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临床试验/NCT06827704
NCT06827704进行中(未招募)不适用

Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in South Asian Indian Immigrant Women

Rush University Medical Center5 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
96
试验地点
5
主要终点
Physical Activity- Steps/day

研究概览

简要总结

This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.

详细描述

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<.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<.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 <150 minutes/week of moderate-intensity or <75 minutes/week 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/day [ActiGraph], minutes of moderate to vigorous physical activity/week (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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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 <150 minutes/week of moderate-intensity or <75 minutes/week 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)

排除标准

  • Major signs/symptoms 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/or diastolic BP ≥100

研究组 & 干预措施

Enhanced physical activity monitor which is Fitbit watch with mobile App

Experimental

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).

干预措施: Enhanced physical activity monitor which is Fitbit watch with mobile App (Behavioral)

Bollywood-style group dance

Experimental

Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x/week for 6 months.

干预措施: Bollywood-style group dance (Behavioral)

PAMDance

Experimental

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/week for 6 months.

干预措施: PAMDance (Behavioral)

Usual care control

No Intervention

Participants in the usual care group do not receive any PAM or Dance related intervention.

结局指标

主要结局

Physical Activity- Steps/day

时间窗: Baseline plus change will be assessed at weeks 12 and 24.

Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on lifestyle PA (steps/day \[ActiGraph\] in midlife SAI women.

Physical Activity- Moderate to Vigorous Physical Activity (MVPA)/day

时间窗: Baseline plus change will be assessed at weeks 12 and 24.

Determine the independent and combined efficacies of PAM and Dance at 12 and 24 weeks on minutes of Moderate to Vigorous Physical Activity (MVPA)/day (ActiGraph and self-report) in midlife SAI women.

次要结局

  • Metabolic outcomes (1)(Baseline plus change will be assessed at weeks 12 and 24.)
  • Metabolic outcomes (3)(Baseline plus change will be assessed at weeks 12 and 24.)
  • Metabolic outcomes (2)(Baseline plus change will be assessed at weeks 12 and 24.)
  • Metabolic outcomes (4)(Baseline plus change will be assessed at weeks 12 and 24.)
  • Metabolic outcomes (5)(Baseline plus change will be assessed at weeks 12 and 24.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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