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

NCT06827704 | Recruiting DMC

• 2 other identifiers: 24032906-IRB01DUNS: 068610245
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Metabolic Syndrome; Breast Cancer Prevention; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Physical Activity- Steps/day

  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.

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

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

  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.

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

Secondary Outcomes (5)

• Metabolic outcomes (1)

  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 (3)

  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.

Study Arms (4)

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).

Behavioral: Enhanced physical activity monitor which is Fitbit watch with mobile App

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.

Behavioral: Bollywood-style group dance

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.

Behavioral: PAMDance

Usual care control

NO INTERVENTION

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

Interventions

Enhanced physical activity monitor which is Fitbit watch with mobile App 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

Enhanced physical activity monitor which is Fitbit watch with mobile App

Bollywood-style group dance BEHAVIORAL

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

Bollywood-style group dance

PAMDance 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

PAMDance

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Self-identified first-generation South Asian Indian immigrant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (2)

Rush University College of Nursing

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Rush University College of Nursing

Sugar Grove, Illinois, 60554, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 21818758 BACKGROUND

• 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.

  PMID: 28281387 BACKGROUND

• 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.

  PMID: 33540381 BACKGROUND

• 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.

  PMID: 24219639 BACKGROUND

• 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.

  PMID: 23686529 BACKGROUND

• 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.

  PMID: 22092422 BACKGROUND

• 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.

  PMID: 36324264 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Manju Daniel, PhD

  Rush University College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manju Daniel, PhD

CONTACT

13314542960; manju_n_daniel@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)