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Recruiting Not applicable NCT07551011

Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial

No applicable phase (e.g. observational)
Conditions: Gestational Diabetes Mellitus in Pregnancy Hypertension ,Pregnancy

Sponsor: University of the Punjab

trial.available_in: БГ
Overview
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.
Description
Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) are major contributors to maternal and neonatal morbidity, particularly in low- and middle-income countries. Evidence suggests that lifestyle and self-care interventions focusing on diet, physical activity, and sleep may improve maternal outcomes; however, rigorously designed randomized controlled trials evaluating structured behavioral toolkits in Pakistan are scarce.
Who can participate
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.
Interventions
Behavioral Modification Working (BMW) Toolkit
BEHAVIORAL
Routine Antenatal Care
OTHER
Locations 2
Pakistan (2)
Shaikh Zayed Hospital
Lahore , Punjab Province
Sir Ganga Ram Hospital
Lahore , Punjab Province
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
15 Years
Maximum age
49 Years
Healthy volunteers
No
Start date
21.04.2026
Completion date
15.01.2027
Registry ID
NCT07551011
Source
clinicaltrials.gov
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