[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595754":3},{"organization":4,"outcomesModule":7,"designInfo":91,"detailedDescription":94,"studyPopulation":94,"armGroups":98,"interventions":109,"overallOfficials":94,"centralContacts":114,"locations":124,"responsibleParty":147,"collaborators":94,"id":149,"slug":94,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":94,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":127,"whyStopped":94,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Norwegian University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":70},[9],{"measure":10,"description":11,"timeFrame":12},"Total fat mass","Change in total fat mass measured with bioelectrical impedance analysis","From baseline to after 12 months",[14,18,20,23,26,29,32,35,38,41,44,47,49,52,55,57,60,63,67],{"measure":15,"description":16,"timeFrame":17},"Blood glucose","Fasting concentration of plasma glucose","From baseline to after 6 months and after 12 months",{"measure":10,"description":11,"timeFrame":19},"From baseline to after 6 months",{"measure":21,"description":22,"timeFrame":17},"Insulin","Fasting concentration of plasma insulin C-peptide",{"measure":24,"description":25,"timeFrame":17},"Average glucose levels","Glycated haemoglobin (HbA1c)",{"measure":27,"description":28,"timeFrame":17},"Blood cholesterol","Total fasting cholesterol in blood",{"measure":30,"description":31,"timeFrame":17},"LDL-cholesterol","Fasting low-density lipoprotein-cholesterol in blood",{"measure":33,"description":34,"timeFrame":17},"HDL-cholesterol","Fasting high-density lipoprotein-cholesterol in blood",{"measure":36,"description":37,"timeFrame":17},"Triglycerides","Fasting triglycerides in blood",{"measure":39,"description":40,"timeFrame":17},"Cardiorespiratory fitness","Peak oxygen uptake at a maximum effort test, measured in mL\u002Fmin\u002Fkg and L\u002Fmin",{"measure":42,"description":43,"timeFrame":17},"Insulin sensitivity","Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol\u002FL) x fasting plasma insulin C-peptide (pmol\u002FL)\u002F2800",{"measure":45,"description":46,"timeFrame":17},"Body mass","In kg, estimated with bioelectrical impedance analysis",{"measure":48,"description":46,"timeFrame":17},"Fat-free mass",{"measure":50,"description":51,"timeFrame":17},"Visceral fat area","In cm2, estimated with bioelectrical impedance analysis",{"measure":53,"description":54,"timeFrame":17},"Systolic blood pressure","Average of three measurements during rest in seated position, in mmHg",{"measure":56,"description":54,"timeFrame":17},"Diastolic blood pressure",{"measure":58,"description":59,"timeFrame":17},"Resting heart rate","Average of three measurements during rest in sitting position, in beats\u002Fmin",{"measure":61,"description":62,"timeFrame":17},"Physical activity levels","International Physical Activity Questionnaire",{"measure":64,"description":65,"timeFrame":66},"Diet intake","3-day diet diaries (two weekdays and one weekend day) with online diet diary.","During baseline week, after 4, 13, 30, and 50 weeks.",{"measure":68,"description":69,"timeFrame":17},"Sleep quality","The Pittsburgh Sleep Quality Index questionnaire",[71,75,78,81,84,88],{"measure":72,"description":73,"timeFrame":74},"Adherence to high-intensity interval training","Number of completed exercise sessions out of those prescribed, in percentage","12 months",{"measure":76,"description":77,"timeFrame":74},"Compliance to high-intensity interval training","Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.",{"measure":79,"description":80,"timeFrame":66},"Adherence to time-restricted eating","Average number of days per week a daily eating window of 10 hours or less was achieved",{"measure":82,"description":83,"timeFrame":66},"Compliance to time-restricted eating","Average daily eating window, self-reported in hours\u002Fday",{"measure":85,"description":86,"timeFrame":87},"Perception of intervention and digital follow-up","Qualitative interviews with selected