Creating African-American Wellness Through Exercise

October 30, 2015 updated by: Christina M. Nicolaidis, Oregon Health and Science University

Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health

The purpose of this study is to pilot-test a culturally-tailored, community-based educational program for African-Americans, focusing on how to use exercise and other self-management strategies to reduce depressive symptoms and improve health. This study will explore what type of additional support would encourage depressed African-Americans to exercise regularly. The investigators hypothesize that participants will report greater frequency of exercise and lower depression scores at the end of the program than they did at baseline. However, this study is not adequately powered to test this hypothesis - the main goal is to assess feasibility, acceptability and satisfaction of the pilot intervention.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Several studies have documented the effectiveness of exercise as a treatment for depression. However, these studies have used supervised exercise in medical school or university environments and have included mostly middle-class White populations. Little is known regarding how to translate these findings to real world settings or to minority populations. Exercise may be a particularly beneficial option for African-Americans suffering from depression. African-Americans face significant disparities in depression care. At least a part of these disparities are due to lack of trust in the healthcare system and negative attitudes toward antidepressants. Our goal is to pilot-test a culturally-tailored, community-based exercise support program for depressed African-Americans. We will recruit participants who screened positive for moderate depressive symptoms when they enrolled in the African-American Health Coalition's Free Exercise Card Program, but who are exercising less than 3 times per week. They will participate in a 6-week educational self-care group focusing on how to use exercise and other self-help tools to reduce depressive symptoms. Participants will be encouraged to create action plans regarding exercise and other healthy lifestyle changes. Groups will also provide culturally-tailored information about depression therapies, such as antidepressants and psychotherapy, and discuss strategies for obtaining quality health care.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • African American Health Coalition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • African-American or of African-American descent
  • Currently participating in the African-American Health Coalition Free Exercise-Card Program
  • Experiencing moderate depressive symptoms, as indicated by a score of 10-20 on the Depression Scale of the Patient Health Questionnaire (PHQ-9.
  • Exercising less than three times per week (for a minimum of 30 minutes per session) over the past month

Exclusion Criteria:

  • Actively suicidal
  • If a health care provider, AAHC staff member, or an investigator feel that participation in the program may endanger the participant's health or safety.
  • Known mental or cognitive impairments
  • Known condition that precludes their ability to feasibly participate in a support group session.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AAHC Excercise Program Support Group
Participants taking part in the AAHC Exercise Program Support Group (the intervention).
Behavioral: AAHC Exercise Program Support Group
6-week community-based, culturally tailored support group program, focusing on exercise and healthy lifestyle habits. Groups will also include basic psychoeducation about depression and depression care. Groups will have up to 20 participants and will meet weekly for 2 hours. By the end of the program, participants will be encouraged to create a personalized action plan focusing on exercise and other healthy lifestyle choices.
Other Names:
  • Psychoeducation
  • Support group
  • Self-care
  • Exercise support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Time Frame: Week 1 (pre-test) and week 6 (post-test)
Week 1 (pre-test) and week 6 (post-test)

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of exercise using the International Physical Activity questionnaire(IPAQ).
Time Frame: Week 1 and Week 6
Week 1 and Week 6
Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).
Time Frame: Week 1 and Week 6
Week 1 and Week 6
Use of guideline-concordant depression therapies
Time Frame: week 1 and week 6
week 1 and week 6
Acceptability of antidepressant therapy and counseling
Time Frame: week 1 and week 6
week 1 and week 6
Depression self-care behaviors
Time Frame: week 1 and week 6
week 1 and week 6
Satisfaction with program
Time Frame: week 6
week 6
Attendance to sessions
Time Frame: Each week for 6 weeks
Each week for 6 weeks
Depression care self-efficacy
Time Frame: week 1 and week 6
week 1 and week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

African American Health Coalition

Investigators

  • Principal Investigator: Christina M Nicolaidis, MD,MPH, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00005105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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