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Completed

NCT Number: 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.

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Key information

Conditions

Chronic Knee Pain Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blue Cross Blue Shield of Illinois, Chicago, Illinois, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A worksite activity-diet intervention

Behavioral

Primary outcomes

  1. change in accelerometer counts/day

    Time frame: Baseline, 3, 6 and 12 months

  2. change in kilocalorie intake

    Time frame: Baseline, 3, 6 and 12 months

  3. percent change in body weight

    Time frame: Baseline, 3, 6 and 12 months

Secondary outcomes

  1. 20 meter walk

    Time frame: Baseline, 3, 6 and 12 months

    Change in walking velocity

  2. chair stand test

    Time frame: Baseline, 3, 6 and 12 months

    Change in chair-stand rate

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Blue Cross Blue Shield
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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