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- Klinische proef NCT01977872
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60601
- Blue Cross Blue Shield of Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University Feinberg School of Medicine Department of Preventive Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: A worksite activity-diet intervention
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
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Geen tussenkomst: Motiva Program
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
change in accelerometer counts/day
Tijdsspanne: Baseline, 3, 6 and 12 months
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Baseline, 3, 6 and 12 months
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change in kilocalorie intake
Tijdsspanne: 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
Tijdsspanne: Baseline, 3, 6 and 12 months
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Baseline, 3, 6 and 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
20 meter walk
Tijdsspanne: 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
Tijdsspanne: Baseline, 3, 6 and 12 months
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Change in chair-stand rate
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Baseline, 3, 6 and 12 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Quality of Life
Tijdsspanne: Baseline, 3 months, 6 months, 12 months
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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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R21AR062317 (Subsidie/contract van de Amerikaanse NIH)
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