Healthy Living After Knee Replacement

Last updated: April 29, 2025
Sponsor: University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Orthopedics

Hypertriglyceridemia

Treatment

Chronic Disease Self-Management

PACE Weight Loss program

Clinical Study ID

NCT05190666
Pro00109459
R01AG070004
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, orrevision) <6 months prior to baseline assessment

  • have a computer, tablet, or smartphone with active internet access to self-monitoronline 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

Exclusion Criteria:

  • have any contraindications to diet or weight loss

  • undergo simultaneous bilateral knee replacement or have a scheduled or anticipatedknee replacement for the contralateral knee within the next 18 months

  • have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinalstenosis, 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 18months.

Study Design

Total Participants: 212
Treatment Group(s): 2
Primary Treatment: Chronic Disease Self-Management
Phase:
Study Start date:
January 04, 2022
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • University of South Carolina

    Columbia, South Carolina 29208
    United States

    Active - Recruiting

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