Osteoarthritis
Conditions
Keywords
Knee Pain, Exercise, Diet, Weight Loss
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.
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.
Interventions
BEHAVIORALDiet & Exercise
Participants will attend exercise and diet classes.
BEHAVIORALAttention Control
Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function | 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 - 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). |
| Health Related Quality of Life (SF-36) Physical Subscale | 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 - 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. |
| Mobility (Six Minute Walk) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 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. |
Countries
United States
Participant flow
Recruitment details
We used overlapping recruitment strategies. A combination of mailings, local newspaper ads, and direct targeting through electronic health records were used. We also had strong ties with local aging service networks and access to senior centers, senior high-rise residential sites, churches, and a large database of older adults who signed consent to be contacted about participating in future clinical trials.
Participants by arm
| Arm | Count |
|---|---|
| Diet & Exercise Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted 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 also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight.
Diet & Exercise: Participants attended exercise and diet classes. | 414 |
| Attention Control The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month.
Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts. | 409 |
| Total | 823 |
Baseline characteristics
| Characteristic | Diet & Exercise | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 7.8 | 64.6 years STANDARD_DEVIATION 7.8 | 64.7 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 407 Participants | 808 Participants | 401 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 111 Participants | 227 Participants | 116 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 289 Participants | 570 Participants | 281 Participants |
| Sex: Female, Male Female | 320 Participants | 637 Participants | 317 Participants |
| Sex: Female, Male Male | 94 Participants | 186 Participants | 92 Participants |
| Womac pain score | 7.5 score on a scale STANDARD_DEVIATION 3.2 | 7.5 score on a scale STANDARD_DEVIATION 3.2 | 7.5 score on a scale STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 414 | 3 / 409 |
| other Total, other adverse events | 107 / 414 | 93 / 409 |
| serious Total, serious adverse events | 67 / 414 | 96 / 409 |
Outcome results
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.
Time frame: 18 months
Population: A total of 13 persons (7 in D\&E and 6 in attention control) did not complete this testing measure but completed other measures.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet & Exercise | Knee Pain | 5.0 score on a scale |
| Attention Control | Knee Pain | 5.5 score on a scale |
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).
Time frame: 18 months
Population: Not all persons completing the study completed this measure at follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet & Exercise | Function | 16.5 score on a scale |
| Attention Control | Function | 19.8 score on a scale |
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.
Time frame: 18 months
Population: Not all persons completing the study completed this measure at follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet & Exercise | Health Related Quality of Life (SF-36) Physical Subscale | 41.4 score on a scale |
| Attention Control | Health Related Quality of Life (SF-36) Physical Subscale | 37.6 score on a scale |
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.
Time frame: 18 months
Population: Not all persons completing the study completed this measure at follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet & Exercise | Mobility (Six Minute Walk) | 419 meters |
| Attention Control | Mobility (Six Minute Walk) | 376 meters |
Other Pre-specified
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.
Time frame: 18 months
Population: Currently only data for the primary outcome and some of the secondary outcomes have been analyzed and published. Additional analyses are being conducted. The cost effectiveness outcome measure will be available to report in the coming months.