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Weight Loss and Exercise for Communities With Arthritis in North Carolina (WE-CAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577549
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Diet & Exercise Behavioral: Attention Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 823 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight Loss and Exercise for Communities With Arthritis in North Carolina
Study Start Date : January 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Diet & Exercise
Participants will attend exercise and diet classes.

Active Comparator: Attention Control
The attention control intervention will cover an 18-month period. There will be four total face to face group meetings over the 18 months, with one meeting each at months 1, 6, 12, and 18; and during the other months (months 2-5, 7-11, 13-17) participants will receive a combination of informational packets, webinars, and/or emails based on continued monitoring of participant needs and delivered via their preferred mode of contact.
Behavioral: Attention Control
Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.




Primary Outcome Measures :
  1. Knee pain [ Time Frame: 18 months ]
    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 OA compared to an attention-control group.


Secondary Outcome Measures :
  1. Function [ Time Frame: 18 months ]
    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.

  2. Health Related Quality of Life (SF-36) [ Time Frame: 18 months ]
    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.

  3. Mobility (six minute walk) [ Time Frame: 18 months ]
    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.

  4. Cost-effectiveness [ Time Frame: 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ≥ 50
  • Knee Pain plus 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577549


Locations
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United States, North Carolina
Johnston County - UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Haywood County - Haywood Regional Medical Center
Waynesville, North Carolina, United States, 28721
Forsyth County - Wake Forest University/Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27109
Sponsors and Collaborators
Wake Forest University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Stephen P Messier, PhD Wake Forest University
Principal Investigator: Leigh Callahan, PhD University of North Carolina, Chapel Hill

Publications:
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT02577549    
Other Study ID Numbers: IRB00033618.WE-CAN
U01AR068658 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Knee Pain
Exercise
Diet
Weight Loss
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms