Gestational Diabetes Mellitus in Pregnancy, Hypertension ,Pregnancy
Conditions
Keywords
Gestational Diabetes Mellitus, Pregnancy Induced Hypertension, Maternal health, Childbirth, Risk Factors, intervention, BMW Toolkit, Dietary habits, Physical activity, sleep pattern
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALBehavioral 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.
Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
Sponsors
University of the Punjab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. Outcome assessors/data analysts may be blinded where feasible.
Intervention model description
Two-arm parallel randomized controlled trial comparing BMW Toolkit + routine care versus routine antenatal care alone
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | Baseline and 40 weeks gestation | Fasting blood glucose concentration (mg/dL or mmol/L, according to site laboratory standard) will be measured at baseline and at follow-up. The outcome measure is the change from baseline to 40 weeks gestation, compared between study groups. |
| Blood Pressure | Baseline and 36 weeks gestation | Systolic and diastolic blood pressure (mmHg) measured at baseline and follow-up. Outcome is change from baseline to 36 weeks gestation compared between study groups. |
Countries
Pakistan
Contacts
CONTACTAssia Riaz, PhD Public Health
CONTACTDr Muhammad Navid Tahir, Public Health
Outcome results
None listed