Office of Minority Health and Health Disparities Research
Washington D.C., District of Columbia, 20003, United States
NCT Number: NCT02379559
The main purpose of this study is to examine the feasibility of an exercise intervention on metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men with MetS who are at increased risk of prostate cancer.
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Notify Me40 year–40 year
Male
Interventional
Not applicable
Washington D.C., District of Columbia, 20003, United States
The specific aim for the proposed study is to examine the feasibility and impact of a 6-month two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate cancer, this proposal will focus on the impact of an aerobic and resistance exercise intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically, our proposed clinical trial compares an aerobic and resistance exercise intervention to an attention control group among Black men.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.
We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.
Time frame: 6-months
Waist circumference will be measured at baseline, 3- and 6-months of the intervention
Time frame: 6-months
Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention
Time frame: 6-months
Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.
Time frame: 6-months
Fasting blood sample via finger sticks will be administered by a phlebotomist to measure fasting glucose levels at baseline, 3- and 6-months of the intervention.
Time frame: 6-months
Fasting blood sample via finger sticks will be administered by a phlebotomist to measure lipid levels at baseline, 3- and 6-months of the intervention.
Time frame: 6-months
Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.
Time frame: 6-months
Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.
Georgetown University
Other
An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men
Acronym: STRONG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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