Creating African-American Wellness Through Exercise

This study has been suspended.
(Study suspended to evaluate feasibility data and potentially adapt intervention.)
Sponsor:
Collaborator:
African American Health Coalition
Information provided by (Responsible Party):
Christina M. Nicolaidis, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00867776
First received: March 23, 2009
Last updated: April 11, 2012
Last verified: April 2012

March 23, 2009
April 11, 2012
June 2009
May 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00867776 on ClinicalTrials.gov Archive Site
  • Frequency of exercise using the International Physical Activity questionnaire(IPAQ). [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
  • Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS). [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
  • Use of guideline-concordant depression therapies [ Time Frame: week 1 and week 6 ] [ Designated as safety issue: No ]
  • Acceptability of antidepressant therapy and counseling [ Time Frame: week 1 and week 6 ] [ Designated as safety issue: No ]
  • Depression self-care behaviors [ Time Frame: week 1 and week 6 ] [ Designated as safety issue: No ]
  • Satisfaction with program [ Time Frame: week 6 ] [ Designated as safety issue: No ]
  • Attendance to sessions [ Time Frame: Each week for 6 weeks ] [ Designated as safety issue: No ]
  • Depression care self-efficacy [ Time Frame: week 1 and week 6 ] [ Designated as safety issue: No ]
Same as current
 
 
 
Creating African-American Wellness Through Exercise
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.

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.

Interventional
 
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Depression
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
Experimental: 6 Week Support group
Intervention: Behavioral: AAHC Exercise Program Support Group
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00867776
IRB00005105
No
Christina M. Nicolaidis, Oregon Health and Science University
Oregon Health and Science University
African American Health Coalition
Principal Investigator: Christina M Nicolaidis, MD,MPH Oregon Health and Science University
Oregon Health and Science University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP