Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LCD Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Calorie Diet (LCD) diet intervention
Arm Description
In person or video conference
Outcomes
Primary Outcome Measures
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
Change in mobility during 30-sec chair stand
Change in mobility during 40-meter fast paced walk
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04015011
Brief Title
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Official Title
A Pilot Study Investigating the Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
study enrollment ended early due to covid and lack of continued funding
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Calorie Diet (LCD) diet intervention
Arm Type
Experimental
Arm Description
In person or video conference
Intervention Type
Combination Product
Intervention Name(s)
LCD Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight
Description
Patients who have had recent knee replacement will be weighed at screening, week 5-7, week 11-13, and 30-120 days post surgery
Time Frame
up to 18 Months
Title
Change in mobility during 30-sec chair stand
Time Frame
18 Months
Title
Change in mobility during 40-meter fast paced walk
Time Frame
18 Months
Title
Change in quality of life measured by SF-36 questionnaire
Description
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
Time Frame
18 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
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