Weight Loss and Exercise for Communities With Arthritis in North Carolina

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.

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)