JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain

Osteoarthritis, Knee Clinical Trial

Official title:

JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977872
• Other study ID #: R21AR062317
• Secondary ID: R21AR062317
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: December 29, 2014
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Knee Pain
• Osteoarthritis, Knee

Intervention

Behavioral:
• A worksite activity-diet intervention

Locations

Country	Name	City	State
United States	Blue Cross Blue Shield of Illinois	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine Department of Preventive Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Blue Cross Blue Shield, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	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	No
Primary	change in accelerometer counts/day		Baseline, 3, 6 and 12 months	No
Primary	change in kilocalorie intake		Baseline, 3, 6 and 12 months	No
Primary	percent change in body weight		Baseline, 3, 6 and 12 months	No
Secondary	20 meter walk	Change in walking velocity	Baseline, 3, 6 and 12 months	No
Secondary	chair stand test	Change in chair-stand rate	Baseline, 3, 6 and 12 months	No