Weight Loss and Exercise for Communities With Arthritis in North Carolina

Osteoarthritis Clinical Trial

— WE-CAN  

Official title:

Weight Loss and Exercise for Communities With Arthritis in North Carolina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577549
• Other study ID #: IRB00033618.WE-CAN
• Secondary ID: U01AR068658
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 28, 2021

Study information

• Verified date: June 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Weight Loss

Intervention

Behavioral:
• Diet & Exercise
Participants will attend exercise and diet classes.
• Attention Control
Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.

Locations

Country	Name	City	State
United States	Johnston County - UNC Chapel Hill	Chapel Hill	North Carolina
United States	Haywood County - Haywood Regional Medical Center	Waynesville	North Carolina
United States	Forsyth County - Wake Forest University/Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 O — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	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.	18 months
Primary	Knee Pain	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.	18 months
Secondary	Function	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).	18 months
Secondary	Health Related Quality of Life (SF-36) Physical Subscale	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.	18 months
Secondary	Mobility (Six Minute Walk)	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.	18 months