Clinical trial NCT01977872: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Knee Pain
Osteoarthritis, Knee
Keywords: Arthritis
Physical Activity
Diet
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Blue Cross Blue Shield
First posted: 2013-11-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. assess the feasibility of conducting a randomized controlled trial of the JointADventure intervention at this worksite
2. estimate the effectiveness of the intervention to decrease body weight, improve dietary habits, and increase objectively-measured physical activity
3. to improve objectively measured functional performance
4. to improve self-reported arthritis-specific and generic health status and health utility

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

Primary outcomes:
measure: change in accelerometer counts/day
timeFrame: Baseline, 3, 6 and 12 months
measure: change in kilocalorie intake
timeFrame: Baseline, 3, 6 and 12 months
measure: percent change in body weight
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: 20 meter walk
timeFrame: Baseline, 3, 6 and 12 months
measure: chair stand test
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
measure: Quality of Life
timeFrame: Baseline, 3 months, 6 months, 12 months
Locations:
city: Chicago
country: United States
facility: Blue Cross Blue Shield of Illinois
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Department of Preventive Medicine
state: Illinois
Study officials:
References: