Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in SAI Women

Not Applicable

Not yet recruiting

• Conditions: Metabolic Syndrome; Physical Activity; Breast Cancer Prevention

• Registration Number: NCT06827704
• Lead Sponsor: Rush University Medical Center

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 Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-04-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Physical Activity- Steps/day	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	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 Outcome Measures

Name	Time	Method
Metabolic outcomes (1)	Baseline plus change will be assessed at weeks 12 and 24.	Blood pressure
Metabolic outcomes (3)	Baseline plus change will be assessed at weeks 12 and 24.	Lipid panel : point-of-care total cholesterol, triglycerides, HDL, LDL
Metabolic outcomes (2)	Baseline plus change will be assessed at weeks 12 and 24.	Blood glucose: point-of-care HbA1C
Metabolic outcomes (4)	Baseline plus change will be assessed at weeks 12 and 24.	Body composition: BMI (weight measured in pounds; height measured in inches)
Metabolic outcomes (5)	Baseline plus change will be assessed at weeks 12 and 24.	Body composition: waist measured in inches

Trial Locations

Locations (1)

Rush University College of Nursing; 🇺🇸 Chicago, Illinois, United States