Behavioral toolkit to help pregnant women manage gestational diabetes and pregnancy-related high blood pressure.
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | University of the Punjab Academic / other |
| Locations | 2 sites (Lahore, Punjab Province and 1 other locations) |
| Trial ID | NCT07551011 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lahore, Punjab Province and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.