Patient-Centered Weight Loss Program for Knee Replacement Patients

NCT02728661 | Completed Phase 1 DMC

• 1 other identifier: K12HS023011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

ARTHROPLASTY, REPLACEMENT

Outcome Measures

Primary Outcomes (1)

• Change in weight measured with a balance-beam scale

  Change from baseline to 12 and 26 weeks

Secondary Outcomes (2)

• Change in physical function assessed by the timed up and go

  Change from baseline to 12 and 26 weeks

• Change in pain measured by WOMAC

  Change from baseline to 12 and 26 weeks

Other Outcomes (2)

• Change in physical activity objectively-measured with accelerometry

  Change from baseline to 12 and 26 weeks

• Behavioral adherence assessed by session and self-monitoring completion

  26 weeks post-op

Study Arms (2)

PACE

EXPERIMENTAL

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.

Behavioral: PACE

Delayed PACE

EXPERIMENTAL

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.

Behavioral: Delayed PACE

Interventions

PACE BEHAVIORAL

PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.

PACE

Delayed PACE BEHAVIORAL

Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.

Delayed PACE

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Links

• PACE Research Study

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 5, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)