Health Promotion for Women With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596674
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : April 25, 2012
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Texas at Austin

January 8, 2008
January 17, 2008
April 25, 2012
July 2003
January 2007   (Final data collection date for primary outcome measure)
SF36 Subscales [ Time Frame: Baseline, 2 months, 5 months and 8 months ]
Same as current
Complete list of historical versions of study NCT00596674 on Archive Site
  • Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 2 months, 5 months, 8 months ]
  • Health Behaviors - The Health Promoting Lifestyle Questionnaire [ Time Frame: Baseline, 2 months, 5 months 8 months ]
Same as current
Not Provided
Not Provided
Health Promotion for Women With Fibromyalgia
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Behavioral: Lifestyle Counts
    8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
  • Other: Attention Control
    8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
  • 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.
    Intervention: Behavioral: Lifestyle Counts
  • Placebo Comparator: Attention Countrol
    8 weeks of general health classes followed by phone calls for 3 months
    Intervention: Other: Attention Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2008
January 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01HD035047 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Texas at Austin
University of Texas at Austin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Alexa Stuifbergen, PhD, RN The University of Texas at Austin School of Nursing
University of Texas at Austin
April 2012

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