Status:
RECRUITING
Healthy Living After Knee Replacement
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Arthroplasty
Overweight and Obesity
Eligibility:
All Genders
Phase:
NA
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 co...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05190666
Start Date
January 4 2022
End Date
December 30 2026
Last Update
May 2 2025
Active Locations (1)
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1
University of South Carolina
Columbia, South Carolina, United States, 29208