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Behavioral Intervention
Physical Activity for Breast Cancer (MetS-BC Trial)
Chicago, IL
N/A
Waitlist Available
Led By Manju Daniel, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline plus change will be assessed at weeks 12 and 24.
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to help South Asian Indian immigrant women improve their physical activity and metabolic health to prevent breast cancer."
See full description
Who is the study for?
This trial is for first-generation South Asian Indian women aged 40-65 living in the US, without breast cancer but at risk due to low physical activity and metabolic syndrome. Participants must be able to use a Fitbit with an app, join virtual sessions, and have no disabilities that prevent regular exercise.Check my eligibility
What is being tested?
The study tests if using a Fitbit watch with an app and participating in Bollywood-style dance classes (PAMDance) can boost physical activity and improve metabolic health to help prevent breast cancer.See study design
What are the potential side effects?
There may not be direct side effects from the interventions since they involve physical activities. However, participants might experience typical exercise-related discomforts such as muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes with specific A1C levels or no prior diagnosis but an A1C of ≥ 6.5%.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had serious heart, lung problems, or walking issues in the last month.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline plus change will be assessed at weeks 12 and 24.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline plus change will be assessed at weeks 12 and 24.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physical Activity- Moderate to Vigorous Physical Activity (MVPA)/day
Physical Activity- Steps/day
Secondary study objectives
Metabolic outcomes (1)
Metabolic outcomes (2)
Metabolic outcomes (3)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: PAMDanceExperimental Treatment1 Intervention
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 II: Enhanced physical activity monitor which is Fitbit watch with mobile AppExperimental Treatment1 Intervention
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 III: Bollywood-style group danceExperimental Treatment1 Intervention
Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x/week for 6 months.
Group IV: Usual care controlActive Control1 Intervention
Participants in the usual care group do not receive any PAM or Dance related intervention.
Find a Location
Closest Location:Rush University College of Nursing· Chicago, IL· 276 miles
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
444 Previous Clinical Trials
246,304 Total Patients Enrolled
Manju Daniel, PhDPrincipal InvestigatorRush University College of Nursing