Patient-Centered Weight Loss Program for Knee Replacement Patients



Status:Recruiting
Healthy:No
Age Range:40 - 79
Updated:5/28/2016
Start Date:May 2016
End Date:July 2017
Contact:Christine A Pellegrini, PhD
Email:c-pellegrini@northwestern.edu
Phone:3125031395

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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 an 18-week intervention and
complete assessments at baseline (6 weeks prior to surgery), 12 weeks after surgery, and 30
weeks after surgery.

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 6 weeks pre-TKR to 12 weeks
post-TKR) and Delayed PACE (program starting 12 weeks post-TKR to 30 weeks post-TKR).

Inclusion Criteria:

- BMI between 25-39.9 kg/m2

- Have a scheduled primary TKR within the next 6-12 weeks

- Obtain physician approval to participate

- English speaking

- willing to attend 3 in-person assessments.

Exclusion Criteria:

- Have any contraindications to diet or weight loss

- Undergoing bilateral knee replacement or have a scheduled or anticipated knee
replacement for the contralateral knee

- Have a mobility limiting comorbidity besides relating to TKR

- Taking anti-obesity medications

- Enrolled in a formal weight loss program

- Have had or is planning to have bariatric/gastric/lapband surgery

- Is planning to relocate out of the Chicago land area in the next 12 months.
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-1395
?
mi
from
Chicago, IL
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