[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630591":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":17,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":88,"whyStopped":17,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Aga Khan University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Indigenous Balanced Diet Arm","Participants in this arm will receive minimally modified culturally-tailored indigenous heat-mitigating balanced diet as once a day meal starting from at least one month before conception and throughout the pregnancy till delivery.",[12],"Dietary Supplement: Indigenous Balanced Diet Arm",{"label":14,"type":15,"description":16,"interventionNames":17},"Usual Diet Arm","NO_INTERVENTION","Pregnant women in this arm will continue with their usual diet, and receives standard antenatal care.",null,[19],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":17},"DIETARY_SUPPLEMENT","The uniqueness of this intervention lies in its culturally-preservative approach, its novel target of heat stress, its timing (preconception), and its integrated process (nutritionist collaboration + overall dietary counseling). It specifically targets heat resilience in pregnancy through a holistic approach of adapting dietary intervention as mitigating strategy for providing resilience to heat stress and evaluating key hypothesized pathways responsible for combating adverse pregnancy outcomes by this intervention.",[9],[24],{"name":25,"affiliation":5,"role":26},"Junaid Iqbal, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":17,"email":31},"CONTACT","+923353189185","junaid.iqbal@aku.edu",{"name":33,"role":29,"phone":34,"phoneExt":17,"email":35},"Kehkashan Begum Hussain, MS","+923368906517","kehkashan.begum@aku.edu",[37],{"facility":5,"status":17,"city":38,"state":17,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Karachi","74800","Pakistan","PK",{"type":43,"coordinates":44},"Point",[45,46],67.0104,24.8608,{"lat":46,"lon":45},[49,51],{"name":25,"role":29,"phone":50,"phoneExt":17,"email":31},"00922134861648",{"name":52,"role":29,"phone":53,"phoneExt":17,"email":35},"Kehkashan Begum, MS","00922134864088",{"type":26,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Junaid Iqbal","Assistant Professor (Research), Department of Paediatrics & Child Health.",[58],{"name":59,"class":6},"Bill and Melinda Gates Foundation","100630591","indigenous-nutritional-supplements-for-pregnancy-to-improve-resilience-in-environmental-heat-100630591",false,"NCT07489664","Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat","INSPIRE","Inclusion Criteria:\n\n1. Women aged 18-45 years belonging to a low to middle socioeconomic status, residing in Mithi, Districts in Sindh.\n2. Planning to conceive within the study time frame and expect to become pregnant within four months of starting nutritional intervention.\n3. Women who confirm their pregnancy during the first trimester i.e., before 8 weeks of gestational age.\n\nExclusion Criteria:\n\n1. Women using long-lasting contraceptives such as IUDs, implants, and injectable methods like Depo-Provera.\n2. Women with a history of multiple miscarriage or stillbirths.\n3. Women with known chronic diseases, such as cardiovascular disorders, hepatic disorders, renal disorders, and infectious diseases.\n4. Women suffering from severe malnutrition (WHO: Underweight i.e., having BMI \\\u003C 16 Kg\u002Fm2 or obese having BMI ≥ 30 Kg\u002Fm2).\n5. Women having severe anemia (WHO: Severe anemia i.e., Hb \\\u003C 7g\u002FdL).\n6. Women currently enrolled in BISP supplementation programs or taking any supplements other than iron and folic acid (IFA) will be excluded from the study.\n7. Those who do not become pregnant within three months of supplementation during pre-conception.",true,"FEMALE","18 Years","45 Years",{"count":72,"type":73},292,"ESTIMATED","INTERVENTIONAL",[76],"NA","The purpose of this study is to learn whether a simple, traditional, and balanced meal made from local foods, eaten once a day during pregnancy, can help women in rural Pakistan stay healthier in hot weather and give birth to healthier babies. Climate change has made heat a serious challenge for pregnant women, especially in areas with limited resources. This study will explore whether an indigenous meal that is culturally acceptable and easy to prepare can improve resilience to heat stress and support better outcomes for both mothers and newborns.\n\nThe study will focus on two main questions:\n\n* Can this daily balanced meal reduce the harmful effects of heat stress during pregnancy?\n* Does it improve newborn health, especially birth weight?\n\nResearchers will compare women who eat the balanced local meal every day with women who continue their usual meals. They will check changes in women's health, levels of key vitamins and nutrients, and their babies' birth outcomes.\n\nDuring the study, participants will:\n\n* Either eat the balanced local meal daily or continue their usual meals.\n* Share information on their health, diet, and heat exposure.\n* Provide small samples, such as blood and stool, to study nutrient levels and gut health.\n* Have their newborns' health and growth measured at birth.",[79,80,81,82],"Heat Stress","Pregnancy","Women of Reproductive Age","Nutrition Status",[84,85,86,87],"Local Food-Based Diet to Improve Birth Outcomes and Heat Resilience in Pregnant Women","maternal depression","placental transcriptomics","microbiome","NOT_YET_RECRUITING","2026-03-19",{"date":91,"type":92},"2026-03-24","ACTUAL",{"date":94,"type":73},"2026-03",{"date":96,"type":73},"2028-12",{"name":5,"class":6},1]