We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified July 2016 by Stephen P. Messier, Ph.D., Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02577549
First Posted: October 16, 2015
Last Update Posted: January 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Stephen P. Messier, Ph.D., Wake Forest University Health Sciences
  Purpose
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 Intervention
Osteoarthritis Behavioral: Diet & Exercise Behavioral: Attention Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stephen P. Messier, Ph.D., Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 820
Study Start Date: January 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Information from the National Library of Medicine

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, Senior)
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)
  Contacts and Locations
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


Contacts
Contact: Jovita Newman, MA 3367583969 jollajk@wfu.edu

Locations
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         
Sponsors and Collaborators
Wake Forest University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Stephen P Messier, PhD Wake Forest University
Principal Investigator: Leigh Callahan, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Stephen P. Messier, Ph.D., Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02577549     History of Changes
Other Study ID Numbers: 1U01AR068658-01 ( U.S. NIH Grant/Contract )
U01AR068658 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2015
First Posted: October 16, 2015
Last Update Posted: January 25, 2017
Last Verified: July 2016

Keywords provided by Stephen P. Messier, Ph.D., Wake Forest University Health Sciences:
Knee Pain
Exercise
Diet
Weight Loss

Additional relevant MeSH terms:
Osteoarthritis
Weight Loss
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms


To Top