NCT02728661

Patient-Centered Weight Loss Program for Knee Replacement Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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).

Conditions

• ARTHROPLASTY, REPLACEMENT

Interventions

Type	Name	Description
BEHAVIORAL	PACE	PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.
BEHAVIORAL	Delayed PACE	Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-04-05
• Last updated: 2023-10-26

Locations

1 site across 1 country: United States