About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Behavioral Modification Working (BMW) Toolkit
BehavioralStructured 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.
Routine Antenatal Care
Other interventionStandard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
Treatment groups
Trial outcomes
Primary outcomes
Fasting Blood Glucose
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
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.
Sponsors and contacts
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