Healthy Living After Knee Replacement

N/AActive Not RecruitingNCT05190666

University of South Carolina181 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

181

Conditions

Arthroplasty Overweight and Obesity

Interventions

PACE Weight Loss programBEHAVIORAL

12 month phone-based behavioral weight loss program

Chronic Disease Self-ManagementBEHAVIORAL

12 month phone-based chronic disease self-management program

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of South Carolina

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Change in body weight at 6 months

Time frame: 6 months

Secondary Outcomes

Change in WOMAC pain subscale at 6 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time frame: 6 months

Change in WOMAC pain subscale at 12 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time frame: 12 months

Change in WOMAC pain subscale at 18 months

WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

Time frame: 18 months

Change in Six Minute Walk Duration at 6 months

Physical function assessed with the six minute walk test (feet)

Time frame: 6 months

Change in Six Minute Walk Duration at 12 months

Physical function assessed with the six minute walk test (feet)

Time frame: 12 months

Change in Six Minute Walk Duration at 18 months

Physical function assessed with the six minute walk test (feet)

Time frame: 18 months

Change in Timed Up & Go at 6 months

Physical function assessed with the Timed Up \& Go Test (seconds)

Time frame: 6 months

Change in Timed Up & Go at 12 months

Data from ClinicalTrials.gov

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