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

University of the Punjab

Status: Enrolling

Conditions: Gestational Diabetes Mellitus in Pregnancy; Hypertension ,Pregnancy

Treatments: Other: Routine Antenatal Care; Behavioral: Behavioral Modification Working (BMW) Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT07551011

PhD-PH-E-F23-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

BMW Toolkit + Routine Antenatal Care

Experimental group

Description:

Participants receive the Behavioral Modification Working (BMW) Toolkit in addition to routine antenatal care. The intervention includes 7-8 structured sessions delivered by a trained health educator focusing on dietary modification, physical activity, sleep hygiene, and self-care practices during pregnancy.

Treatment:

Behavioral: Behavioral Modification Working (BMW) Toolkit

Routine Antenatal Care Alone

Active Comparator group

Description:

Participants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention.

Treatment:

Other: Routine Antenatal Care