participants to explore barriers and motivators","After 12 months",{"measure":89,"description":90,"timeFrame":17},"Sex differences","Sub-analyses of sex differences in the effectiveness of the intervention",{"allocation":92,"interventionModel":93,"interventionModelDescription":94,"primaryPurpose":95,"observationalModel":94,"timePerspective":94,"maskingInfo":96},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":97,"maskingDescription":94,"whoMasked":94},"NONE",[99,105],{"label":100,"type":101,"description":102,"interventionNames":103},"Time-restricted eating and high-intensity interval training","EXPERIMENTAL","12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up",[104],"Behavioral: Time-restricted eating and high-intensity interval training",{"label":106,"type":107,"description":108,"interventionNames":94},"Control","NO_INTERVENTION","No intervention or follow-up. Habitual lifestyle",[110],{"type":111,"name":100,"description":112,"armGroupLabels":113,"otherNames":94},"BEHAVIORAL","1-month intense periods of maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \\> 90 % heart rate maximum), separated by 3-month maintenance periods of time-restricted eating on 5 days per week and minimum 1 HIIT session per week. Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly during intense periods, and once monthly during maintenance periods. The intervention period will be 12 months in total.",[100],[115,120],{"name":116,"role":117,"phone":118,"phoneExt":94,"email":119},"Kamilla La Haganes, PhD","CONTACT","+4747316765","kamilla.l.haganes@ntnu.no",{"name":121,"role":117,"phone":122,"phoneExt":94,"email":123},"Trine Moholdt, PhD","+4797098594","trine.moholdt@ntnu.no",[125],{"facility":126,"status":127,"city":128,"state":94,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Department of circulation and medical imaging, NTNU","RECRUITING","Trondheim","7491","Norway","NO",{"type":133,"coordinates":134},"Point",[135,136],10.39506,63.43049,{"lat":136,"lon":135},[139,143,145],{"name":140,"role":117,"phone":141,"phoneExt":94,"email":142},"Beathe Sitter, PhD","+47 73412318","beathe.sitter@ntnu.no",{"name":116,"role":144,"phone":94,"phoneExt":94,"email":94},"SUB_INVESTIGATOR",{"name":121,"role":146,"phone":94,"phoneExt":94,"email":94},"PRINCIPAL_INVESTIGATOR",{"type":148,"investigatorFullName":94,"investigatorTitle":94,"investigatorAffiliation":94,"oldNameTitle":94,"oldOrganization":94},"SPONSOR","100595754",false,"NCT07036562","Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight\u002FObesity","Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health","TREHIIT-3","Inclusion Criteria:\n\n* Body mass index ≥ 27 kg\u002Fm²\n* Able to walk or ride a bike \\> 60 min\n\nExclusion Criteria:\n\n* On-going pregnancy\n* Lactation within 24 weeks of study commencement\n* High-intensity exercise ≥ 1\u002Fweek\n* Habitual eating window ≤12 hours\u002Fday\n* Taking hypertension, glucose-, or lipid-lowering drugs\n* Body mass variation ≥ 4 kg three months prior to study commencement\n* Known diabetes mellitus (type 1 or 2) or cardiovascular disease\n* Working night shifts","ALL","18 Years","50 Years",{"count":160,"type":161},100,"ESTIMATED","INTERVENTIONAL",[164],"NA","This study will investigate the effects of 12 months periodised time-restricted eating combined with high-intensity interval training compared with a control group on fat mass in adults with overweight\u002Fobesity. Participants in the intervention group will complete the intervention remotely and will receive follow-up by telephone. Before randomisation, after 6 months and after 12 months, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.",[167],"Overweight and Obesity",[169,170,171,172,173,174],"time-restricted eating","high-intensity interval training","exercise","diet","metabolic health","lifestyle intervention","2025-12-05",{"date":177,"type":178},"2025-12-12","ACTUAL",{"date":180,"type":178},"2025-09-11",{"date":182,"type":161},"2027-07",{"name":5,"class":6},1]