Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lifestyle Behavioral Weight Management Program; Pain-Coping Skills Training; Standard Care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The lifestyle behavioral weight management program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.; The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.; Standard care will include routine medical care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment