Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men (STRONG)

An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Metabolic Syndrome; Prostate Cancer
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20003
      • Office of Minority Health and Health Disparities Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. African-American and/or Black men;
2. between the ages of 40-70 years;
3. waist circumference >40 inches (102 cm);
4. with at least two of the following: elevated BP (≥ 130/85 mmHg);
5. elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);
6. sedentary defined as <60 minutes of recreation or work requiring modest PA/week;
7. be able to speak and read English;
8. able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);
9. have no physical limitations that prevent from exercising;
10. and have access to a television and DVD player.

Exclusion Criteria:

1. history of cancer except nonmelanoma skin cancer;
2. current enrollment in another clinical trial or weight loss program;
3. inability to commit to the intervention schedule. Prior to randomization, participants will be required to have a signed authorization and medical clearance from their personal physician or our nurse practitioner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.	Behavioral: Exercise; 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.
Active Comparator: Attention Control Group; Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.	Behavioral: Attention Control; We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference will be measured at baseline, 3- and 6-months of the intervention	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary behaviors questionnaire	Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention	6-months
Cardiovascular fitness test	Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.	6-months
Fasting glucose levels test	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.	6-months
Lipid level test	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.	6-months
Quality of life questionnaire (SF-36)	Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.	6-months
Body Mass Index (BMI)	Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.	6-months

Collaborators and Investigators

• Sponsor: Georgetown University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 16, 2017
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; prostate cancer; Metabolic Syndrome; African-American; Men's Health
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease; Genital Neoplasms, Male; Prostatic Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Prostatic Neoplasms; Metabolic Syndrome
• Other Study ID Numbers: Georgetown_University_MC1