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出境医 / 临床实验 / Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes

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

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.


Condition or disease Intervention/treatment Phase
Obesity Combination Product: LCD Intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Investigating the Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2026
Arms and Interventions
Arm Intervention/treatment
Experimental: Low Calorie Diet (LCD) diet intervention
In person or video conference
Combination Product: LCD Intervention
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.

Outcome Measures
Primary Outcome Measures :
  1. Change in weight [ Time Frame: up to 18 Months ]
    Patients who have had recent knee replacement will be weighed at screening, week 5-7, week 11-13, and 30-120 days post surgery

  2. Change in mobility during 30-sec chair stand [ Time Frame: 18 Months ]
  3. Change in mobility during 40-meter fast paced walk [ Time Frame: 18 Months ]
  4. Change in quality of life measured by SF-36 questionnaire [ Time Frame: 18 Months ]

    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Change in weight [ Time Frame: up to 18 Months ]
    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 [ Time Frame: 18 Months ]
  • Change in mobility during 40-meter fast paced walk [ Time Frame: 18 Months ]
  • Change in quality of life measured by SF-36 questionnaire [ Time Frame: 18 Months ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Official Title  ICMJE A Pilot Study Investigating the Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE Combination Product: LCD Intervention
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.
Study Arms  ICMJE Experimental: Low Calorie Diet (LCD) diet intervention
In person or video conference
Intervention: Combination Product: LCD Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 14, 2021)
13
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
30
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015011
Other Study ID Numbers  ICMJE 19-00319
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NYU Langone Health
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP