Healthy Living After Knee Replacement

University of South Carolina

Status: Active, not recruiting

Conditions: Arthroplasty; Overweight and Obesity

Treatments: Behavioral: PACE Weight Loss program; Behavioral: Chronic Disease Self-Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05190666

Pro00109459

R01AG070004 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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181 participants in 2 patient groups

PACE Weight Loss Program

Experimental group

Description:

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.

Treatment:

Behavioral: PACE Weight Loss program

Chronic Disease Self-Management Program

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Chronic Disease Self-Management