Healthy Living After Knee Replacement

Not Applicable

Recruiting

• Conditions: Arthroplasty; Overweight and Obesity
• Interventions: Behavioral: Chronic Disease Self-Management; Behavioral: PACE Weight Loss program

• Registration Number: NCT05190666
• Lead Sponsor: University of South Carolina

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-12-28
• Study Start: 2022-01-04
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Disease Self-Management Program	Chronic Disease Self-Management	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.
PACE Weight Loss Program	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight at 6 months	6 months	kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States