Gestational Diabetes Mellitus in PregnancyNCT07551011
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
A study testing Behavioral Modification Working (BMW) Toolkit and Routine Antenatal Care in people with Gestational Diabetes Mellitus in Pregnancy and Hypertension ,Pregnancy, run by University of the Punjab at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Hypertension ,Pregnancy
- What is being tested?
- Behavioral Modification Working (BMW) Toolkit and Routine Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesPakistan
- Study dates
- 21 Apr 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Shaikh Zayed Hospital
Lahore, Punjab Province, 54000
Rameesa Liaqat, 03349716254, rameesaliaqat1998@gmail.com
- Recruiting
Sir Ganga Ram Hospital
Lahore, Punjab Province, 54000
Rameesa Liaqat, 03349716254, rameesaliaqat1998@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Behavioral Modification Working (BMW) Toolkit, Routine Antenatal Care
- Keywords
- Gestational Diabetes Mellitus, Pregnancy Induced Hypertension, Maternal health, Childbirth, Risk Factors, intervention, BMW Toolkit, Dietary habits, Physical activity, sleep pattern
- Medical subject headings
- Hypertension, Pregnancy-Induced, Diabetes, Gestational, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Modification Working (BMW) ToolkitBehavioural
Also called 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.
Routine Antenatal CareOther
Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
| Study group | Role | What they receive |
|---|---|---|
| BMW Toolkit + Routine Antenatal Care | Experimental | 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. Receives: Behavioral: Behavioral Modification Working (BMW) Toolkit |
| Routine Antenatal Care Alone | Active comparator | 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. Receives: Other: Routine Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 40 weeks gestation
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.
Measured: Baseline and 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start21 Apr 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized controlled trial comparing BMW Toolkit + routine care versus routine antenatal care alone
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assia Riaz, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551011
- Sponsor's protocol ID
- PhD-PH-E-F23-08
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lin C, Guan Q, Su B, Lin H, Xu Y, Wu Q, Ge L. Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes. BMC Pregnancy Childbirth. 2025 Oct 11;25(1):1070. doi: 10.1186/s12884-025-07932-2.
PubMed 41076518Phudphad T, Teravecharoenchai S, Khemtong P, Suksatan W. Examining the Impact of a Behavior Modification Program on Disease Prevention Behaviors among Individuals at Risk of Diabetes: A Quasi-Experimental Investigation. Eur J Investig Health Psychol Educ. 2024 Jul 6;14(7):1969-1980. doi: 10.3390/ejihpe14070131.
PubMed 39056646Dang NT, Le HM, Nguyen A, Glode PC, Vinter CA, Nielsen J, Nguyen KD, Gammeltoft TM, Linde DS. Self-care interventions among women with gestational diabetes mellitus in low and middle-income countries: a scoping review. Syst Rev. 2025 Feb 27;14(1):50. doi: 10.1186/s13643-025-02790-7.
PubMed 40016820
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07551011
- Acronym / sponsor ID
- PhD-PH-E-F23-08
- Keywords
- Gestational Diabetes Mellitus, Pregnancy Induced Hypertension, Maternal health, Childbirth, Risk Factors, intervention, BMW Toolkit, Dietary habits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial comparing BMW Toolkit + routine care versus routine antenatal care alone
| Arm | Type | Receives |
|---|---|---|
| BMW Toolkit + Routine Antenatal Care | Experimental | Behavioral: Behavioral Modification Working (BMW) ToolkitParticipants 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. |
| Routine Antenatal Care Alone | Active comparator | Other: Routine Antenatal CareParticipants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Modification Working (BMW) ToolkitAlso: BMW ToolkitStructured 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. | Behavioural | BMW Toolkit + Routine Antenatal Care |
| Routine Antenatal CareStandard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension. | Other | Routine Antenatal Care Alone |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 41076518Lin C, Guan Q, Su B, Lin H, Xu Y, Wu Q, Ge L. Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes. BMC Pregnancy Childbirth. 2025 Oct 11;25(1):1070. doi: 10.1186/s12884-025-07932-2.
- Background: PubMed 39056646Phudphad T, Teravecharoenchai S, Khemtong P, Suksatan W. Examining the Impact of a Behavior Modification Program on Disease Prevention Behaviors among Individuals at Risk of Diabetes: A Quasi-Experimental Investigation. Eur J Investig Health Psychol Educ. 2024 Jul 6;14(7):1969-1980. doi: 10.3390/ejihpe14070131.
- Background: PubMed 40016820Dang NT, Le HM, Nguyen A, Glode PC, Vinter CA, Nielsen J, Nguyen KD, Gammeltoft TM, Linde DS. Self-care interventions among women with gestational diabetes mellitus in low and middle-income countries: a scoping review. Syst Rev. 2025 Feb 27;14(1):50. doi: 10.1186/s13643-025-02790-7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Modification Working (BMW) Toolkit and Routine Antenatal Care in people with Gestational Diabetes Mellitus in Pregnancy and Hypertension ,Pregnancy, run by University of the Punjab at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assia Riaz, PhD Public Health (+92 322 4071468, assia.res.iscs@pu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: Baseline and 40 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551011, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.