[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510749":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":58,"centralContacts":63,"locations":69,"responsibleParty":85,"collaborators":87,"id":91,"slug":49,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":49,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":49,"enrollmentInfo":99,"targetDuration":49,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":49,"overallStatus":71,"whyStopped":49,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fred Hutchinson Cancer Center","OTHER",[8,14,19,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!","EXPERIMENTAL","Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! in Stage 1 and were responders (≥2% weight loss at 8 weeks).\n\nIn Stage 2, responders receive additional ¡Vida! intervention programming.",[13],"Behavioral: ¡Vida! program",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus","Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (\\\u003C2% weight loss at 8 weeks).\n\nIn Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL).",[13,18],"Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)","Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (\\\u003C2% weight loss at 8 weeks).\n\nIn Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.",[13,18,23],"Behavioral: Health Coaching",{"label":25,"type":10,"description":26,"interventionNames":27},"Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus","Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks).\n\nIn Stage 2, responders receive additional ¡Vida! Plus intervention programming.",[13,18],{"label":29,"type":10,"description":30,"interventionNames":31},"Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)","Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (\\\u003C2% weight loss at 8 weeks).\n\nIn Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching.",[13,18,23],{"label":33,"type":10,"description":34,"interventionNames":35},"Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits","Participants participate in the online ¡Vida! program of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions, and receive a mailed toolkit of health items twice on study. Participants also undergo blood sample collection on study.\n\nThis arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (\\\u003C2% weight loss at 8 weeks).\n\nIn Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching (HC) as well as mailed toolkits (MT).",[13,18,23,36],"Behavioral: Mailed Toolkits",[38,45,50,54],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BEHAVIORAL","¡Vida! program","Participate in ¡Vida! program",[9,15,20,25,29,33],[44],"Behavioral Intervention",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"¡Vida! Plus [¡Vida! + Experiential Learning (EL)]","Participate in ¡Vida! Plus program",[15,20,25,29,33],null,{"type":39,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Health Coaching","Receive health coaching",[20,29,33],{"type":39,"name":55,"description":56,"armGroupLabels":57,"otherNames":49},"Mailed Toolkits","Receive a mailed toolkit of health items",[33],[59],{"name":60,"affiliation":61,"role":62},"Heather Greenlee","Fred Hutch\u002FUniversity of Washington Cancer Consortium","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":49,"email":68},"Jenny Whitten-Brannon","CONTACT","206-667-5625","jwhitten@fredhutch.org",[70],{"facility":61,"status":71,"city":72,"state":73,"zip":74,"country":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Seattle","Washington","98109","United States",{"type":77,"coordinates":78},"Point",[79,80],-122.33207,47.60621,{"lat":80,"lon":79},[83,84],{"name":65,"role":66,"phone":67,"phoneExt":49,"email":68},{"name":60,"role":62,"phone":49,"phoneExt":49,"email":49},{"type":86,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[88],{"name":89,"class":90},"National Cancer Institute (NCI)","NIH","100510749",false,"NCT05930483","Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial","Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study","Inclusion Criteria:\n\n* Biologically female\n* Age \\>= 18 years\n* Self-identifies Hispanic\u002FLatina\n* Able to read and write in Spanish and\u002For English\n* Previous diagnosis of stage I-III BC within the past 5 years\n* No evidence of current, recurrent, or metastatic disease\n* 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4\u002F6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)\n* Body mass index (BMI) \\>= 27 kg\u002Fm\\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Willingness to participate in all study activities\n* Access to phone for study contacts\n* Access to internet to participate in the online program and to be able to sync study devices\n* Successful completion of at-home baseline assessments prior to randomization\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 27 kg\u002Fm\\^2 at time of baseline data collection\n* Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)\n* Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline\n* Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \\[T-DM1\\], trastuzumab deruxtecan \\[T-DXd\\])\n* Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA\n* Pregnant, breastfeeding, or planning to become pregnant during the study period\n* Use of exogenous hormones for gender affirmation\n* For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months\n* For stool sample collection only: Presence of self-reported ileostomy or colostomy\n* For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)\n* Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.\n* Concurrent enrollment in another weight loss or physical activity trial","FEMALE","18 Years",{"count":100,"type":101},640,"ESTIMATED","INTERVENTIONAL",[104],"NA","This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight\u002Fobesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.",[107,108,109],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","2026-06-16",{"date":112,"type":113},"2026-06-18","ACTUAL",{"date":115,"type":113},"2025-04-08",{"date":117,"type":101},"2028-03-01",{"name":5,"class":6},1]