NCT02379559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2017

Completed
Last Updated

February 23, 2017

Status Verified

September 1, 2014

Enrollment Period

3.6 years

First QC Date

September 23, 2014

Last Update Submit

February 17, 2017

Conditions

Physical ActivityMetabolic SyndromeProstate Cancer

Keywords

prostate cancerAfrican-AmericanMetabolic SyndromeExerciseMen's Health

Outcome Measures

Primary Outcomes (1)

  • Waist circumference

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

    6-months

Secondary Outcomes (6)

  • Dietary behaviors questionnaire

    6-months

  • Cardiovascular fitness test

    6-months

  • Fasting glucose levels test

    6-months

  • Lipid level test

    6-months

  • Quality of life questionnaire (SF-36)

    6-months

  • +1 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Behavioral: Exercise

Attention Control Group

ACTIVE COMPARATOR

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

Interventions

ExerciseBEHAVIORAL

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.

Exercise Group
Attention ControlBEHAVIORAL

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

Attention Control Group

Eligibility Criteria

Age40 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Office of Minority Health and Health Disparities Research

Washington D.C., District of Columbia, 20003, United States

Location

MeSH Terms

Conditions

Motor ActivityMetabolic SyndromeProstatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

March 5, 2015

Study Start

July 1, 2013

Primary Completion

February 16, 2017

Study Completion

February 16, 2017

Last Updated

February 23, 2017

Record last verified: 2014-09

Locations

US(1)