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Healthy Living Program for Knee Replacement Recovery

N/A
Recruiting
Led By Christine Pellegrini, PhD
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
have a body mass index between 27-45 kg/m2
Have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will test if a weight-loss program can help people who recently had knee surgery lose weight, become more active, and relieve pain and stiffness.

Who is the study for?
This trial is for adults who've had knee replacement surgery within the past 6 months, have a BMI of 27-45 kg/m2, and can access the internet with a compatible device. They should be willing to attend four in-person assessments and speak English. It's not for those in other weight loss programs, planning major relocations or additional knee surgeries soon, or with conditions that limit mobility like spinal stenosis.Check my eligibility
What is being tested?
The study compares two programs: PACE Weight Loss program aimed at improving weight loss and physical activity post-knee replacement versus Chronic Disease Self-Management program. The goal is to see which one leads to better outcomes in terms of weight loss, pain relief, improved function, and cost-effectiveness.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, side effects are minimal but may include discomfort from increased physical activity or dietary changes as part of the PACE Weight Loss program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 27 and 45.
Select...
I had a knee replacement less than 6 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body weight at 6 months
Secondary outcome measures
Change in Chair Stands at 12 months
Change in Chair Stands at 18 months
Change in Chair Stands at 6 months
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PACE Weight Loss ProgramExperimental Treatment1 Intervention
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 II: Chronic Disease Self-Management ProgramPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,655 Total Patients Enrolled
43 Trials studying Obesity
12,698 Patients Enrolled for Obesity
University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,209 Total Patients Enrolled
31 Trials studying Obesity
8,675 Patients Enrolled for Obesity
Christine Pellegrini, PhDPrincipal InvestigatorUniversity of South Carolina
1 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

PACE Weight Loss program Clinical Trial Eligibility Overview. Trial Name: NCT05190666 — N/A
Obesity Research Study Groups: Chronic Disease Self-Management Program, PACE Weight Loss Program
Obesity Clinical Trial 2023: PACE Weight Loss program Highlights & Side Effects. Trial Name: NCT05190666 — N/A
PACE Weight Loss program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190666 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for this scientific experiment?

"Affirmative. Clinicaltrials.gov data reveals that this clinical trial, which was first posted on the 4th of January 2022, is actively recruiting volunteers. Approximately 250 people are needed from a single medical site."

Answered by AI

What is the upper limit of enrollees for this research project?

"Affirmative. Clinicaltrials.gov records that this clinical trial is in the process of participant recruitment and was posted on April 1st 2022, with its most recent update being June 7th 2022. The research team behind it are looking for 250 volunteers based out of a single site."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
How old are they?
18 - 65
What site did they apply to?
University of South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I had knee replacement and have continued pain which I’m sure is part of being overweight.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Healthy Living After Knee Replacement
Christine A Pellegrini, PhD 2022. "Healthy Living After Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190666.
~93 spots leftby Aug 2025
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