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Health Promotion for Women With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT00596674
First received: January 8, 2008
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Fibromyalgia
 Behavioral: Lifestyle Counts
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Health Promotion for Women With Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • SF36 Subscales [ Time Frame: Baseline, 2 months, 5 months and 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 2 months, 5 months, 8 months ] [ Designated as safety issue: No ]
  • Health Behaviors - The Health Promoting Lifestyle Questionnaire [ Time Frame: Baseline, 2 months, 5 months 8 months ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: July 2003
Study Completion Date: May 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596674

Locations
United States, Texas
The University of Texas at Austin
Austin, Texas, United States, 78701
Sponsors and Collaborators
University of Texas at Austin
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
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT00596674     History of Changes
Other Study ID Numbers: 2002-08-0043, R01HD035047
Study First Received: January 8, 2008
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Women
Fibromyalgia Syndrome
Health Behaviors
Quality of Life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013