A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement

Obesity, specifically BMIs ≥35 or 40 kg/m2, are associated with an increased probability of poor outcomes of Total Knee Arthroplasty (TKA) including increased pain, risk for infection, poor joint function, and increased rates of hospital readmissions. Several orthopedic and public health organizations recommend weight loss prior to TJA for individuals with overweight/obesity. However, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of TKA is extremely limited and is based primarily on non-randomized observational studies. Thus, to gain further insight regarding the feasibility and potential effectiveness of pre-surgical weight loss on outcomes of TKA, the proposed pilot trial will randomize 30 patients (age 50-75 yrs., BMI 35<40 kg/m2) scheduled for TKA through The University of Kansas Health System Department of Orthopedics and Sports Medicine (KUOrtho) to a multi-component weight loss (3-mo. pre-TKA, very low-calorie diet) and maintenance intervention (3-mo. post TKA, conventional maintenance diet) or standard care control which will include no dietary or weight loss advice. The weight loss/maintenance interventions will include reduced energy intake or energy intake prescribed for weight loss maintenance, increased physical activity, and individual behavior counseling. Outcomes will be assessed 1) baseline, i.e., 3 mos. prior to surgery, 2) 3 mos. i.e., at the completion of the weight loss intervention prior to TKA, 3) within a minimum of 2 weeks post TKA, and 4) 3 mos. post-TKA, i.e., after completion of the weight maintenance intervention to assess the feasibility and effectiveness of a remotely delivered multi-component pre-TKA weight loss and a post-TKA weight maintenance intervention.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Arthropathy of Knee
• Intervention / Treatment: Behavioral: Multi-Component Weight Loss Intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steve Herrmann, PhD; Phone Number: 913-588-8305; Email: sherrmann@kumc.edu
• Study Contact Backup: Name: Jeff Honas, MPH; Email: jhonas2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Steve Herrmann; Email: sherrmann@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 50-75 years
• BMI: 35 to ≤40 kg/m2
• Patient of KU Health System Department of Orthopedics and Sports Medicine (KUOrtho)meeting all requirements for TKA surgery.
• TKA surgical date scheduled ≥3 mos. from consent
• Own a Bluetooth enabled computer, tablet, or smart phone with the ability to join remote telehealth sessions and sync study self-monitoring devices.

Exclusion Criteria:

• Weight loss ≥10 pounds in previous 6 months
• Dairy/milk protein allergy
• Currently pregnant/breastfeeding or planning to become pregnant during the study
• Currently being treated for an eating disorder or history of an eating disorder diagnosis
• Pacemaker
• Current Cancer
• Diabetes Type 1 (insulin dependent)
• Hyperuricemia (untreated)
• Inflammatory bowel disease (active)
• Liver disease requiring protein restriction
• Myocardial infarction within last 3 months
• Abnormal ECG
• Renal insufficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care Control; Standard care
Experimental: Intervention; Multi-component weight loss intervention	Behavioral: Multi-Component Weight Loss Intervention; The intervention group will receive weekly 1-on-1 health coaching with a very-low calorie nutrition plan prior to total knee replacement and a conventional weight maintenance nutrition plan after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention Feasibility	Feasibility will be based on retention of ≥ 80% participants (i.e., <20% participant dropout).	6 Months
Participant Attendance Feasibility	Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee and Lower Extremity Physical Function (OARSI Test)	Knee and lower extremity function will be compared between study arms using the Osteoarthritis Research Society International (OARSI) physical function test battery.	6 Months
Fat Mass (kg)	Changes in fat mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)	6 Months
Fat Free Mass (kg)	Changes in fat free mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)	6 Months
Body Weight (kg)	Changes in body weight (kg) will be compared between study arms using a calibrated body weight scale.	6 Months
Self reported knee function	Self-reported knee function will be compared between study arms using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.	6 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: South Dakota State University
• Investigators: Principal Investigator: Steve Herrmann, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: STUDY00149595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No