ObesityNCT04015011
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
A study testing LCD Intervention in people with Obesity, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- LCD Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Investigating the Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
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
- Being tested
- LCD Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCD InterventionCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Low Calorie Diet (LCD) diet intervention | Experimental | In person or video conference Receives: Combination Product: LCD Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 18 Months
Change in mobility during 30-sec chair stand
Measured: 18 Months
Change in mobility during 40-meter fast paced walk
Measured: 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
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start25 Jul 2019
- Primary completion30 Jun 2020
- Study completion30 Sep 2021
Why it stopped: study enrollment ended early due to covid and lack of continued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015011
- Sponsor's protocol ID
- 19-00319
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2019
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
- ClinicalTrials.gov ID
- NCT04015011
- Acronym / sponsor ID
- 19-00319
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study enrollment ended early due to covid and lack of continued funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Calorie Diet (LCD) diet intervention | Experimental | Combination Product: LCD InterventionIn person or video conference |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCD Interventioncomposed 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. | Combination product | Low Calorie Diet (LCD) diet intervention |
Primary outcome
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
Results and safety
The study was stopped early (reason given: study enrollment ended early due to covid and lack of continued funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCD Intervention in people with Obesity, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study enrollment ended early due to covid and lack of continued funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: up to 18 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.