Healthy Living After Knee Replacement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PACE Weight Loss Program 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. |
Behavioral: PACE Weight Loss program
12 month phone-based behavioral weight loss program
|
| Sham Comparator: Chronic Disease Self-Management Program 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. |
Behavioral: Chronic Disease Self-Management
12 month phone-based chronic disease self-management program
|
Outcome Measures
Primary Outcome Measures
- Change in body weight at 6 months [6 months]
kg
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants must:
-
have a body mass index between 27-45 kg/m2
-
have had a knee replacement (including primary, staged or independent bilateral, or revision) <12 weeks 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 ≥2 days 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Carolina | Columbia | South Carolina | United States | 29208 |
Sponsors and Collaborators
- University of South Carolina
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Christine Pellegrini, PhD, University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00109459
- R01AG070004