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Creating African-American Wellness Through Exercise

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ClinicalTrials.gov Identifier: NCT00867776
Recruitment Status : Terminated (We decided to alter the intervention.)
First Posted : March 24, 2009
Last Update Posted : November 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Depression Behavioral: AAHC Exercise Program Support Group

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health
Study Start Date : June 2009
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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:
  • Support group
  • Psychoeducation
  • Exercise support
  • Self-care

Outcome Measures

Primary Outcome Measures :
  1. 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) ]

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867776

United States, Oregon
African American Health Coalition
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Oregon Health and Science University
African American Health Coalition
Principal Investigator: Christina M Nicolaidis, MD,MPH Oregon Health and Science University
More Information

Responsible Party: Christina M. Nicolaidis, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00867776     History of Changes
Other Study ID Numbers: IRB00005105
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015

Keywords provided by Christina M. Nicolaidis, Oregon Health and Science University:
African Americans
Culturally tailored intervention
Health disparities

Additional relevant MeSH terms:
Behavioral Symptoms