OsteoarthritisWE-CANNCT02577549
Weight Loss and Exercise for Communities With Arthritis in North Carolina
A study testing Diet & Exercise in people with Osteoarthritis, run by Wake Forest University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diet & Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to 28 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 50
- Knee Pain plus American College of Rheumatology (ACR) Criteria for Knee Osteoarthritis
- BMI = 27 ≥ kg/m2
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johnston County - UNC Chapel Hill
Chapel Hill, North Carolina, 27516
Haywood County - Haywood Regional Medical Center
Waynesville, North Carolina, 28721
Forsyth County - Wake Forest University/Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Diet & Exercise, Attention Control
- Keywords
- Knee Pain, Exercise, Diet, Weight Loss
- Medical subject headings
- Osteoarthritis, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet & ExerciseBehavioural
Participants will attend exercise and diet classes.
Attention ControlBehavioural
Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.
| Study group | Role | What they receive |
|---|---|---|
| Diet & Exercise | Experimental | 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. Receives: Behavioral: Diet & Exercise |
| Attention Control | Active comparator | 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
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).
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Stephen P Messier, PhD, Principal investigator, Wake Forest UniversityLeigh Callahan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577549
- Sponsor's protocol ID
- IRB00033618.WE-CAN
- Other IDs
- U01AR068658
- Acronym
- WE-CAN
- Status last verified
- Jun 2021
- First submitted
- 12 Oct 2015
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28228115Messier 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.
PubMed 36511925Messier SP, Gill ME, Mihalko SL, Beavers DP, Queen K, Miller GD, Losina E, Katz JN, Loeser RF, DeVita P, Hunter DJ, Quandt SA, Lyles MF, Hudson D, Callahan LF. Clinical, Health-Related Quality of Life, and Gait Differences Among Obesity Classes in Adults With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2024 Apr;76(4):503-510. doi: 10.1002/acr.25265. Epub 2024 Jan 16.
PubMed 37885103
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Exercise for Communities With Arthritis in North Carolina
- ClinicalTrials.gov ID
- NCT02577549
- Acronym / sponsor ID
- WE-CAN / IRB00033618.WE-CAN
- Conditions
- Osteoarthritis
- Keywords
- Knee Pain, Exercise, Diet, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2016
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet & Exercise | Experimental | Behavioral: Diet & ExerciseParticipants 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. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 50
- Knee Pain plus American College of Rheumatology (ACR) Criteria for Knee Osteoarthritis
- BMI = 27 ≥ kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet & ExerciseParticipants will attend exercise and diet classes. | Behavioural | Diet & Exercise |
| Attention ControlParticipants will attend healthy living classes and receive health newsletters and phone calls/emails/texts. | Behavioural | Attention Control |
Primary outcome
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 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.
3 secondary outcomes
Function
Time frame: 18 months
Health Related Quality of Life (SF-36) Physical Subscale
Time frame: 18 months
Mobility (Six Minute Walk)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28228115Messier 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.
- Results publication: PubMed 36511925Messier 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.
- Derived from this study: PubMed 37885103Messier SP, Gill ME, Mihalko SL, Beavers DP, Queen K, Miller GD, Losina E, Katz JN, Loeser RF, DeVita P, Hunter DJ, Quandt SA, Lyles MF, Hudson D, Callahan LF. Clinical, Health-Related Quality of Life, and Gait Differences Among Obesity Classes in Adults With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2024 Apr;76(4):503-510. doi: 10.1002/acr.25265. Epub 2024 Jan 16.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Messier, PhD principal investigator
Wake Forest University
Leigh Callahan, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet & Exercise in people with Osteoarthritis, run by Wake Forest University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.