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Patient-Centered Weight Loss Program for Knee Replacement Patients (PACE)

Primary Purpose

ARTHROPLASTY, REPLACEMENT

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PACE
Delayed PACE
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARTHROPLASTY, REPLACEMENT

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PACE

Delayed PACE

Arm Description

PACE participants will begin up to 6 weeks prior to their scheduled TKR and continue until 12 weeks after their TKR. Participants will be given personalized weight, dietary, and physical activity goals. Participants will be encouraged to monitor their dietary intake and physical activity using their preferred method of self-monitoring. Participants will have regular contact with their coaches either in-person or over the telephone on a weekly or bi-weekly basis, based on preference during the first 14 weeks (from up to 6 weeks pre-op to 12 weeks post-op). Further, participants may opt to receive regular text messages or emails from coaches if they prefer. At 12 weeks, PACE participants will enter a maintenance period and not have any contact with coaches.

After being notified of their randomized condition at baseline (up to 6 weeks prior to surgery), Delayed PACE participants will not have contact with coaches until 12 weeks after surgery. At 12 weeks after surgery, Delayed PACE participants will be given personalized weight, dietary, and physical activity goals. Participants will be encouraged to monitor their dietary intake and physical activity using their preferred method of self-monitoring. Participants will have regular contact with their coaches either in-person or over the telephone on a weekly or bi-weekly basis, based on preference during the first 14 weeks. Further, participants may opt to receive regular text messages or emails from coaches if they prefer.

Outcomes

Primary Outcome Measures

Change in weight measured with a balance-beam scale

Secondary Outcome Measures

Change in physical function assessed by the timed up and go
Change in pain measured by WOMAC

Full Information

First Posted
March 29, 2016
Last Updated
September 1, 2017
Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT02728661
Brief Title
Patient-Centered Weight Loss Program for Knee Replacement Patients
Acronym
PACE
Official Title
Patient-Centered Weight Loss Program for Knee Replacement Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARTHROPLASTY, REPLACEMENT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACE
Arm Type
Experimental
Arm Description
PACE participants will begin up to 6 weeks prior to their scheduled TKR and continue until 12 weeks after their TKR. Participants will be given personalized weight, dietary, and physical activity goals. Participants will be encouraged to monitor their dietary intake and physical activity using their preferred method of self-monitoring. Participants will have regular contact with their coaches either in-person or over the telephone on a weekly or bi-weekly basis, based on preference during the first 14 weeks (from up to 6 weeks pre-op to 12 weeks post-op). Further, participants may opt to receive regular text messages or emails from coaches if they prefer. At 12 weeks, PACE participants will enter a maintenance period and not have any contact with coaches.
Arm Title
Delayed PACE
Arm Type
Experimental
Arm Description
After being notified of their randomized condition at baseline (up to 6 weeks prior to surgery), Delayed PACE participants will not have contact with coaches until 12 weeks after surgery. At 12 weeks after surgery, Delayed PACE participants will be given personalized weight, dietary, and physical activity goals. Participants will be encouraged to monitor their dietary intake and physical activity using their preferred method of self-monitoring. Participants will have regular contact with their coaches either in-person or over the telephone on a weekly or bi-weekly basis, based on preference during the first 14 weeks. Further, participants may opt to receive regular text messages or emails from coaches if they prefer.
Intervention Type
Behavioral
Intervention Name(s)
PACE
Intervention Description
PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.
Intervention Type
Behavioral
Intervention Name(s)
Delayed PACE
Intervention Description
Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.
Primary Outcome Measure Information:
Title
Change in weight measured with a balance-beam scale
Time Frame
Change from baseline to 12 and 26 weeks
Secondary Outcome Measure Information:
Title
Change in physical function assessed by the timed up and go
Time Frame
Change from baseline to 12 and 26 weeks
Title
Change in pain measured by WOMAC
Time Frame
Change from baseline to 12 and 26 weeks
Other Pre-specified Outcome Measures:
Title
Change in physical activity objectively-measured with accelerometry
Time Frame
Change from baseline to 12 and 26 weeks
Title
Behavioral adherence assessed by session and self-monitoring completion
Time Frame
26 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://sites.northwestern.edu/pacestudy/info/
Description
PACE Research Study

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Patient-Centered Weight Loss Program for Knee Replacement Patients

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