Health Promotion for Women With Fibromyalgia

The University of Texas System (UT)

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Attention Control; Behavioral: Lifestyle Counts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00596674

R01HD035047 (U.S. NIH Grant/Contract)

2002-08-0043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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177 participants in 2 patient groups, including a placebo group

Lifestyle Counts Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Counts

Attention Countrol

Placebo Comparator group

Description:

8 weeks of general health classes followed by phone calls for 3 months

Treatment:

Other: Attention Control