RecruitingNot ApplicableNCT07551011

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

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


Sponsor

University of the Punjab

Enrollment

220 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 49 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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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.

OTHERRoutine Antenatal Care

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


Locations(2)

Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Sir Ganga Ram Hospital

Lahore, Punjab Province, Pakistan

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NCT07551011


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