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

NCT ID: NCT06827704

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-31

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.

Conditions

Metabolic Syndrome; Breast Cancer Prevention; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Enhanced physical activity monitor which is Fitbit watch with mobile App

Intervention Type: BEHAVIORAL

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

Bollywood-style group dance

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

Group Type: EXPERIMENTAL

Bollywood-style group dance

Intervention Type: BEHAVIORAL

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

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/week for 6 months.

Group Type: EXPERIMENTAL

PAMDance

Intervention Type: BEHAVIORAL

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

Usual care control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Bollywood-style group dance

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

Intervention Type: BEHAVIORAL

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/week for 6 months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manju Daniel, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University College of Nursing

Locations

Rush University College of Nursing

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

Rush University College of Nursing

Sugar Grove, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Manju Daniel, PhD

Role: CONTACT

manju_n_daniel@rush.edu

13314542960

Facility Contacts

Manju Daniel, PhD

Role: primary

manju_n_daniel@rush.edu

331-454-2960

Manju Daniel, PhD

Role: primary

manju_n_daniel@rush.edu

331-454-2960

References

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/nur.20450. Epub 2011 Aug 4.

Reference Type: BACKGROUND

PMID: 21818758 (View on PubMed)

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: 10.1177/0193945917697218. Epub 2017 Mar 10.

Reference Type: BACKGROUND

PMID: 28281387 (View on PubMed)

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/jpah.2019-0316. Epub 2021 Feb 4.

Reference Type: BACKGROUND

PMID: 33540381 (View on PubMed)

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: 10.1080/07370016.2013.838482.

Reference Type: BACKGROUND

PMID: 24219639 (View on PubMed)

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/s10903-013-9842-4.

Reference Type: BACKGROUND

PMID: 23686529 (View on PubMed)

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/j.1525-1446.2010.00932.x. Epub 2011 May 9.

Reference Type: BACKGROUND

PMID: 22092422 (View on PubMed)

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: 10.1177/01939459221134373. Epub 2022 Nov 2.

Reference Type: BACKGROUND

PMID: 36324264 (View on PubMed)

Other Identifiers

DUNS: 068610245

Identifier Type: OTHER

Identifier Source: secondary_id

24032906-IRB01

Identifier Type: -

Identifier Source: org_study_id