JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized controlled trial evaluation of a physical activity and nutritional worksite intervention to decrease symptoms and disability associated with knee osteoarthritis (OA), a major public health problem and a leading cause of work disability and work absenteeism/presenteeism in the US workforce.
The overarching goal of this project is to find an effective and sustainable intervention strategy that can assist large populations of persons with or at risk for knee OA to attain and maintain healthy dietary and physical activity behaviors. This project has to potential to have a tremendous impact on improving symptoms and quality of life of persons with chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.
調査の概要
詳細な説明
We will utilize a partnership with Blue Cross Blue Shield of Illinois (BCBSIL), a highly supportive wellness partner, with a strong history of investment in the health of its employees and subscribers. The combined Activity/Dietary (AD) intervention is administered by health professionals trained in motivational interviewing as healthy lifestyle coaches.
Over the first 6 months, the coaches provide:
- individualized counseling based on a comprehensive assessment of baseline clinical, functional and behavioral factors that are barriers to healthy physical activity and dietary behaviors
- group education, the content of which is modeled after the highly successful Diabetes Prevention Program physical activity/dietary intervention, and customized for those with knee symptoms.
Follow-up assessments continue for 6 additional months.
Specific aims are to:
- assess the feasibility of conducting a randomized controlled trial of the JointADventure intervention at this worksite
- estimate the effectiveness of the intervention to decrease body weight, improve dietary habits, and increase objectively-measured physical activity
- to improve objectively measured functional performance
- to improve self-reported arthritis-specific and generic health status and health utility
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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-
Illinois
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Chicago、Illinois、アメリカ、60601
- Blue Cross Blue Shield of Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University Feinberg School of Medicine Department of Preventive Medicine
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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:
- BCBSIL employee
- Must be able to ambulate household distances (50 ft)
- Must be able to read and speak English
- Pain, aching, stiffness in or around one or both knees on most days for at least one month during the past 12 months
- BMI of >25, but <40
Exclusion Criteria:
- Primary diagnosis of fibromyalgia
- Any co-morbidity that is more functionally limiting than the knee symptoms (e.g. spinal stenosis, peripheral vascular disease or residual effects of stroke)
- Comorbid condition (based on medication review) that contraindicates a physical activity or dietary intervention
- Total joint replacement surgery within 1 year or plans for total joint replacement in the next 12 months
- Plans to relocate away from the Chicago-land area in the next 12 months
- Being on a special diet that is inconsistent with the DASH diet
- Concurrent involvement in a weight loss program
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：防止
- 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 |
|---|---|
|
実験的：A worksite activity-diet intervention
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
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|
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介入なし：Motiva Program
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
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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 |
|---|---|
|
change in accelerometer counts/day
時間枠：Baseline, 3, 6 and 12 months
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Baseline, 3, 6 and 12 months
|
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change in kilocalorie intake
時間枠：Baseline, 3, 6 and 12 months
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Baseline, 3, 6 and 12 months
|
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percent change in body weight
時間枠：Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
20 meter walk
時間枠：Baseline, 3, 6 and 12 months
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Change in walking velocity
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Baseline, 3, 6 and 12 months
|
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chair stand test
時間枠：Baseline, 3, 6 and 12 months
|
Change in chair-stand rate
|
Baseline, 3, 6 and 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life
時間枠：Baseline, 3 months, 6 months, 12 months
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)pain and function scores, Patient-Reported Objective Measurement Information System (PROMIS)scores, and change in Short Form 6D (SF-6D) utility scores
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Baseline, 3 months, 6 months, 12 months
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協力者と研究者
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。