Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
Osteoarthritis (OA) occurs when the cartilage between two bones becomes worn down, and the
 bones begin to rub against each other in the joint. This often leads to pain, swelling,
 decreased joint motion, and the formation of bone spurs (tiny growths of new bone). Being
 overweight increases the risk of developing OA and fastens disease progression. This study
 will evaluate two different programs, lifestyle behavioral weight management and pain-coping
 skills training, in reducing the effects of knee OA in obese individuals.
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