[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532000":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":100,"collaborators":103,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":62,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":70,"whyStopped":62,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Regulation of Cues","EXPERIMENTAL","The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.",[13],"Behavioral: Regulation of Cues",{"label":15,"type":16,"description":17,"interventionNames":18},"Family-Based Treatment","ACTIVE_COMPARATOR","The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.",[19],"Behavioral: Family Based Behavioral Treatment",{"label":21,"type":10,"description":22,"interventionNames":23},"Regulation of Cues +","The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake",[24],"Behavioral: Regulation of Cues +",{"label":26,"type":16,"description":27,"interventionNames":28},"Health Education","The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.",[29],"Behavioral: Health Education",[31,37,43,48],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.",[9],[36],"ROC",{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Family Based Behavioral Treatment","FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.",[15],[42],"FBT",{"type":32,"name":21,"description":44,"armGroupLabels":45,"otherNames":46},"ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake",[21],[47],"ROC+",{"type":32,"name":26,"description":27,"armGroupLabels":49,"otherNames":50},[26],[51],"HE",[53],{"name":54,"affiliation":55,"role":56},"Kerri Boutelle, Ph.D.","UC San Diego","PRINCIPAL_INVESTIGATOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Kaylen Moline, MPH","CONTACT","1-855-827-3498",null,"chear@ucsd.edu",{"name":54,"role":60,"phone":65,"phoneExt":62,"email":66},"858-249-3528","kboutelle@ucsd.edu",[68,85],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"UC San Diego Center for Healthy Eating and Activity Research (CHEAR)","RECRUITING","La Jolla","California","92037","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-117.2742,32.84727,{"lat":80,"lon":79},[83],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":84},"chear@health.ucsd.edu",{"facility":86,"status":70,"city":87,"state":88,"zip":89,"country":74,"countryCode":75,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Ambulatory Research Center - University of Minnesota","Minneapolis","Minnesota","55454",{"type":77,"coordinates":91},[92,93],-93.26384,44.97997,{"lat":93,"lon":92},[96],{"name":97,"role":60,"phone":98,"phoneExt":62,"email":99},"Carol Peterson, Ph.D.","612-273-9811","peter161@umn.edu",{"type":56,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"Kerri Boutelle","Kerri Boutelle, Ph.D.,, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science",[104,106],{"name":105,"class":6},"University of Minnesota",{"name":107,"class":108},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100532000","family-responsibility-education-support-and-health-for-food-responsiveness-100532000",false,"NCT06207110","Family, Responsibility, Education, Support, and Health for Food Responsiveness","Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat","FRESH-FR","Inclusion Criteria:\n\n1. Informed assent and parental consent\n2. A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age\n3. Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.\n4. A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level\n5. Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments\n6. Child is on stable medication regimen for medications that can impact weight (3+ months)\n7. Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity\n\nExclusion Criteria:\n\n1. Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)\n2. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted\n3. Child who is taking medication for weight loss\n4. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)\n5. First degree relative or someone in the household with anorexia or bulimia nervosa.\n\nPotential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.",true,"ALL","7 Years","12 Years",{"count":122,"type":123},280,"ESTIMATED","INTERVENTIONAL",[126],"NA","The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).",[129],"Obesity, Childhood",[131,132,133,134],"Food Responsiveness","Satiety Responsiveness","Weight Loss","Overeating","2025-05-06",{"date":137,"type":138},"2025-05-11","ACTUAL",{"date":140,"type":138},"2024-04-03",{"date":142,"type":123},"2029-01-01",{"name":5,"class":6},2]