[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612568":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":35,"locations":36,"responsibleParty":89,"collaborators":35,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":39,"whyStopped":35,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Beira Interior","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Standard interventions focused on nutrition, physical activity\u002Fsedentary behavior, and other lifestyle aspects.",[13],"Other: Standard Obesity Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","EXPERIMENTAL","Standard intervention plus sleep-focused intervention. The sleep intervention will be conducted by psychologists. These monthly sessions, delivered in person or via video call, will be scheduled on the same day as the medical consultation whenever possible. The session planning and objectives are outlined in the study protocol.",[19,13],"Behavioral: Sleep Behavioral Intervention",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Sleep Behavioral Intervention","Our research team, composed by pediatricians with experience in Obesity and Adolescent Medicine, and clinical psychologists with experience in Sleep, Obesity, and Cognitive Behavioral Therapy (CBT), developed a specific manual for this project: \"Behavioral Sleep Intervention - SLEEP-OB - Therapist Support Manual.\" The manual was adapted based on CBT models for adults and adolescents with insomnia and on CBT for adolescents with other sleep disorders and comorbidities, namely obesity. The behavioral intervention aims to promote sustainable changes in sleep. It includes behavioral strategies (such as sleep restriction, stimulus control), cognitive strategies (cognitive reappraisal\u002Frestructuring, cognitive control, paradoxical intention), mixed strategies (sleep education\u002Fhygiene, relaxation), self-monitoring, and problem identification and resolution.\n\nThe intervention will take place over six months, with a total of seven sessions (in-person and by video call).",[15],[27,28],"Sleep intervention","Cognitive Behavioral Therapy for sleep disorders",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Standard Obesity Treatment","Standard obesity treatment for pediatric obesity according to international guidelines. It comprises pediatric appointments, and usually also nutrition and nursing appointments, every 2 to 3 months. These appointments include an anthropometric evaluation, physical examination and personalized multicomponent behavioral intervention with focus on nutrition, physical activity\u002Fsedentary behavior and other lifestyle recommendations. This standard intervention is common for both groups\u002Farms.",[9,15],[34],"treatment as usual",null,[37,69],{"facility":38,"status":39,"city":40,"state":35,"zip":35,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Unidade Local de Saúde Cova da Beira","RECRUITING","Covilha","Portugal","PT",{"type":44,"coordinates":45},"Point",[46,47],-7.50504,40.28106,{"lat":47,"lon":46},[50,55,58,61,64,66,67],{"name":51,"role":52,"phone":53,"phoneExt":35,"email":54},"Sofia Ferreira, MD","CONTACT","+351275330000","ana.sofia.ferreira@ubi.pt",{"name":56,"role":52,"phone":35,"phoneExt":35,"email":57},"Arminda Jorge, PhD in Medicine","ajorge@fcsaude.ubi.pt",{"name":59,"role":60,"phone":35,"phoneExt":35,"email":35},"Sofia Ferreira, Medical Doctor","PRINCIPAL_INVESTIGATOR",{"name":62,"role":63,"phone":35,"phoneExt":35,"email":35},"Marta Rodrigues, Medical Doctor, Master degree","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":35,"phoneExt":35,"email":35},"Nuno Lourenço, Medical Doctor, Master degree",{"name":56,"role":63,"phone":35,"phoneExt":35,"email":35},{"name":68,"role":63,"phone":35,"phoneExt":35,"email":35},"Ana Serra, Master in Psychology",{"facility":70,"status":71,"city":72,"state":35,"zip":35,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Hospital CUF Porto","NOT_YET_RECRUITING","Porto",{"type":44,"coordinates":74},[75,76],-8.61097,41.1485,{"lat":76,"lon":75},[79,82,83,85,87],{"name":80,"role":52,"phone":35,"phoneExt":35,"email":81},"Carla Rêgo, PhD in Medicine","carlambssrego@gmail.com",{"name":80,"role":60,"phone":35,"phoneExt":35,"email":35},{"name":84,"role":63,"phone":35,"phoneExt":35,"email":35},"Carla Laranjeira, Medical Doctor",{"name":86,"role":63,"phone":35,"phoneExt":35,"email":35},"Sofia Ramalho, PhD in Psychology",{"name":88,"role":63,"phone":35,"phoneExt":35,"email":35},"Margarida Gouveia, Master student in Psychology",{"type":60,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"ana sofia rodrigues ferreira","PhD student","100612568","overweight-and-obesity-in-adolescents---sleep-behavioral-intervention-100612568",false,"NCT07255274","Overweight and Obesity in Adolescents - Sleep Behavioral Intervention","Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB","SLEEP-OB","Inclusion Criteria:\n\n1. Informed consent from legal guardians and assent\u002Fconsent from the adolescent;\n2. Age between 13 and 17 years at the time of consent;\n3. Diagnosis of overweight (BMI z-score \\> 1 and ≤ 2) or obesity (BMI z-score \\> 2), according to WHO criteria;\n4. Sleep deprivation or poor sleep quality, based on the initial screening questionnaire.\n\nExclusion Criteria:\n\n1. Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes);\n2. Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep;\n3. Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep.","ALL","13 Years","17 Years",{"count":104,"type":105},126,"ESTIMATED","INTERVENTIONAL",[108],"NA","Sleep plays a crucial role in energy balance, alongside diet and physical activity. Research has linked poor sleep quality and short sleep duration to obesity and cardiometabolic risk, such as insulin resistance and hypertension. The nature of this association is complex, and several mechanims have been suggested.\n\nScientific evidence suggests that sleep interventions may provide additional benefits in optimizing the effectiveness of overweight\u002Fobesity treatment in pediatric populations. Although some studies have explored this hypothesis, methodological heterogeneity hampers clear interpretation of the results.\n\nThe main goal of this clinical trial is is to evaluate the efficacy of a sleep behavioral intervention, combined with standard obesity treatment, in reducing adiposity (measured by BMI z-score, fat mass percentage, or fat-free mass index) in adolescents with overweight or obesity.\n\nThis randomized controlled trial will compare a control group receiving treatment as usual (or standard obesity treatment) with an intervention group receiving treatment as usual plus a sleep behavioral intervention.\n\nParticipants will be randomized into two groups: intervention and control. Throughout the study period, all medical consultations will include standard interventions focused on nutrition, physical activity\u002Fsedentary behavior, and other lifestyle factors. The sleep-focused intervention will be delivered by psychologists.\n\nParticipants will attend clinic visits every two months during the 6-month intervention period, and every three months during the subsequent 6-month follow-up period.",[111,112],"Obesity and Overweight","Sleep Disorder",[114,115,116,117],"Obesity","Sleep","Behavioral intervention","Adolescents","2025-11-19",{"date":120,"type":121},"2025-12-01","ACTUAL",{"date":123,"type":121},"2025-06-03",{"date":125,"type":105},"2026-12",{"name":5,"class":6},2]