Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-49
SponsorUniversity of the Punjab

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioral Modification Working (BMW) Toolkit

    Behavioral

    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.

  • Routine Antenatal Care

    Other intervention

    Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: BMW Toolkit + Routine Antenatal CareExperimental treatment 1 intervention
Group B: Routine Antenatal Care AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 40 weeks gestation
2

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.

Time frame
Baseline and 36 weeks gestation

Secondary outcomes

Other outcomes

Sponsors and contacts

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