Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes

NCT04015011 | Terminated

• 1 other identifier: 19-00319
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Total Knee Replacement (TKR) significantly improves function, pain, and overall quality of life in patients with end-stage arthritis of the knee. However, studies show that obesity increases complications and costs associated with TKR. The American Academy of Orthopaedic Surgeons (AAOS) clinical guidelines recommend that patients with a BMI \> 25kg/m2 lose 5% of their body weight prior to surgery. Consequently, although it is not clear how to patients or providers achieve weight loss in this population, some providers and hospitals decline to perform TKR in patients with obesity. Low Calorie meal replacement diets (LCD) are a feasible way to safely promote short-term weight loss of 8-15% at 3-6 months prior to some elective surgeries. This is a pilot efficacy study to test whether a short-term program using a 3-month LCD leads to weight loss and improved patient reported and functional outcomes. 75 patients eligible for knee replacement surgery and willing to undergo non-operative weight management treatment at NYU Langone Comprehensive Obesity Center. This study will establish feasibility and weight loss outcomes in preparation for a multicenter effectiveness trial.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• Change in weight

  Patients who have had recent knee replacement will be weighed at screening, week 5-7, week 11-13, and 30-120 days post surgery

  up to 18 Months

• Change in mobility during 30-sec chair stand

  18 Months

• Change in mobility during 40-meter fast paced walk

  18 Months

• Change in quality of life measured by SF-36 questionnaire

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: * vitality * physical functioning * bodily pain * general health perceptions * physical role functioning * emotional role functioning * social role functioning * mental health

  18 Months

Study Arms (1)

Low Calorie Diet (LCD) diet intervention

EXPERIMENTAL

In person or video conference

Combination Product: LCD Intervention

Interventions

LCD Intervention COMBINATION_PRODUCT

composed of approximately 1,080 kcal/day, which includes 3 New Direction Meal Replacements containing 200 kcal (27g protein, 12g carbhydrate, 2g fiber), 1 protein bar containing 160 kcal (5 g protein, 18g carbohydrate, 5g fiber, 2g sugar alcohol), and a 350-calorie controlled meal of protein and vegetables that the patient will make on his/ her own.

Low Calorie Diet (LCD) diet intervention

Eligibility Criteria

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

You may qualify if:

• BMI 35-45 kg/m2
• Any ethnicity
• Able to speak, read, and write in English
• Have knee replacement surgery already planned by the surgeon
• Plan to undergo knee replacement surgery within 3-6 months post LCD intervention
• Willing to commute to NYU Langone Weight Management Clinic at the start of the dietary intervention, midway through, and end of intervention

You may not qualify if:

• Uncontrolled type 2 diabetes, defined as HbA1c \> 9%
• If smokes cigarettes, must go through a 6 week cessation program first
• Type 1 diabetes
• Whey protein allergies
• Soy allergies
• Anyone in whom rapid weight loss is not indicated (e.g., ESRD or cirrhosis, metabolic cancer, abnormal 3 times UL liver enzyme labs)
• Current untreated or uncontrolled eating disorder (e.g., binge eating, bulimia)
• Rheumatoid arthritis
• In case a previous knee replacement surgery was done, the participant should wait at least 1 year from previous date of surgery
• Undergoing simultaneous bilateral knee replacement
• Enrolled in a formal weight loss program
• Taking anti-obesity medications
• Coexisting psychotic conditions requiring hospitalization or more intense treatment (e.g., bipolar mood disorder, severe depression)
• Abnormal CBC, and uric acid, must be treated prior to start of intervention
• Higher than 5.5 mU/L or lower than 0.3 mU/L TSH must be treated prior to start of LCD intervention

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 10, 2019
• Study Start: July 25, 2019
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

US (1)