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

April 24, 2026 updated by: Assia Riaz, University of the Punjab

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
      • Lahore, Punjab Province, Pakistan, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMW Toolkit + Routine Antenatal Care
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.
Behavioral: Behavioral 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.
Other Names:
  • BMW Toolkit
Active Comparator: Routine Antenatal Care Alone
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.
Other: Routine Antenatal Care
Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 40 weeks gestation
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.
Baseline and 36 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Punjab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD-PH-E-F23-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be made available to researchers upon reasonable request. Shared data will include demographic, clinical (fasting blood glucose, systolic/diastolic blood pressure), maternal outcomes (e.g., preeclampsia, mode of delivery), neonatal outcomes (e.g., birth weight, gestational age), and knowledge/self-care practice scores. The study protocol, statistical analysis plan, and informed consent form will also be shared.

IPD Sharing Time Frame

Data will become available starting 6 months after publication of the primary trial results and will remain available for 5 years.

IPD Sharing Access Criteria

Access will be granted to researchers who submit a methodologically sound proposal with a clear research question, approved by the principal investigator and the Punjab University Institutional Ethics Review Board. A signed data access agreement ensuring confidentiality and appropriate use is required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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