- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60601
- Blue Cross Blue Shield of Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine Department of Preventive Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A worksite activity-diet intervention
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
|
|
No Intervention: Motiva Program
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in accelerometer counts/day
Time Frame: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
change in kilocalorie intake
Time Frame: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
percent change in body weight
Time Frame: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
20 meter walk
Time Frame: Baseline, 3, 6 and 12 months
|
Change in walking velocity
|
Baseline, 3, 6 and 12 months
|
chair stand test
Time Frame: Baseline, 3, 6 and 12 months
|
Change in chair-stand rate
|
Baseline, 3, 6 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 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
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AR062317 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
Thammasat UniversityCompletedPrimary Knee OsteoarthritisThailand
-
Galderma R&DCompletedUnilateral Knee OsteoarthritisUnited Kingdom
-
National Yang Ming UniversityFar Eastern Memorial HospitalCompletedMedial Knee OsteoarthritisTaiwan
-
Hanlim Pharm. Co., Ltd.CompletedKnee OsteoarthritisKorea, Republic of
Clinical Trials on A worksite activity-diet intervention
-
Institut Català d'OncologiaUnknownRecurrence | Breast NeoplasmsSpain
-
Universidade Metodista de PiracicabaCompleted
-
Charite University, Berlin, GermanyCompleted
-
The University of Texas Health Science Center,...CompletedObesity | Physical Activity | Stress | DietUnited States
-
Ankara UniversityCompleted
-
University of Alabama at BirminghamCompletedBreast Cancer | Ductal Carcinoma In SituUnited States
-
Instituto Mexicano del Seguro SocialUniversity of California, Los Angeles; National Council of Science and Technology...CompletedCardiovascular Risk FactorsMexico
-
University College of AntwerpUnknownObesity | OverweightBelgium
-
Centre for Addiction and Mental HealthPublic Health Agency of Canada (PHAC); Medical Psychiatry AllianceCompletedSmoking Cessation | Physical Activity | Fruits and Vegetable ConsumptionCanada
-
University of OsloThe Research Council of Norway; European CommissionCompletedMetabolic Syndrome | Type 2 DiabetesNorway