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NCT Number: NCT07551011

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Behavior Behavior, Animal Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hypertension ,Pregnancy Hypertension, Pregnancy-Induced Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Hospital, Lahore, Punjab Province, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BMW Toolkit

Routine Antenatal Care

Other

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

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: 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.

  2. Blood Pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Assia Riaz, PhD Public Health

CONTACT

[email protected]

+92 322 4071468

Dr Muhammad Navid Tahir, Public Health

CONTACT

[email protected]

+92 333 4245831

Sponsors and collaborators

Lead sponsor

University of the Punjab

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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