Patient-Centered Weight Loss Program for Knee Replacement Patients
Condition: ARTHROPLASTY, REPLACEMENT
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PACE is a patient-centered weight loss program that was developed specifically for knee
      replacements based on input from stakeholders, including knee replacement patients, physical
      therapists, and orthopedic surgeons. In this pilot study, participants undergoing knee
      replacement will be randomized to either start a weight loss program before surgery (PACE) or
      after surgery (Delayed PACE). Both programs will receive a 14-week intervention and complete
      assessments at baseline (up to 6 weeks prior to surgery), 12 weeks after surgery, and 26
      weeks after surgery.
    

Detailed description: 
      It is estimated that half of patients diagnosed with knee osteoarthritis (OA) will need a
      total knee replacement (TKR) during their lifetime. Of patients who need a TKR, 80-95% are
      overweight or obese. While patients are encouraged to lose weight, limited, if any, guidance
      is provided to achieve recommended weight loss. Many patients perceive that TKR is a
      necessary precursor for the initiation of weight loss. Yet, 66% of patients actually gain
      weight by 2 years after surgery. Patients undergoing TKR not only face unique barriers (i.e.,
      pain, mobility limitations, motivation) to weight loss, but also have to balance pre- and
      post-operative concerns from physicians, surgeons, and rehabilitation specialists. To best
      accommodate the needs of both patients (pre- and post-TKR) and healthcare professionals
      (i.e., surgeon, physical therapist), patient and stakeholder engagement and activation is
      imperative in the development of a patient-centered weight loss intervention. Investigators
      completed 20 interviews with patients pre- and post-TKR and identified weight loss barriers,
      preferred intervention components (e.g., delivery method, contact frequency, self-monitoring
      modality) and patient-reported outcomes (e.g., physical function, pain) viewed as critical by
      patients. Investigators developed a patient-centered weight loss program (PACE) guided by
      these results and additional input from stakeholders to meet the needs of patients and
      healthcare professionals. PACE is a randomized pilot study comparing weight loss and
      patient-reported outcomes between PACE (program starting up to 6 weeks pre-TKR to 12 weeks
      post-TKR) and Delayed PACE (program starting 12 weeks post-TKR to 26 weeks post-TKR).
    

Intervention name(s): PACE; Delayed PACE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.; Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment