Recruiting
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
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.
ClinicalTrials.gov IDNCT07551011
PhaseNA
Enrollment220
SponsorUniversity of the Punjab
Age15 Years
SexFEMALE
Conditions studied
Gestational Diabetes Mellitus in Pregnancy, Hypertension ,Pregnancy
About this study
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.
Interventions
- Behavioral: Behavioral Modification Working (BMW) Toolkit — 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.
- Other: Routine Antenatal Care — Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
Primary outcomes
- Fasting Blood Glucose (Baseline and 40 weeks gestation)
- Blood Pressure (Baseline and 36 weeks gestation)
Eligibility information
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.
Study locations
- Shaikh Zayed Hospital, Lahore, Punjab Province 54000 Pakistan
- Sir Ganga Ram Hospital, Lahore, Punjab Province 54000 Pakistan
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.