- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60601
- Blue Cross Blue Shield of Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine Department of Preventive Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A worksite activity-diet intervention
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
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Ingen indgriben: Motiva Program
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
change in accelerometer counts/day
Tidsramme: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
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change in kilocalorie intake
Tidsramme: 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
Tidsramme: Baseline, 3, 6 and 12 months
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Baseline, 3, 6 and 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
20 meter walk
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R21AR062317 (U.S. NIH-bevilling/kontrakt)
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