[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06827704":3,"trial-entities:NCT06827704":133,"trial-summary:NCT06827704":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":52,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":85,"locations":88,"central_contacts":104,"overall_officials":105,"references":109,"see_also_links":132},"NCT06827704","24032906-IRB01","Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in SAI Women","Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in South Asian Indian Immigrant Women","ACTIVE_NOT_RECRUITING","2026-12-31","2026-07","2026-07-31","2025-05-01","Rush University Medical Center","OTHER",true,"This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.","One out of every eight SAI women in the US is at risk of developing breast cancer and breast cancer manifests 5-10 years earlier in South Asian Indian immigrant (SAI) women (54.5 \\[SD =13.3\\]) than in their non-Hispanic White women counterparts (p\\\u003C.01). The risk of breast cancer is 2.3 times higher in SAI women with metabolic syndrome (hypertension, insulin resistance, dyslipidemia, and central obesity (HR 2.30, 95% CI 1.18-4.49) than their non-Hispanic White women counterparts. To reduce disparities related to metabolic syndrome associated breast cancer in at-risk SAI women, increasing lifestyle physical activity is critical. Approximately 50% of first-generation SAI women in the US, fail to meet recommended physical activity guidelines. Western leisure-time activities lack the cultural connection for many SAI women due to language issue, perceived racial discrimination, and a limited sense of community. To address disparities related to physical activity barriers, the physical activity interventions must be culturally tailored to promote their uptake among at-risk first-generation midlife SAI women. In-person culturally tailored program with Bollywood-style group dance and goal setting with a physical activity monitor have been shown to significantly improve average daily steps, self-efficacy, blood pressure, blood glucose, lipids, body weight, and waist circumference (p\\\u003C.05) in first-generation midlife SAI women. However, lack of time due to role expectations at home and lack of transportation presented a challenge for SAI women to attend in-person behavioral group activities. Therefore, the purpose of this virtual 24-week culturally relevant physical activity program with 2x2 factorial design is to improve physical activity and metabolic outcomes for breast cancer prevention in first-generation midlife (aged 40-65) SAI women with insufficient physical activity (self-reported \\\u003C150 minutes\u002Fweek of moderate-intensity or \\\u003C75 minutes\u002Fweek of vigorous-intensity physical activity in the past month). Women (N=96) will be randomized into one of four conditions 1) Enhanced physical activity monitor which is Fitbit watch with mobile App (PAM), 2) Bollywood-style group dance (Dance), 3) PAMDance, or 4) usual care control. This study aims to: (1) Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on lifestyle physical activity (steps\u002Fday \\[ActiGraph\\], minutes of moderate to vigorous physical activity\u002Fweek (ActiGraph and self-report) in midlife SAI women; (2) Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on metabolic outcomes (blood pressure, blood glucose, lipids, body mass index, and waist circumference). We expect that our findings will demonstrate the efficacy of a virtual culturally tailored lifestyle behavioral physical activity intervention to be broadly applicable for addressing metabolic disparities that confer increased risk for breast cancer in first-generation midlife SAI women.",[19,20,21],"Metabolic Syndrome","Breast Cancer Prevention","Physical Activity",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},96,"ESTIMATED",[31,36,40],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Enhanced physical activity monitor which is Fitbit watch with mobile App","Participants will receive an enhanced physical activity monitor treatment for 6 months which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor (Fitbit watch). Edit",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Bollywood-style group dance","Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x\u002Fweek for 6 months",[37],{"type":32,"name":41,"description":42,"armGroupLabels":43},"PAMDance","Participants will receive an enhanced physical activity monitor treatment for 6 months which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor (Fitbit watch). In addition, Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x\u002Fweek for 6 months",[41],[45,49],{"measure":46,"description":47,"timeFrame":48},"Physical Activity- Steps\u002Fday","Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on lifestyle PA (steps\u002Fday \\[ActiGraph\\] in midlife SAI women.","Baseline plus change will be assessed at weeks 12 and 24.",{"measure":50,"description":51,"timeFrame":48},"Physical Activity- Moderate to Vigorous Physical Activity (MVPA)\u002Fday","Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on minutes of Moderate to Vigorous Physical Activity (MVPA)\u002Fday (ActiGraph and self-report) in midlife SAI women.",[53,56,59,62,65],{"measure":54,"description":55,"timeFrame":48},"Metabolic outcomes (1)","Blood pressure",{"measure":57,"description":58,"timeFrame":48},"Metabolic outcomes (2)","Blood glucose: point-of-care HbA1C",{"measure":60,"description":61,"timeFrame":48},"Metabolic outcomes (3)","Lipid panel : point-of-care total cholesterol, triglycerides, HDL, LDL",{"measure":63,"description":64,"timeFrame":48},"Metabolic outcomes (4)","Body composition: BMI (weight measured in pounds; height measured in inches)",{"measure":66,"description":67,"timeFrame":48},"Metabolic outcomes (5)","Body