- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577549
Weight Loss and Exercise for Communities With Arthritis in North Carolina (WE-CAN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non-pharmacologic treatment to reduce pain. Recently, the investigators determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to the investigators previous longterm weight loss and exercise trials of knee OA, the diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether the investigators results can be generalized to less rigorously monitored patient cohorts is unknown. Thus the challenge the investigators now face is to provide the practical means to implement this proven treatment in the community setting. This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.
Participants will be 820 ambulatory, community-dwelling, overweight and obese men and women who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a pragmatic, community-based 18-month diet-induced weight loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility. The investigators will also establish the cost-effectiveness of this pragmatic, community-based, multimodal diet-induced weight-loss and exercise program by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.
Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments. This study is significant in that it will test the effectiveness of a long-awaited and much needed community-based program that will serve as a blueprint for clinicians and public health officials in both urban and rural communities to implement a weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese people with knee OA that can be sustained long-term and at a reasonable cost.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27516
- Johnston County - UNC Chapel Hill
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Waynesville, North Carolina, United States, 28721
- Haywood County - Haywood Regional Medical Center
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Winston-Salem, North Carolina, United States, 27109
- Forsyth County - Wake Forest University/Wake Forest University Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age ≥ 50
- Knee Pain plus American College of Rheumatology (ACR) Criteria for Knee Osteoarthritis
- BMI = 27 ≥ kg/m2
Exclusion Criteria:
- Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
- Not sufficiently overweight or obese, BMI < 27 kg/m2
- Not having knee pain
- Inability to finish 18-month study or unlikely to be compliant (Planning to leave area > 2 month during the next 18 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
- Age, age < 50
- Other conditions that may prohibit the effective delivery of the intervention (Unable to provide own transportation to exercise center; Unable to read or write)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Diet & Exercise
Participants will attend an exercise class 3 days/week for 18 months.
The exercise program will consist of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase.
Participant's will also attend individual and group diet sessions.
Each participant's minimum weight loss goal will be 10% of baseline body weight.
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Participants will attend exercise and diet classes.
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Active Comparator: Attention Control
The attention control intervention will cover an 18-month period.
There will be five total face to face group meetings over the 18 months, with one meeting each at months 1, 3, 6, 9, and 15; and during the other months (months 2-5, 7-11, 13-17) participants will receive a combination of informational packets, webinars, phone sessions, and/or emails based on continued monitoring of participant needs and delivered via their preferred mode of contact.
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Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Pain
Time Frame: 18 months
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To determine whether a pragmatic, community-based, 18-month diet-induced weight-loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain [as measured by the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale] in overweight and obese adults with knee Osteoarthritis (OA) compared to an attention-control group - test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4) - Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations - The WOMAC measures five items for pain (score range 0-20).
Measure Description: Range, 0 to 20 (0, no pain; 2 to 8, mild; >8 to 14, moderate; and >14 to 20, severe); between-group MCID = 1.6, calculated as half the SD.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Function
Time Frame: 18 months
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To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves WOMAC self-reported function in overweight and obese adults with knee OA compared to an attention control group - test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4) - Higher scores on the WOMAC indicate more pain, stiffness, and functional limitations.
The WOMAC function score is a total of seventeen items for function (total score range 0-68).
Measure Description: Range, 0 to 68 (0, no difficulty; 68, extreme).
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18 months
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Health Related Quality of Life (SF-36) Physical Subscale
Time Frame: 18 months
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To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves health-related quality of life as measured by the physical subscale of the SF-36 questionnaire in overweight and obese adults with knee OA compared to an attention control group - Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state - The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
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18 months
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Mobility (Six Minute Walk)
Time Frame: 18 months
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To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves 6-minute walk distance (an accepted measure of mobility) in overweight and obese adults with knee OA compared to an attention control group.
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18 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness
Time Frame: 18 months
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To establish the cost-effectiveness of this pragmatic, community-based, multimodal diet-induced weight-loss and exercise program by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.
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18 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leigh Callahan, PhD, University of North Carolina, Chapel Hill
- Principal Investigator: Stephen P Messier, PhD, Wake Forest University
Publications and helpful links
General Publications
- Messier SP, Callahan LF, Beavers DP, Queen K, Mihalko SL, Miller GD, Losina E, Katz JN, Loeser RF, Quandt SA, DeVita P, Hunter DJ, Lyles MF, Newman J, Hackney B, Jordan JM. Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 22;18(1):91. doi: 10.1186/s12891-017-1441-4.
- Messier SP, Beavers DP, Queen K, Mihalko SL, Miller GD, Losina E, Katz JN, Loeser RF, DeVita P, Hunter DJ, Newman JJ, Quandt SA, Lyles MF, Jordan JM, Callahan LF. Effect of Diet and Exercise on Knee Pain in Patients With Osteoarthritis and Overweight or Obesity: A Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2242-2251. doi: 10.1001/jama.2022.21893.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00033618.WE-CAN
- U01AR068658 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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