Physical Activity Targeting Metabolic Syndrome for Prevention of Breast Cancer in SAI Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorRush University Medical Center
About this trial
This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Enhanced physical activity monitor which is Fitbit watch with mobile App
BehavioralParticipants 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
BehavioralParticipants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x/week for 6 months
PAMDance
BehavioralParticipants 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
Treatment groups
96 Participants
are divided into 4 treatment groupsGroup A: Enhanced physical activity monitor which is Fitbit watch with mobile AppExperimental treatment 1 intervention
Group B: Bollywood-style group danceExperimental treatment 1 intervention
Group C: PAMDanceExperimental treatment 1 intervention
Group D: Usual care controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline plus change will be assessed at weeks 12 and 24.2
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.
Time frame
Baseline plus change will be assessed at weeks 12 and 24.Secondary outcomes
1
Metabolic outcomes (1)
Blood pressure
Time frame
Baseline plus change will be assessed at weeks 12 and 24.2
Metabolic outcomes (2)
Blood glucose: point-of-care HbA1C
Time frame
Baseline plus change will be assessed at weeks 12 and 24.3
Metabolic outcomes (3)
Lipid panel : point-of-care total cholesterol, triglycerides, HDL, LDL
Time frame
Baseline plus change will be assessed at weeks 12 and 24.4
Metabolic outcomes (4)
Body composition: BMI (weight measured in pounds; height measured in inches)
Time frame
Baseline plus change will be assessed at weeks 12 and 24.Sponsors and contacts
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Source ClinicalTrials.gov