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

University of Kansas

Status

Completed

Conditions

Obesity

Arthropathy of Knee

Treatments

Behavioral: Multi-Component Weight Loss Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05853497

STUDY00149595

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.