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

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT01977872
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), Blue Cross Blue Shield (Other)
38
2
2
24
19
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A worksite activity-diet intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: A worksite activity-diet intervention

A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.

Behavioral: A worksite activity-diet intervention

No Intervention: Motiva Program

The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.

Outcome Measures

Primary Outcome Measures

  1. change in accelerometer counts/day [Baseline, 3, 6 and 12 months]

  2. change in kilocalorie intake [Baseline, 3, 6 and 12 months]

  3. percent change in body weight [Baseline, 3, 6 and 12 months]

Secondary Outcome Measures

  1. 20 meter walk [Baseline, 3, 6 and 12 months]

    Change in walking velocity

  2. chair stand test [Baseline, 3, 6 and 12 months]

    Change in chair-stand rate

Other Outcome Measures

  1. Quality of Life [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blue Cross Blue Shield of Illinois Chicago Illinois United States 60601
2 Northwestern University Feinberg School of Medicine Department of Preventive Medicine Chicago Illinois United States 60611

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rowland W. Chang, Professor of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University
ClinicalTrials.gov Identifier:
NCT01977872
Other Study ID Numbers:
  • R21AR062317
  • R21AR062317
First Posted:
Nov 7, 2013
Last Update Posted:
Dec 30, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Rowland W. Chang, Professor of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2014