Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis

Osteoarthritis is a chronic, degenerative joint disorder that does not have a cure. While OA
can occur at almost any joint, it most commonly occurs in the knee. Obesity is a significant
risk factor for the development of knee OA and is associated with faster disease progression.
Biomechanical inflammation and cognitive behavioral changes related to obesity can exacerbate
OA pain and disability. The purpose of this study is to develop more effective ways to treat
individuals with knee OA. Specifically, the study will compare the effectiveness of a
lifestyle behavioral weight management program, pain-coping skills training, and standard
care in improving OA symptoms and day-to-day function in obese individuals with OA in one or
both knees.

The study treatment groups will meet for a total of 6 months. Participants will be randomly
assigned to one of four conditions: 1) lifestyle behavioral weight management program, 2)
pain-coping skills training, 3) lifestyle behavioral weight management program plus
pain-coping skills training, or 4) standard care. The lifestyle behavioral weight management
program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. The
pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing
adaptive strategies to control and decrease pain. Standard care will include routine medical
care.

Participants in the first three conditions will attend 12 weekly group sessions, followed by
6 every-other-week group sessions. After completing treatment, participants will receive
monthly follow-up telephone calls to facilitate the post-treatment transition. There will be
a total of four evaluations during this study: immediately prior to treatment, immediately
after treatment, and 6 and 12 months following the end of treatment. During each evaluation,
blood and urine will be collected to analyze disease biomarkers. An exercise treadmill test
and height, weight, and body mass index measures will be used to assess aerobic fitness.
Lower extremity function will be measured with the "Up and Go" performance test. Participants
will also be videotaped while walking to evaluate gait and will be asked to fill out a series
of questionnaires. Medication use will be reviewed during an interview. During the first
evaluation, x-rays will be taken to measure disease activity.

Participants completing the study intervention and all four follow-up evaluations will be
eligible to join the second part of the study examining the relationship between food intake,
mood, activity level, and pain. Participants will complete a series of questionnaires at
baseline and 2-day diaries in which they rate mood, pain, and activity level and they record
food intake triggered at random times throughout the day. A follow-up visit to complete
additional questionnaires will be conducted 6 months later. Blood samples will also be
collected for future analysis of genetic markers of pain sensitivity.

Inclusion Criteria:

- Meets the American College of Rheumatology criteria for OA

- Radiographic evidence of OA affecting one or both knees

- Complaints of chronic knee pain (pain on most days for at least 6 months prior to
study entry)

- No other major weight-bearing joint affected by OA

Exclusion Criteria:

- Any significant medical condition or disease that would make study participation
unsafe or increase the risk of a significant adverse experience during the course of
the study (e.g., myocardial infarction in the 6 months prior to study entry)

- Currently involved in a regular exercise program

- An abnormal cardiac response to exercise, such as exercise-induced BT or an abnormal
blood pressure response

- A body mass index (BMI) greater than 42

- A non-OA inflammatory arthropathy

- Currently using oral corticosteroids on a regular basis

- Anticipate to have a knee surgery in the next 18 months (or before the anticipated
date of their study completion)

- Knee surgery (arthroscopic or knee replacement) within a year of enrollment

- Intraarticular steroid or hyaluronan knee injections in one of both knees within 3
months of enrollment