JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
Primary Purpose
Chronic Knee Pain, Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A worksite activity-diet intervention
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Knee Pain focused on measuring Arthritis, Physical Activity, Diet
Eligibility Criteria
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
Sites / Locations
- Blue Cross Blue Shield of Illinois
- Northwestern University Feinberg School of Medicine Department of Preventive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A worksite activity-diet intervention
Motiva Program
Arm Description
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
Outcomes
Primary Outcome Measures
change in accelerometer counts/day
change in kilocalorie intake
percent change in body weight
Secondary Outcome Measures
20 meter walk
Change in walking velocity
chair stand test
Change in chair-stand rate
Full Information
NCT ID
NCT01977872
First Posted
October 31, 2013
Last Updated
December 29, 2014
Sponsor
Northwestern University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Blue Cross Blue Shield
1. Study Identification
Unique Protocol Identification Number
NCT01977872
Brief Title
JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
Official Title
JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Blue Cross Blue Shield
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Pain, Osteoarthritis, Knee
Keywords
Arthritis, Physical Activity, Diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A worksite activity-diet intervention
Arm Type
Experimental
Arm Description
A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.
Arm Title
Motiva Program
Arm Type
No Intervention
Arm Description
The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.
Intervention Type
Behavioral
Intervention Name(s)
A worksite activity-diet intervention
Primary Outcome Measure Information:
Title
change in accelerometer counts/day
Time Frame
Baseline, 3, 6 and 12 months
Title
change in kilocalorie intake
Time Frame
Baseline, 3, 6 and 12 months
Title
percent change in body weight
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
20 meter walk
Description
Change in walking velocity
Time Frame
Baseline, 3, 6 and 12 months
Title
chair stand test
Description
Change in chair-stand rate
Time Frame
Baseline, 3, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Blue Cross Blue Shield of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine Department of Preventive Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
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