[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meal-time\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meal-time":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":45,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100634052","early-pregnancy-lifestyle-and-glucose-patterns-a-substudy-of-tofffy-100634052",false,"NCT07534670","Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY","Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY","Inclusion Criteria:\n\n* Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)\n* Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment\n\nExclusion Criteria:\n\n* Females with pre-existing diabetes mellitus (Type 1 or Type 2) and\u002For chronic medical conditions affecting glucose metabolism\n* Females who are taking medications known to significantly affect glucose metabolism\n* Females with multiple pregnancy (e.g., twins or higher-order gestation)\n* Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device",true,"FEMALE","21 Years","39 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.\n\nThe main questions it aims to answer are:\n\n1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?\n2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?\n3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?\n\nThis study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).\n\nParticipants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Continuous Glucose Monitoring","Diabetes, Gestational","Diet During Pregnancy","Meal Time","Actigraphy","Pregnancy","Glucose Intolerance During Pregnancy","Gestational Diabetes Mellitus in Pregnancy","Circadian Rhythm","Sleep","Chronobiology","Wearable Electronic Devices","Mobile Applications","Blood Glucose Profile","Metabolic Diseases","Randomized Controlled Trial","Pilot Study",[46,47,48,49,50,51],"Risk factor","Lifestyle","Early pregnancy","Chrono-disruptive behaviours","Maternal health","Lifestyle intervention","NOT_YET_RECRUITING","2026-04-22",{"date":55,"type":56},"2026-04-27","ACTUAL",{"date":58,"type":22},"2026-05-01",{"date":60,"type":22},"2027-06-30",{"name":62,"class":63},"KK Women's and Children's Hospital","OTHER_GOV",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":16,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":64},"100617855","chrono-align-a-chronotype-based-chrono-nutrition-intervention-in-post-bariatric-patients-100617855","NCT07324044","Chrono-ALIGN: A Chronotype-Based Chrono-Nutrition Intervention in Post-Bariatric Patients","Chrono-ALIGN Trial: The Impact of Chronotype-Based Chrono-Nutrition on Metabolic Health, Gut Microbiota, Appetite, and Circadian Alignment in Post-Bariatric Surgery Patients: A Randomized Controlled Trial","Chrono-ALIGN","Inclusion Criteria:\n\n* Adults aged 18-50 years who underwent Sleeve Gastrectomy (SG) 6 Months prior to enrollment.\n* Have achieved ≥50% of excess weight loss post-surgery (to ensure initial success).\n* Current BMI between 25-40 kg\u002Fm².\n* No major postoperative complications and cleared for a regular diet by their healthcare provider.\n* Participants must be able to align their eating schedule within a daytime window (morning to evening), ensuring that the first meal is consumed in the early part of the day and the last meal is completed before late evening, in accordance with chrono-nutrition guidelines.\n\nExclusion Criteria:\n\n* • Pregnancy or planned pregnancy during the study period, and post menopaused females\n\n  * Current diagnosis of severe psychiatric illness that may interfere with adherence (e.g., untreated major depression, psychosis, severe eating disorders).\n  * Active malignancy or serious chronic disease unrelated to obesity that may confound outcomes (e.g., advanced renal failure, uncontrolled liver disease).\n  * Use of medications known to significantly alter circadian rhythm or metabolism (e.g., corticosteroids, melatonin therapy) within the last 3 months.\n  * Inability to comply with study requirements (dietary interventions, sample collection, or follow-up visits).Participants who have previously undergone revision bariatric surgery.\n  * Individuals following intermittent fasting regimens prior to the study.","ALL","18 Years","50 Years",{"count":77,"type":22},246,[25],"This randomized controlled trial will evaluate the impact of chrono-nutrition, a dietary approach that aligns meal timing with the body's circadian rhythms, on weight change, metabolic outcomes, appetite, and gut microbiota in post-bariatric surgery patients. A total of 246 adults who underwent sleeve gastrectomy at least six months earlier will be enrolled at King Saud Medical City. Participants will be randomized to receive either standard post-bariatric nutritional care or personalized chrono-nutrition based on individual chronotype. Outcomes include weight change, metabolic biomarkers, dietary behaviors, sleep patterns, and gut microbiota composition. The study aims to determine whether integrating chrono-nutrition into post-bariatric follow-up can enhance metabolic health and improve long-term health.",[81,82,83,31,84,36],"Obesity (Disorder)","Morbid Obesity","Bariatric Sleeve Gastrectomy","Chronotype",[86,87,88,89,90,91],"chrononutrition","Bariatric Surgery","Gastric Sleeve","Gut Microbiota","Appetite","Meal Timing","2025-12-23",{"date":94,"type":56},"2026-01-07",{"date":96,"type":22},"2026-01-01",{"date":98,"type":22},"2028-12-01",{"name":100,"class":101},"King Saud University","OTHER"]