[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527454":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Drexel University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acceptance-based Treatment (ABT)","EXPERIMENTAL","ABT will consist of 18, 90-minute group sessions over 6 months.",[13],"Behavioral: Acceptance-based Treatment (ABT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Health Education (HE) Comparison","SHAM_COMPARATOR","HE will include nine, 75-minute group health education sessions handouts over 6 months.",[19],"Behavioral: Health Education (HE) Comparison",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives.",[15],[30],{"name":31,"affiliation":5,"role":32},"Stephanie Manasse, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","215-553-7157","smm522@drexel.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-75.16362,39.95238,{"lat":50,"lon":49},[53],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"type":32,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Stephanie Manasse","Assistant Professor","100527454","an-acceptance-based-healthy-lifestyle-intervention-for-diverse-adolescents-100527454",false,"NCT06147973","An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents","Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents","Inclusion Criteria:\n\n* Ages 14-19\n* Gender identification as girl\n* BMI percentile ≥ 85th percentile for sex-and-age\n\nExclusion Criteria:\n\n* Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss\n* Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months\n* Plans to move out of the area within the next year\n* Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)\n* Active or chronic infections (e.g., HIV or TB)\n* Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months\n* Active kidney disease\n* History of bariatric surgery\n* Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)\n* Diagnosed diabetes (type 1 or 2)\n* Any condition prohibiting physical activity\n* Diagnosis of an eating disorder\n* Have a mental handicap or are currently experiencing other severe psychopathology that would limit their ability to engage in the treatment program (e.g., severe depression, active psychotic disorder)\n* Recent or ongoing problem with drug abuse, alcohol abuse, or addiction\n* Currently pregnant or less than 3 months post-partum\n* Anticipation of a possible pregnancy in the next year\n* Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial",true,"FEMALE","14 Years","19 Years",{"count":69,"type":70},148,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight\u002Fobesity. The main questions this trial aims to answer are:\n\n1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?\n2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention?\n\nParticipants in this trial will:\n\n1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform.\n2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity.\n\nResearchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.",[76],"Overweight and Obesity",[78,79,80,81],"adolescent obesity","cardiovascular disease risk","healthy lifestyle intervention","acceptance-based","2024-04-09",{"date":84,"type":85},"2024-04-10","ACTUAL",{"date":87,"type":85},"2024-02-14",{"date":89,"type":70},"2028-01-01",{"name":5,"class":6},1]