[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100272703":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":79,"studyPopulation":80,"armGroups":75,"interventions":75,"overallOfficials":81,"centralContacts":85,"locations":94,"responsibleParty":111,"collaborators":75,"id":114,"slug":75,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":75,"enrollmentInfo":124,"targetDuration":75,"studyType":127,"phases":75,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":97,"whyStopped":75,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Universidad de Murcia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":75},[9,13],{"measure":10,"description":11,"timeFrame":12},"Total weight loss","Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg, at the same time each day.","weekly, during the 28 weeks of treatment",{"measure":14,"description":15,"timeFrame":16},"Long term weight loss maintenance","Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg.","once at least one year after ending the treatment",[18,22,25,28,31,34,37,40,43,46,49,52,55,59,63,66,69,72],{"measure":19,"description":20,"timeFrame":21},"Food timing","Timing of breakfast, lunch and dinner","at baseline",{"measure":23,"description":24,"timeFrame":21},"Sleep timing","Habitual sleep timing is estimated using a self-reported questionnaire.",{"measure":26,"description":27,"timeFrame":21},"Siesta timing questionnaire","Habitual siesta timing is estimated using a self-reported questionnaire.",{"measure":29,"description":30,"timeFrame":21},"Individual chronotype questionnaire","With the Morning and Eveningness Questionnaire (MEQ)",{"measure":32,"description":33,"timeFrame":21},"Food habits questionnaire","Variety of food groups is assessed by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. The number of different food items per day will be counted to assess variety of food",{"measure":35,"description":36,"timeFrame":21},"Total energy intake dietary questionnaire","by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. Daily energy intake will be calculated",{"measure":38,"description":39,"timeFrame":21},"Macronutrient distribution dietary questionnaire","by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. Macronutrient (% from total calories of the diet) and (grams) will be calculated",{"measure":41,"description":42,"timeFrame":21},"Glycemic Index questionnaire","by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. The glycemic index will be calculated by using different composition tables",{"measure":44,"description":45,"timeFrame":21},"Barriers to Weight Loss checklist","A questionnaire will be complete by the participants. The test consisted of 29 questions classified into seven sections: meal recording; weight control and weekly interviews; eating habits; portion size; food and drink choice; way of eating; and other obstacles to weight loss. There are were three possible responses (never 0, sometimes 1, very often 2) to those questions that represented barriers to losing weight, such as ''Have you lost your motivation?'' or ''Do you have binges?'' Questions that represented aids to weight loss, such as ''Do you accurately measure your portions?'' or ''Is absolutely everything written down?'' applied the same score (0 to 2) but with negative signs. A final ''Barriers to Weight Loss'' score is calculated by adding every answer's score for each patient.",{"measure":47,"description":48,"timeFrame":21},"Emotional eating questionnaire","The EEQ (Emotional eating Questionnaire) will be used extent emotions affect eating behaviour. . All the questions had four possible replies: 1) Never, 2) Sometimes; 3) Generally and 4) Always. Each reply was given a score of 1 to 4, the lower the score, the healthier the behaviour. For the clinical practice subjects are classified in four groups attending to the score obtained. Score between 0-5: non-emotional eater. Score between 6-10: low emotional eater. Score between 11-20: emotional eater. Score between 21-30: very emotional eater.",{"measure":50,"description":51,"timeFrame":21},"Physical activity questionnaire","by the IPAQ (international Physical Activity Questionnaire)",{"measure":53,"description":54,"timeFrame":21},"Mediterranean Diet Score questionnaire","By the questionnaire developed by Antonia Trichopoulou, M.D., Tina Costacou, Ph.D., Christina Bamia, Ph.D., and Dimitrios Trichopoulos, M.D.\n\nN Engl J Med 2003; 348:2599-2608June 26, 2003DOI: 10.1056\u002FNEJMoa025039",{"measure":56,"description":57,"timeFrame":58},"Glucose tolerance","either by meal test or by glucose tolerance test","from 1 year to 3 years after weight loss treatment",{"measure":60,"description":61,"timeFrame":62},"Daily rhythms of wrist temperature","7 day-record of wrist temperature by wrist temperature sensors.","from 3 months to 3 years after weight loss treatment",{"measure":64,"description":65,"timeFrame":62},"Daily rhythms of activity","7 day-record of activity by actiwatch",{"measure":67,"description":68,"timeFrame":62},"Daily rhythms of autonomus system by ambulatory electrocardiography","7 days of ambulatory electrocardiography",{"measure":70,"description":71,"timeFrame":21},"Glucose","Fasting glucose",{"measure":73,"description":74,"timeFrame":21},"Insulin","Fasting insulin",null,{"allocation":75,"interventionModel":75,"interventionModelDescription":75,"primaryPurpose":75,"observationalModel":77,"timePerspective":78,"maskingInfo":75},"COHORT","PROSPECTIVE","Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only \"what\" but also \"when\" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. Furthermore, it has been shown that eating late at night when plasma melatonin concentrations are elevated, impairs glucose tolerance, particularly in MTNR1B risk allele carriers.