Healthy Living After Knee Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement

Conditions
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Arthroplasty, Overweight and Obesity

Intervention / Treatment
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* Behavioral: PACE Weight Loss program
* Behavioral: Chronic Disease Self-Management


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACE Weight Loss Program<br>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<br>* 12 month phone-based behavioral weight loss program<br>|
| Sham Comparator: Chronic Disease Self-Management Program<br>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<br>* 12 month phone-based chronic disease self-management program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight at 6 months | kg | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC pain subscale at 6 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) | 6 months | 
| Change in WOMAC pain subscale at 12 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) | 12 months | 
| Change in WOMAC pain subscale at 18 months | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) | 18 months | 
| Change in Six Minute Walk Duration at 6 months | Physical function assessed with the six minute walk test (feet) | 6 months | 
| Change in Six Minute Walk Duration at 12 months | Physical function assessed with the six minute walk test (feet) | 12 months | 
| Change in Six Minute Walk Duration at 18 months | Physical function assessed with the six minute walk test (feet) | 18 months | 
| Change in Timed Up & Go at 6 months | Physical function assessed with the Timed Up & Go Test (seconds) | 6 months | 
| Change in Timed Up & Go at 12 months | Physical function assessed with the Timed Up & Go Test (seconds) | 12 months | 
| Change in Timed Up & Go at 18 months | Physical function assessed with the Timed Up & Go Test (seconds) | 18 months | 
| Change in Chair Stands at 6 months | Physical function assessed with the Chair stand test (# of chair stands) | 6 months | 
| Change in Chair Stands at 12 months | Physical function assessed with the Chair stand test (# of chair stands) | 12 months | 
| Change in Chair Stands at 18 months | Physical function assessed with the Chair stand test (# of chair stands) | 18 months | 
| Change in Moderate to vigorous intensity physical activity at 6 months | Objectively measured by Actigraph accelerometer (>=2020 counts/min) | 6 months | 
| Change in Moderate to vigorous intensity physical activity at 12 months | Objectively measured by Actigraph accelerometer (>=2020 counts/min) | 12 months | 
| Change in Moderate to vigorous intensity physical activity at 18 months | Objectively measured by Actigraph accelerometer (>=2020 counts/min) | 18 months | 
| Change in body weight at 12 months | kg | 12 months | 
| Change in body weight at 18 months | kg | 18 months |