Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Sponsor
Teachers College, Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT03107039
Collaborator
(none)
50
1
2
41
1.2
Study Details
Study Description
Brief Summary
This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
50 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
2 group2 group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Actual Study Start Date
:
Sep 1, 2016
Actual Primary Completion Date
:
Apr 1, 2019
Actual Study Completion Date
:
Jan 31, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise This arm will use a resistance exercise curriculum. |
Behavioral: Exercise
A 12 week resistance exercise curriculum
|
| Active Comparator: Health Education This arm will use health education curriculum. |
Behavioral: Health Education
A 12 week health education curriculum
|
Outcome Measures
Primary Outcome Measures
- Depression symptoms [6 months]
The Quick Inventory of Depression Symptomatology will be used to assess depression.
Secondary Outcome Measures
- Blood lipids [6 months]
Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Experiencing depression symptoms and generally healthy.
Exclusion Criteria:
- Anyone assessed to be unsafe to be enrolled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Teachers College, Columbia University | New York | New York | United States | 10027 |
Sponsors and Collaborators
- Teachers College, Columbia University
Investigators
- Principal Investigator: Joseph Ciccolo, PhD, Teachers College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Teachers College, Columbia University
ClinicalTrials.gov Identifier:
NCT03107039
Other Study ID Numbers:
- 512156
First Posted:
Apr 11, 2017
Last Update Posted:
Dec 23, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: