[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053733":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":40,"overallOfficials":17,"centralContacts":52,"locations":62,"responsibleParty":89,"collaborators":17,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":17,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":17,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":65,"whyStopped":17,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of the Punjab","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Fasting Blood Glucose","Fasting blood glucose concentration (mg\u002FdL or mmol\u002FL, 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",{"measure":14,"description":15,"timeFrame":16},"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.","Baseline and 36 weeks gestation",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Two-arm parallel randomized controlled trial comparing BMW Toolkit + routine care versus routine antenatal care alone","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. Outcome assessors\u002Fdata analysts may be blinded where feasible.","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.",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"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.",[33],"Behavioral: Behavioral Modification Working (BMW) Toolkit",{"label":35,"type":36,"description":37,"interventionNames":38},"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.",[39],"Other: Routine Antenatal Care",[41,48],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"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.",[29],[47],"BMW Toolkit",{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":17},"Routine Antenatal Care","Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.",[35],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":17,"email":57},"Assia Riaz, PhD Public Health","CONTACT","+92 322 4071468","assia.res.iscs@pu.edu.pk",{"name":59,"role":55,"phone":60,"phoneExt":17,"email":61},"Dr Muhammad Navid Tahir, Public Health","+92 333 4245831","navid.iscs@pu.edu.pk",[63,82],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Shaikh Zayed Hospital","RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":72,"coordinates":73},"Point",[74,75],74.35071,31.558,{"lat":75,"lon":74},[78],{"name":79,"role":55,"phone":80,"phoneExt":17,"email":81},"Rameesa Liaqat","03349716254","rameesaliaqat1998@gmail.com",{"facility":83,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Sir Ganga Ram Hospital",{"type":72,"coordinates":85},[74,75],{"lat":75,"lon":74},[88],{"name":79,"role":55,"phone":80,"phoneExt":17,"email":81},{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Assia Riaz","Principal Investigator","100053733","impact-of-behavioural-modification-working-toolkit-among-women-with-gestational-diabetes-mellitus-and-hypertension-100053733",false,"NCT07551011","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","Inclusion Criteria:\n\n* Pregnant women aged 15-49 years.\n* Gestational age between 16 and 20 weeks at enrolment.\n* Diagnosed with both gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH).\n* At least one prior antenatal visit at the study site.\n\nExclusion Criteria:\n\n* Pre-existing diabetes mellitus or chronic hypertension prior to pregnancy.\n* Pre-existing renal disease, thyroid disease, or major hematological disorders.\n* Multiple pregnancy (e.g., twins, triplets).\n* Severe psychiatric illness.","FEMALE","15 Years","49 Years",{"count":104,"type":105},220,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.",[111,112],"Gestational Diabetes Mellitus in Pregnancy","Hypertension ,Pregnancy",[114,115,116,117,118,119,47,120,121,122],"Gestational Diabetes Mellitus","Pregnancy Induced Hypertension","Maternal health","Childbirth","Risk Factors","intervention","Dietary habits","Physical activity","sleep pattern","2026-07-09",{"date":125,"type":126},"2026-07-13","ACTUAL",{"date":128,"type":126},"2026-04-21",{"date":130,"type":105},"2027-01-15",{"name":5,"class":6},2]