Health Promotion for Women With Fibromyalgia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Health Promotion for Women With Fibromyalgia|
- SF36 Subscales [ Time Frame: Baseline, 2 months, 5 months and 8 months ] [ Designated as safety issue: No ]
- Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 2 months, 5 months, 8 months ] [ Designated as safety issue: No ]
- Health Behaviors - The Health Promoting Lifestyle Questionnaire [ Time Frame: Baseline, 2 months, 5 months 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: Lifestyle Counts Intervention
A wellness intervention that includes 8 weeks of behavior change classes focused on acquiring the skills and knowledge to improve health behaviors (e.g., exercise, stress management), followed by 3 months of phone support.
Behavioral: Lifestyle Counts
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
Placebo Comparator: Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
Other: Attention Control
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596674
|United States, Texas|
|The University of Texas at Austin|
|Austin, Texas, United States, 78701|
|Principal Investigator:||Alexa Stuifbergen, PhD, RN||The University of Texas at Austin School of Nursing|