Clinical trial NCT02728661: Patient-Centered Weight Loss Program for Knee Replacement Patients
Official title: Patient-Centered Weight Loss Program for Knee Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ARTHROPLASTY, REPLACEMENT
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2016-04-05
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* BMI between 25-45 kg/m2
* Have a scheduled knee replacement at least 1 week away from baseline assessment
* 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 simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee in the next 26 weeks
* 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.

Primary outcomes:
measure: Change in weight measured with a balance-beam scale
timeFrame: Change from baseline to 12 and 26 weeks
Secondary outcomes:
measure: Change in physical function assessed by the timed up and go
timeFrame: Change from baseline to 12 and 26 weeks
measure: Change in pain measured by WOMAC
timeFrame: Change from baseline to 12 and 26 weeks
Other outcomes:
measure: Change in physical activity objectively-measured with accelerometry
timeFrame: Change from baseline to 12 and 26 weeks
measure: Behavioral adherence assessed by session and self-monitoring completion
timeFrame: 26 weeks post-op
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: