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Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men (STRONG)

Primary Purpose

Physical Activity, Metabolic Syndrome, Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Attention Control

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring prostate cancer, African-American, Metabolic Syndrome, Exercise, Men's Health

Eligibility Criteria

40 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

history of cancer except nonmelanoma skin cancer;
current enrollment in another clinical trial or weight loss program;
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.

Sites / Locations

Office of Minority Health and Health Disparities Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Group

Attention Control Group

Arm Description

Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.

Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.

Outcomes

Primary Outcome Measures

Waist circumference

Waist circumference will be measured at baseline, 3- and 6-months of the intervention

Secondary Outcome Measures

Dietary behaviors questionnaire

Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention

Cardiovascular fitness test

Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.

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.

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.

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.

Body Mass Index (BMI)

Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.

Full Information

NCT ID

NCT02379559

First Posted

September 23, 2014

Last Updated

February 17, 2017

Sponsor

Georgetown University

1. Study Identification

Unique Protocol Identification Number

NCT02379559

Brief Title

Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

Acronym

STRONG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

February 16, 2017 (Actual)

Study Completion Date

February 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Activity, Metabolic Syndrome, Prostate Cancer

Keywords

prostate cancer, African-American, Metabolic Syndrome, Exercise, Men's Health

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Group

Arm Type

Experimental

Arm Description

Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.

Arm Title

Attention Control Group

Arm Type

Active Comparator

Arm Description

Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Attention Control

Intervention Description

We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.

Primary Outcome Measure Information:

Title

Waist circumference

Description

Waist circumference will be measured at baseline, 3- and 6-months of the intervention

Time Frame

6-months

Secondary Outcome Measure Information:

Title

Dietary behaviors questionnaire

Description

Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention

Time Frame

6-months

Title

Cardiovascular fitness test

Description

Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.

Time Frame

6-months

Title

Fasting glucose levels test

Description

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

Title

Lipid level test

Description

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

Title

Quality of life questionnaire (SF-36)

Description

Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.

Time Frame

6-months

Title

Body Mass Index (BMI)

Description

Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.

Time Frame

6-months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: African-American and/or Black men; between the ages of 40-70 years; waist circumference >40 inches (102 cm); with at least two of the following: elevated BP (≥ 130/85 mmHg); elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL); sedentary defined as <60 minutes of recreation or work requiring modest PA/week; be able to speak and read English; able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded); have no physical limitations that prevent from exercising; and have access to a television and DVD player. Exclusion Criteria: history of cancer except nonmelanoma skin cancer; current enrollment in another clinical trial or weight loss program; 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.

Facility Information:

Facility Name

Office of Minority Health and Health Disparities Research

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20003

Country

United States

12. IPD Sharing Statement

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Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

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