Health Promotion for Women With Fibromyalgia
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Austin、Texas、アメリカ、78701
- The University of Texas at Austin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
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プラセボコンパレーター：Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
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8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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SF36 Subscales
時間枠：Baseline, 2 months, 5 months and 8 months
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Baseline, 2 months, 5 months and 8 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Fibromyalgia Impact Questionnaire
時間枠：Baseline, 2 months, 5 months, 8 months
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Baseline, 2 months, 5 months, 8 months
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Health Behaviors - The Health Promoting Lifestyle Questionnaire
時間枠：Baseline, 2 months, 5 months 8 months
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Baseline, 2 months, 5 months 8 months
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協力者と研究者
捜査官
- 主任研究者：Alexa Stuifbergen, PhD, RN、The University of Texas at Austin School of Nursing
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Lifestyle Countsの臨床試験
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Oxford Biomedical Technologies, Inc.募集
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Universiti Sultan Zainal Abidin募集