Clinical trial NCT00596674: Health Promotion for Women With Fibromyalgia
Official title: Health Promotion for Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Women
Fibromyalgia Syndrome
Health Behaviors
Quality of Life
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-01-17
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: SF36 Subscales
timeFrame: Baseline, 2 months, 5 months and 8 months
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: Baseline, 2 months, 5 months, 8 months
measure: Health Behaviors - The Health Promoting Lifestyle Questionnaire
timeFrame: Baseline, 2 months, 5 months 8 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin School of Nursing
name: Alexa Stuifbergen, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: