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Clinical Trials/NCT06827704
NCT06827704Active, not recruitingNot Applicable

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

Rush University Medical Center3 sites in 1 country96 target enrollmentStarted: May 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
96
Locations
3
Primary Endpoint
Physical Activity- Steps/day

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Arms & Interventions

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).

Intervention: 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.

Intervention: 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.

Intervention: PAMDance (Behavioral)

Usual care control

No Intervention

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

Outcomes

Primary Outcomes

Physical Activity- Steps/day

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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