Fibromyalgia Clinical Trial
Official title:
Health Promotion for Women With Fibromyalgia
Verified date | April 2012 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.
Status | Completed |
Enrollment | 177 |
Est. completion date | May 2008 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Female - Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75, - Able to speak and read English - Willing to participate in 8-month intervention study Exclusion Criteria: - Pregnancy - Male - Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SF36 Subscales | Baseline, 2 months, 5 months and 8 months | No | |
Secondary | Fibromyalgia Impact Questionnaire | Baseline, 2 months, 5 months, 8 months | No | |
Secondary | Health Behaviors - The Health Promoting Lifestyle Questionnaire | Baseline, 2 months, 5 months 8 months | No |
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