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

NCT05853497 | Completed

• 1 other identifier: STUDY00149595
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthropathy of Knee; Obesity

Keywords

Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Knee and Lower Extremity Physical Function (OARSI Test)

  6 Months

• Fat Mass (kg)

  6 Months

• Fat Free Mass (kg)

  6 Months

• Body Weight (kg)

  6 Months

• Self reported knee function

  6 Months

Study Arms (2)

Standard Care Control

NO INTERVENTION

Standard care

Intervention

EXPERIMENTAL

Multi-component weight loss intervention

Behavioral: Multi-Component Weight Loss Intervention

Interventions

Multi-Component Weight Loss Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• South Dakota State University: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steve Herrmann, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 10, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: September 9, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)