Weight Loss and Exercise for Communities With Arthritis in North Carolina (WE-CAN)
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| ClinicalTrials.gov Identifier: NCT02577549 |
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Recruitment Status :
Recruiting
First Posted : October 16, 2015
Last Update Posted : July 16, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Behavioral: Diet & Exercise Behavioral: Attention Control | Not Applicable |
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 obesemen 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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 820 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 |
| 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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Behavioral: Diet & Exercise
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 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.
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Behavioral: Attention Control
Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts. |
- Knee pain in overweight and obese adults with knee Osteoarthritis compared to an attention-control group measured by WOMAC Pain Scale. [ Time Frame: 18 months ]
- Knee function in overweight and obese adults with knee Osteoarthritis compared to an attention-control group measured by WOMAC Function Scale. [ Time Frame: 18 months ]
- Health Related Quality of Life in overweight and obese adults with knee Osteoarthritis compared to an attention-control group measured by SF-36. [ Time Frame: 18 months ]
- Mobility in overweight and obese adults with knee Osteoarthritis compared to an attention-control group measured by six minute walk. [ Time Frame: 18 months ]
- Measurement of the cost-effectiveness of the implemented strategies for the diet/exercise intervention and budget impact analysis. [ Time Frame: 18 months ]The cost-effectiveness ratio provides a measure of value for money. The cost-effectiveness is measured in dollars per quality-adjusted life-year gained ($/QALY). The budget impact analysis will quantify the financial consequences of adopting the program by various payer models, including insurance organizations, healthcare systems, and government, given real-life resource constraints
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
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
| Contact: Jovita Newman, MA | 3367583969 | jollajk@wfu.edu |
| United States, North Carolina | |
| Johnston County - UNC Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27516 | |
| Contact: Betsy Hackney 919-966-0574 bshackne@email.unc.edu | |
| Principal Investigator: Joanne M Jordan, MD, MPH | |
| Principal Investigator: Leigh Callahan, PhD | |
| Sub-Investigator: Richard Loeser, MD | |
| Haywood County - Haywood Regional Medical Center | Recruiting |
| Waynesville, North Carolina, United States, 28721 | |
| Contact: Kate Queen, MD 828-558-0208 katequeen.queen@gmail.com | |
| Principal Investigator: Kate Queen, MD | |
| Forsyth County - Wake Forest University/Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27109 | |
| Contact: Jovita J Newman, MA 336-758-3969 jollajk@wfu.edu | |
| Principal Investigator: Stephen P. Messier, PhD | |
| Sub-Investigator: Shannon Mihalko, PhD | |
| Sub-Investigator: Gary Miller, RD, PhD | |
| Principal Investigator: Daniel Beavers, PhD | |
| Sub-Investigator: Mary Lyles, MD | |
| Sub-Investigator: Sara Quandt, PhD | |
| Sub-Investigator: Paul DeVita, PhD | |
| Principal Investigator: Elena Losina, PhD | |
| Sub-Investigator: Jeff Katz, MD | |
| Principal Investigator: | Stephen P Messier, PhD | Wake Forest University | |
| Principal Investigator: | Leigh Callahan, PhD | University of North Carolina, Chapel Hill |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT02577549 History of Changes |
| Other Study ID Numbers: |
IRB00033618 U01AR068658 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 16, 2015 Key Record Dates |
| Last Update Posted: | July 16, 2018 |
| Last Verified: | July 2018 |
| 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 ):
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Knee Pain Exercise Diet Weight Loss |
Additional relevant MeSH terms:
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Osteoarthritis Weight Loss Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Body Weight Changes Body Weight Signs and Symptoms |