Health Promotion for Women With Fibromyalgia

NCT ID: NCT00596674

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2008-05-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Counts

Intervention Type: BEHAVIORAL

8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support

Attention Countrol

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

Group Type: PLACEBO_COMPARATOR

Attention Control

Intervention Type: OTHER

8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions

Interventions

Lifestyle Counts

8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support

Intervention Type: BEHAVIORAL

Attention Control

8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexa Stuifbergen, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin School of Nursing

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

R01HD035047

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2002-08-0043

Identifier Type: -

Identifier Source: org_study_id