -
Sir Ganga Ram Hospital
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Study coordinator: Assia Riaz, PhD Public Health
- Email: assia.res.iscs@pu.edu.pk
- Phone: +92 322 4071468
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.