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OpenTrials
Completed

NCT Number: NCT00596674

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.

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Key information

Conditions

Fibromyalgia Behavior Health Behavior Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counts

Behavioral

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

Attention Control

Other

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

Primary outcomes

  1. SF36 Subscales

    Time frame: Baseline, 2 months, 5 months and 8 months

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: Baseline, 2 months, 5 months, 8 months

  2. Health Behaviors - The Health Promoting Lifestyle Questionnaire

    Time frame: Baseline, 2 months, 5 months 8 months

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

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

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jan 17, 2008
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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