Health Promotion for Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Health Promotion for Women With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596674
• Other study ID #: 2002-08-0043
• Secondary ID: R01HD035047
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: April 24, 2012
• Start date: July 2003
• Est. completion date: May 2008

Study information

• 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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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