Weight loss program for adults after knee replacement
Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement
This study tests if a special weight loss program helps adults who have had knee replacement surgery lose weight and feel better compared to a self-management program over 18 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Sex | All |
| Sponsor | University of South Carolina Academic / other |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT05190666 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of a weight loss program specifically designed for adults who have undergone knee replacement surgery. Participants will be randomly assigned to either a weight loss program or a chronic disease self-management program, both delivered via phone. The study will assess various outcomes, including weight loss, physical activity, pain, and function over an 18-month period, with regular check-ins from health coaches. The goal is to determine if the weight loss program is more effective and cost-efficient compared to the self-management approach.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 25-45 who have had a knee replacement within the last six months.
Not a fit: Patients who have contraindications to diet or weight loss or those with mobility-limiting comorbidities unrelated to knee replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for patients recovering from knee replacement by promoting weight loss and enhancing physical function.
How similar studies have performed: Other studies have shown positive outcomes with similar weight loss interventions in post-surgical populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbia, South Carolina
- University of South Carolina — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christine Pellegrini, PhD — University of South Carolina
- Study coordinator: Ellen Wingard
- Email: ewingard@mailbox.sc.edu
- Phone: 803-777-1889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.