composition: waist measured in inches","FEMALE","40 Years","65 Years",{"inclusion":72,"exclusion":81,"raw_text":84},[73,74,75,76,77,78,79,80],"Self-identified first-generation SAI woman aged 40-65 years without breast cancer diagnosis (permanent residency in US or are in the process of obtaining permanent residency)","Insufficiently active (self-reported \\\u003C150 minutes\u002Fweek of moderate-intensity or \\\u003C75 minutes\u002Fweek of vigorous-intensity PA in the past month)","Conversant in Hindi","Owns a smartphone for Fitbit application","Has a computer or mobile device with Internet access","Willing to participate in recorded Virtual intervention sessions","Medical clearance if has Type 1 diabetes, or Type 2 diabetes with an A1C ≥ 9.0%, or have an A1C of ≥ 6.5% without a prior diabetes diagnosis","Has no disabilities preventing regular PA determined by Physical Activity Readiness Questionnaire (PAR-Q \\& You)",[82,83],"Major signs\u002Fsymptoms of pulmonary or CVD, unstable cardiac or pulmonary disease in the past month, or other conditions interfering with walking (per PAR-Q \\& You)","Systolic BP ≥160 and\u002For diastolic BP ≥100","Inclusion Criteria:\n\n* Self-identified first-generation SAI woman aged 40-65 years without breast cancer diagnosis (permanent residency in US or are in the process of obtaining permanent residency)\n* Insufficiently active (self-reported \\\u003C150 minutes\u002Fweek of moderate-intensity or \\\u003C75 minutes\u002Fweek of vigorous-intensity PA in the past month)\n* Conversant in Hindi\n* Owns a smartphone for Fitbit application\n* Has a computer or mobile device with Internet access\n* Willing to participate in recorded Virtual intervention sessions\n* Medical clearance if has Type 1 diabetes, or Type 2 diabetes with an A1C ≥ 9.0%, or have an A1C of ≥ 6.5% without a prior diabetes diagnosis\n* Has no disabilities preventing regular PA determined by Physical Activity Readiness Questionnaire (PAR-Q \\& You)\n\nExclusion Criteria:\n\n* Major signs\u002Fsymptoms of pulmonary or CVD, unstable cardiac or pulmonary disease in the past month, or other conditions interfering with walking (per PAR-Q \\& You)\n* Systolic BP ≥160 and\u002For diastolic BP ≥100",[86,87],"ADULT","OLDER_ADULT",[89,98],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Rush University College of Nursing","Chicago","Illinois","60612","United States",{"lat":96,"lon":97},41.85003,-87.65005,{"facility":90,"city":99,"state":92,"zip":100,"country":94,"geoPoint":101},"Sugar Grove","60554",{"lat":102,"lon":103},41.76142,-88.44369,[],[106],{"name":107,"affiliation":90,"role":108},"Manju Daniel, PhD","PRINCIPAL_INVESTIGATOR",[110,114,117,120,123,126,129],{"pmid":111,"type":112,"citation":113},"21818758","BACKGROUND","Daniel M, Miller A, Wilbur J. Multiple instrument translation for use with South Asian Indian immigrants. Res Nurs Health. 2011 Oct;34(5):419-32. doi: 10.1002\u002Fnur.20450. Epub 2011 Aug 4.",{"pmid":115,"type":112,"citation":116},"28281387","Daniel M, Abendroth M, Erlen JA. Barriers and Motives to PA in South Asian Indian Immigrant Women. West J Nurs Res. 2018 Sep;40(9):1339-1356. doi: 10.1177\u002F0193945917697218. Epub 2017 Mar 10.",{"pmid":118,"type":112,"citation":119},"33540381","Daniel M, Marquez D, Ingram D, Fogg L. Group Dance and Motivational Coaching for Walking: A Physical Activity Program for South Asian Indian Immigrant Women Residing in the United States. J Phys Act Health. 2021 Mar 1;18(3):262-271. doi: 10.1123\u002Fjpah.2019-0316. Epub 2021 Feb 4.",{"pmid":121,"type":112,"citation":122},"24219639","Daniel M, Wilbur J, Fogg LF, Miller AM. Correlates of lifestyle: physical activity among South Asian Indian immigrants. J Community Health Nurs. 2013;30(4):185-200. doi: 10.1080\u002F07370016.2013.838482.",{"pmid":124,"type":112,"citation":125},"23686529","Daniel M, Wilbur J, Marquez D, Farran C. Lifestyle physical activity behavior among South Asian Indian immigrants. J Immigr Minor Health. 2013 Dec;15(6):1082-9. doi: 10.1007\u002Fs10903-013-9842-4.",{"pmid":127,"type":112,"citation":128},"22092422","Daniel M, Wilbur J. Physical activity among South Asian Indian immigrants: an integrative review. Public Health Nurs. 2011 Sep-Oct;28(5):389-401. doi: 10.1111\u002Fj.1525-1446.2010.00932.x. Epub 2011 May 9.",{"pmid":130,"type":112,"citation":131},"36324264","Daniel M, Buchholz S, Fogg L. Physical Activity in South Asian Indians: A Systematic Review of Randomized Controlled Trials. West J Nurs Res. 2023 Apr;45(4):363-374. doi: 10.1177\u002F01939459221134373. Epub 2022 Nov 2.",[],{"nct_id":4,"conditions":134,"biomarkers":136},[135,19],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 96 women.","completed","Physical Activity for Breast Cancer Prevention in South Asian Indian Women","This study is looking at ways to prevent breast cancer in South Asian Indian (SAI) immigrant women who have metabolic syndrome (a group of conditions that increase your risk of heart disease, stroke, and diabetes). Researchers want to see if increasing physical activity can help. You would receive either an enhanced physical activity monitor (a Fitbit watch with a mobile app) or participate in Bollywood-style group dance sessions. The study aims to improve your physical activity levels, measured by steps per day and moderate to vigorous physical activity per day. The study is currently unclear about its recruitment status and plans to enroll 96 women.","Physical activity will be assessed at 12 and 24 weeks after the start of the study.",105,"Participants will receive an enhanced physical activity monitor for 6 months or participate in 60-minute virtual dance sessions twice a week for 6 months. Physical activity will be measured at the beginning, at 12 weeks, and at 24 weeks.","Not stated in the trial record.",[37],"v2"]