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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG070004 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACE Weight Loss Program | Experimental | 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. |
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| Chronic Disease Self-Management Program | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACE Weight Loss program | Behavioral | 12 month phone-based behavioral weight loss program |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight at 6 months | kg | 6 months |
| 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) |
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Inclusion Criteria:
Participants must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Pellegrini, PhD | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
We will also make de-identified study data available 12 months after the primary manuscript is published.
12 months after primary manuscript is published
Open
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Chronic Disease Self-Management | Behavioral | 12 month phone-based chronic disease self-management program |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |