Healthy Living After Knee Replacement

NCT ID: NCT05190666

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2027-07-30

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.

Conditions

Arthroplasty; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PACE Weight Loss program

Intervention Type: BEHAVIORAL

12 month phone-based behavioral weight loss program

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.

Group Type: SHAM_COMPARATOR

Chronic Disease Self-Management

Intervention Type: BEHAVIORAL

12 month phone-based chronic disease self-management program

Interventions

PACE Weight Loss program

12 month phone-based behavioral weight loss program

Intervention Type: BEHAVIORAL

Chronic Disease Self-Management

12 month phone-based chronic disease self-management program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christine A Pellegrini, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Pellegrini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

University of South Carolina

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

R01AG070004

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00109459

Identifier Type: -

Identifier Source: org_study_id