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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853497
• Other study ID #: STUDY00149595
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: Steve Herrmann, PhD
• Phone: 913-588-8305
• Email: sherrmann[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Obesity
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Retention Feasibility	Feasibility will be based on retention of = 80% participants (i.e., <20% participant dropout).	6 Months
Primary	Participant Attendance Feasibility	Feasibility will be based on = 80% attendance at behavioral counseling sessions.	6 Months
Secondary	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
Secondary	Fat Mass (kg)	Changes in fat mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)	6 Months
Secondary	Fat Free Mass (kg)	Changes in fat free mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)	6 Months
Secondary	Body Weight (kg)	Changes in body weight (kg) will be compared between study arms using a calibrated body weight scale.	6 Months
Secondary	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