\n\nThe main objective is to identify the mechanisms underlying the association between the timing of food intake, obesity and metabolic syndrome (MetS) in order to design effective weight loss therapies. The long-term goal is to determine the potential impact of more European, i.e., earlier meal timing on obesity, MetS and weight loss.\n\nThe challenge for the society is to develop evidence-based dietary interventions incorporating meal timing and genotype to combat the epidemic of obesity and MetS.\n\nThese goals will be achieved through three specific approaches:\n\n* Epidemiological (observational study) (Aim 1): To assess in an obese population (n=5000) who will follow a weight loss program if clock-related (CLOCK, PER2, CRY, etc.) and melatonin-related variants (MTNR1B) interact with the timing of food intake to determine weight loss effectiveness and MetS features.\n* Interventional (randomized controlled trials) (Aim 2): To determine the internal mechanisms of energy balance and circadian system implicated in the differential effects of food timing (lunch) on weight loss, MetS alterations and the intestinal microbiota (n=25), and to study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance in obese women (n=100).\n\nProspective Follow-up (Long-term Assessment):\n\nWe will recontact all individuals who previously participated in the ONTIME study and completed a weight-loss program at nutritional clinics at least four years ago (n=5603), aiming to achieve a final sample of approximately 500 participants. Participants will attend the nutritional clinic, where body weight, height, waist and hip circumference, and total body fat will be assessed using standardized methods. Blood samples will be collected for biochemical and genetic analyses. On the first day, participants will complete questionnaires on medical history, emotional eating, environmental factors, chronotype, sleep, physical activity, and dietary intake. All variables measured are the same as those assessed at the start of the study. Additionally, for seven consecutive days, participants will record their food intake, physical activity, and sleep using a mobile application. From this population, a subpopulation of 200 participants will undergo ambulatory ECG for three days and seven-day actigraphy and temperature monitoring using Kronosensor and a light pendant. This follow-up will allow the assessment of long-term weight loss maintenance, behavioral timing, and physiological markers several years after the initial intervention.","All participants are voluntarily attending five weight loss clinics in Spain for dietetic and behavioral treatment based upon the principles of a Mediterranean diet . All participants are from the Spanish city of Murcia, located on the Southeast coast of the Mediterranean Sea.",[82],{"name":83,"affiliation":5,"role":84},"Marta Garaulet, PHD","PRINCIPAL_INVESTIGATOR",[86,90],{"name":83,"role":87,"phone":88,"phoneExt":75,"email":89},"CONTACT","+34-678996368","garaulet@um.es",{"name":91,"role":87,"phone":92,"phoneExt":75,"email":93},"Purificacion Gomez-Abellan, PHD","+34-968221990","puriki4@hotmail.com",[95],{"facility":96,"status":97,"city":98,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"University of Murcia","RECRUITING","Murcia","30100","Spain","ES",{"type":103,"coordinates":104},"Point",[105,106],-1.13004,37.98704,{"lat":106,"lon":105},[109],{"name":83,"role":87,"phone":110,"phoneExt":75,"email":89},"+34678996368",{"type":84,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":75,"oldOrganization":75},"PROF. MARTA GARAULET AZA","Full Professor","100272703",false,"NCT02829619","Meal Timing, Genetics and Weight Loss","Meal Timing, Genetics and Weight Loss in a Mediterranean Population","ONTIME","Inclusion Criteria:\n\n* Body Mass Index: \\>25 kg\u002Fm2\n* Age: \\>18 years of age\n* Caucasian\n\nExclusion Criteria:\n\n* Receiving treatment with thermogenic, lipogenic, or contraceptive drugs\n* Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis\n* bulimia diagnosis, prone to binge eating\n* undergoing treatment with anxiolytic or antidepressant drugs",true,"ALL","18 Years",{"count":125,"type":126},5788,"ESTIMATED","OBSERVATIONAL","Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only \"what\" but also \"when\" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims to study in a Mediterranean population the potential influence of genetics and food timing on obesity, metabolic syndrome and weight loss.",[130],"Obesity",[130,132,133,134],"Nutrigenetics","Food Timing","Weight loss","2026-04-29",{"date":137,"type":138},"2026-05-06","ACTUAL",{"date":140,"type":138},"2008-01-01",{"date":142,"type":126},"2032-06",{"name":5,"class":6},1]