Clinical trial NCT05190666: Healthy Living After Knee Replacement
Official title: Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty
Overweight and Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-01-13
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 cost effective, as compared to a chronic disease self-management program.

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 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.

Eligibility 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.

Primary outcomes:
measure: Change in body weight at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in WOMAC pain subscale at 6 months
timeFrame: 6 months
measure: Change in WOMAC pain subscale at 12 months
timeFrame: 12 months
measure: Change in WOMAC pain subscale at 18 months
timeFrame: 18 months
measure: Change in Six Minute Walk Duration at 6 months
timeFrame: 6 months
measure: Change in Six Minute Walk Duration at 12 months
timeFrame: 12 months
measure: Change in Six Minute Walk Duration at 18 months
timeFrame: 18 months
measure: Change in Timed Up & Go at 6 months
timeFrame: 6 months
measure: Change in Timed Up & Go at 12 months
timeFrame: 12 months
measure: Change in Timed Up & Go at 18 months
timeFrame: 18 months
measure: Change in Chair Stands at 6 months
timeFrame: 6 months
measure: Change in Chair Stands at 12 months
timeFrame: 12 months
measure: Change in Chair Stands at 18 months
timeFrame: 18 months
measure: Change in Moderate to vigorous intensity physical activity at 6 months
timeFrame: 6 months
measure: Change in Moderate to vigorous intensity physical activity at 12 months
timeFrame: 12 months
measure: Change in Moderate to vigorous intensity physical activity at 18 months
timeFrame: 18 months
measure: Change in body weight at 12 months
timeFrame: 12 months
measure: Change in body weight at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Christine Pellegrini, PhD
role: PRINCIPAL_INVESTIGATOR
References: