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

December 29, 2014 updated by: Rowland W. Chang, Northwestern University

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

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

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.

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