Clinical trial NCT06827704: Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in SAI Women
Official title: Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in South Asian Indian Immigrant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Breast Cancer Prevention
Physical Activity
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 96
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Physical Activity- Steps/day
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
measure: Physical Activity- Moderate to Vigorous Physical Activity (MVPA)/day
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
Secondary outcomes:
measure: Metabolic outcomes (1)
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
measure: Metabolic outcomes (2)
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
measure: Metabolic outcomes (3)
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
measure: Metabolic outcomes (4)
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
measure: Metabolic outcomes (5)
timeFrame: Baseline plus change will be assessed at weeks 12 and 24.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University College of Nursing
state: Illinois
Study officials:
affiliation: Rush University College of Nursing
name: Manju Daniel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.