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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Lifestyle Counts; Other: Attention Control

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • The University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Lifestyle Counts; 8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
Placebo Comparator: Attention Countrol; 8 weeks of general health classes followed by phone calls for 3 months	Other: Attention Control; 8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SF36 Subscales	Baseline, 2 months, 5 months and 8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Fibromyalgia Impact Questionnaire	Baseline, 2 months, 5 months, 8 months
Health Behaviors - The Health Promoting Lifestyle Questionnaire	Baseline, 2 months, 5 months 8 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Alexa Stuifbergen, PhD, RN, The University of Texas at Austin School of Nursing

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (Estimate): January 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Quality of Life; Women; Fibromyalgia Syndrome; Health Behaviors
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2002-08-0043; R01HD035047 (U.S. NIH Grant/Contract)