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

NCT ID: NCT05853497

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-09-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Care Control

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Multi-component weight loss intervention

Group Type: EXPERIMENTAL

Multi-Component Weight Loss Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Dakota State University

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Herrmann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00149595

Identifier Type: -

Identifier Source: org_study_id