Arthroplasty, Overweight and Obesity
Conditions
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.
Interventions
BEHAVIORALPACE Weight Loss program
12 month phone-based behavioral weight loss program
BEHAVIORALChronic Disease Self-Management
12 month phone-based chronic disease self-management program
Sponsors
University of South Carolina
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight at 6 months | 6 months | kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC pain subscale at 6 months | 6 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) |
| Change in WOMAC pain subscale at 12 months | 12 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) |
| Change in WOMAC pain subscale at 18 months | 18 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) |
| Change in Six Minute Walk Duration at 6 months | 6 months | Physical function assessed with the six minute walk test (feet) |
| Change in Six Minute Walk Duration at 12 months | 12 months | Physical function assessed with the six minute walk test (feet) |
| Change in Six Minute Walk Duration at 18 months | 18 months | Physical function assessed with the six minute walk test (feet) |
| Change in Timed Up & Go at 6 months | 6 months | Physical function assessed with the Timed Up \& Go Test (seconds) |
| Change in Timed Up & Go at 12 months | 12 months | Physical function assessed with the Timed Up \& Go Test (seconds) |
| Change in Timed Up & Go at 18 months | 18 months | Physical function assessed with the Timed Up \& Go Test (seconds) |
| Change in Chair Stands at 6 months | 6 months | Physical function assessed with the Chair stand test (# of chair stands) |
| Change in Chair Stands at 12 months | 12 months | Physical function assessed with the Chair stand test (# of chair stands) |
| Change in Chair Stands at 18 months | 18 months | Physical function assessed with the Chair stand test (# of chair stands) |
| Change in Moderate to vigorous intensity physical activity at 6 months | 6 months | Objectively measured by Actigraph accelerometer (\>=2020 counts/min) |
| Change in Moderate to vigorous intensity physical activity at 12 months | 12 months | Objectively measured by Actigraph accelerometer (\>=2020 counts/min) |
| Change in Moderate to vigorous intensity physical activity at 18 months | 18 months | Objectively measured by Actigraph accelerometer (\>=2020 counts/min) |
| Change in body weight at 12 months | 12 months | kg |
| Change in body weight at 18 months | 18 months | kg |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Pellegrini, PhD
University of South Carolina
Outcome results
None listed