Healthy Living After Knee Replacement

Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty; Overweight and Obesity
• Intervention / Treatment: Behavioral: PACE Weight Loss program; Behavioral: Chronic Disease Self-Management

Detailed Description

Participants will be randomized to either a weight loss program or chronic disease self-management program. Both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. Monthly calls with occur between months 13-18. Assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen Wingard; Phone Number: 803-777-1889; Email: ewingard@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Christine Pellegrini, PhD.; Phone Number: 803-777-0911; Email: cpellegrini@sc.edu
      • Principal Investigator: Christine Pellegrini, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants must:

• have a body mass index between 25-45 kg/m2
• have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment
• have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
• completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
• be English-speaking and able to read consent and study materials written in English
• be willing to attend 4 in-person assessments.

Exclusion Criteria:

• have any contraindications to diet or weight loss
• undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
• have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
• are taking anti-obesity medications
• are enrolled in a formal weight loss program
• had or are planning to have bariatric/gastric/lap band surgery
• are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PACE Weight Loss Program; Participants randomized to this arm will receive personalized diet, activity, and weight loss goals as well as tools to self-monitor behaviors and weight. To facilitate changes, participants will receive coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.	Behavioral: PACE Weight Loss program; 12 month phone-based behavioral weight loss program
Sham Comparator: Chronic Disease Self-Management Program; Participants randomized to this arm will receive a chronic disease self-management program including a self-management book. Participants will receive regular calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.	Behavioral: Chronic Disease Self-Management; 12 month phone-based chronic disease self-management program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight at 6 months	kg	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WOMAC pain subscale at 6 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	6 months
Change in WOMAC pain subscale at 12 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	12 months
Change in WOMAC pain subscale at 18 months	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	18 months
Change in Six Minute Walk Duration at 6 months	Physical function assessed with the six minute walk test (feet)	6 months
Change in Six Minute Walk Duration at 12 months	Physical function assessed with the six minute walk test (feet)	12 months
Change in Six Minute Walk Duration at 18 months	Physical function assessed with the six minute walk test (feet)	18 months
Change in Timed Up & Go at 6 months	Physical function assessed with the Timed Up & Go Test (seconds)	6 months
Change in Timed Up & Go at 12 months	Physical function assessed with the Timed Up & Go Test (seconds)	12 months
Change in Timed Up & Go at 18 months	Physical function assessed with the Timed Up & Go Test (seconds)	18 months
Change in Chair Stands at 6 months	Physical function assessed with the Chair stand test (# of chair stands)	6 months
Change in Chair Stands at 12 months	Physical function assessed with the Chair stand test (# of chair stands)	12 months
Change in Chair Stands at 18 months	Physical function assessed with the Chair stand test (# of chair stands)	18 months
Change in Moderate to vigorous intensity physical activity at 6 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	6 months
Change in Moderate to vigorous intensity physical activity at 12 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	12 months
Change in Moderate to vigorous intensity physical activity at 18 months	Objectively measured by Actigraph accelerometer (>=2020 counts/min)	18 months
Change in body weight at 12 months	kg	12 months
Change in body weight at 18 months	kg	18 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Christine Pellegrini, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Anticipated): August 30, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: Pro00109459; R01AG070004 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will also make de-identified study data available 12 months after the primary manuscript is published.
• IPD Sharing Time Frame: 12 months after primary manuscript is published
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No