Healthy Living After 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.
Conditions:
🦠 Arthroplasty 🦠 Overweight and Obesity
🗓️ Study Start (Actual) 4 January 2022
🗓️ Primary Completion (Estimated) 30 August 2025
✅ Study Completion (Estimated) 30 June 2026
👥 Enrollment (Estimated) 212
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbia, South Carolina, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 December 2021
  • First Submitted that Met QC Criteria 12 January 2022
  • First Posted 13 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024