NCT03107039

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

2.6 years

First QC Date

March 22, 2017

Last Update Submit

December 22, 2020

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • Depression symptoms

    The Quick Inventory of Depression Symptomatology will be used to assess depression.

    6 months

Secondary Outcomes (1)

  • Blood lipids

    6 months

Study Arms (2)

Exercise

EXPERIMENTAL

This arm will use a resistance exercise curriculum.

Behavioral: Exercise

Health Education

ACTIVE COMPARATOR

This arm will use health education curriculum.

Behavioral: Health Education

Interventions

ExerciseBEHAVIORAL

A 12 week resistance exercise curriculum

Exercise
Health EducationBEHAVIORAL

A 12 week health education curriculum

Health Education

Eligibility Criteria

Age21 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBlack or African American
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing depression symptoms and generally healthy.

You may not qualify if:

  • Anyone assessed to be unsafe to be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (2)

  • Ciccolo JT, Louie ME, SantaBarbara NJ, Webster CT, Whitworth JW, Nosrat S, Chrastek M, Dunsiger SI, Carey MP, Busch AM. Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy. BMC Psychiatry. 2022 Apr 21;22(1):283. doi: 10.1186/s12888-022-03935-x.

    PMID: 35448974DERIVED

  • Busch AM, Louie ME, SantaBarbara NJ, Ajayi AA, Gleason N, Dunsiger SI, Carey MP, Ciccolo JT. Effects of resistance training on depression and cardiovascular disease risk in Black men: Protocol for a randomized controlled trial. Ment Health Phys Act. 2019 Oct;17:100299. doi: 10.1016/j.mhpa.2019.100299. Epub 2019 Sep 12.

    PMID: 32863882DERIVED

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joseph Ciccolo, PhD

    Teachers College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2 group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 11, 2017

Study Start

September 1, 2016

Primary Completion

April 1, 2019

Study Completion

January 31, 2020

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)