Osteoarthritis, KneeNCT05735873
The Clinical Impact of Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
A study testing Low-energy diet in people with Osteoarthritis, Knee and Hypertension, run by Vanderbilt University Medical Center.
Trial summary
Diet interventions (e.g., low-energy diets) are recommended as a treatment for obesity, obese patients with osteoarthritis, hypertension (HTN), and type 2 diabetes (T2D). However, these diets are not a common part of the care plan partly because it is not financially feasible to discuss and offer them in medical… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Hypertension, Type 2 Diabetes
- What is being tested?
- Low-energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Jun 2025
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 to 80 years of age
- Greater than, or equal to, four weeks of knee pain on the majority of days
- Weightbearing Xray within one year of enrollment demonstrating Kellgren Lawrence grade 1-4 changes
- Diagnosis of essential hypertension
- Diagnosis of type two diabetes.
- BMI >= 30kg/m2
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- Consistent access to the internet
- Available on Thursdays for research visits
- Available each Sunday for 12 weeks between 4 pm and 6 pm to pick up the LED meals
Who cannot join
- Under 40 years of age
- Over 80 years of age
- Duration of symptoms less than four weeks
- Arthritis secondary to immune-mediated, infectious, or gout.
- Malignant hypertension
- Hypertension with heart-failure
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- Secondary causes of hypertension
- Celiac disease, inflammatory bowel disease, gastroparesis, or other gastrointestinal disorders that can flare and reduce absorption.
- Tree nut or legume allergies
- Received any intraarticular knee injections in the past month.
- Using topiramate, phentermine, or glucagon-like peptide (GLP-1) agonists (e.g., semaglutide or dulaglutide)
About this study
Official title: The Clinical Impact of a Low-energy Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
Diet interventions (e.g., low-energy diets) are recommended as a treatment for obesity, obese patients with osteoarthritis, hypertension (HTN), and type 2 diabetes (T2D). However, these diets are not a common part of the care plan partly because it is not financially feasible to discuss and offer them in medical offices reimbursed with the standard fee-for-service model. New reimbursement models, like value-based care (VBC), exist. It may be financially feasible to offer diet interventions, like premade and delivered meal plans to address these medical issues. This pilot study will help determine if a more extensive prospective study of the clinical effects of a delivered, premade low-energy diet (LED) on clinical markers of these disorders, as well as future cost-benefit analyses.
Methods: A case series of five obese subjects with knee osteoarthritis, HTN, and T2D receive a LED for 12 weeks. The primary outcome is the change in the Numeric Pain Rating Scale (NPRS) at 12 weeks. Secondary outcome measures include the change in other patient-reported outcomes between the start and end of the study, changes in weight, changes in measures of HTN and T2D, and the proportion of subjects using non-protocol interventions.
Hypothesis: Subjects randomized to the diet intervention will demonstrate a clinically significant improvement in NRPS score (2 points), a clinically significant weight reduction (15%), a 50% improvement in systolic and diastolic blood pressure, 1.0% reduction in Hemoglobin A1C levels (HgA1C), and lower utilization of non-protocol treatments at 12 weeks.
Read the detailed description
Screening and Enrollment:
The subjects will be recruited from Vanderbilt University Medical Center's (VUMC) department of orthopaedics recent census of patients with the diagnosis codes for osteoarthritis (OA) of the knees (M17.11, M17.12, and M17.0), essential hypertension without heart failure (I11.9), type 1 diabetes (E10.) or type two diabetes controlled with insulin (E11.Z79.84). In addition, recruitment emails will be sent to VUMC employees using the VUMC email-based research notification system.
A Key Study Person (KSP) will conduct a screening call to review the inclusion and exclusion criteria. The potential subjects' charts will also be accessed to confirm age, sex, recent weight, and recent height. Eligible candidates would then meet a KSP for enrollment during a research visit.
Each patient will be asked to complete a questionnaire at the enrollment and 12-week research visits with the primary investigator. The questionnaire will be administered electronically into REDCap.
This questionnaire will survey the use of non-protocol interventions related to OA at any point during the intervention, such as (corticosteroid injection, viscosupplementation injection, platelet-rich plasma injection, weight loss prescription, or physical therapy) or in the week before completing the questionnaire (topical analgesic, oral analgesic, brace, or assistive walking device). The questionnaire will also include the following validated surveys for pain and function: Patient-reported Outcomes Measurement Information System Global Health Physical Function 10 (PROMIS-PF10), Numeric Pain Rating Scale (NRPS), Knee injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.
In office measurements After enrollment, subjects will have their weight measured in their undergarments and an office gown. Their blood pressure will be collected with them seated on their left arm. Blood pressure will be measured using an automated sphygmomanometer (Philips Sure Signs VS4) three times with five minutes between measurements. The average systolic and diastolic measurements will be used as the research values.
A subject's height and weight will also be measured using an electronic scale (AWS SC2KGA ) while you are barefoot, wearing only a medical gown for full coverage. Your weight will be recorded as the weight of your body with the gown minus the weight of the gown alone.
These measurements will be collected at the enrollment and 12-week visits (research visits). Research visits will take place on Thursday afternoons at Vanderbilt Orthopaedics Franklin (VOF, 206 Bedford Way, Franklin, TN 37067)
Laboratories The Primary Investigator (PI) will collect blood for a HgbA1C at the research visits.
LED Meals Subjects will receive instructions on ordering their meals from the low-calorie meal service. Food will be available for pick up at VOF each Sunday between 4 pm and 6 pm for 12 weeks. Patients will receive reminders from a KSP to attend their research visits, complete their outcome questionnaires, and obtain other measurements and labs. Data from the questionnaire results will be de-identified. Then the PI will analyze the data, blind to the subjects and their interventions.
After enrollment, subjects can continue to seek care from their typical clinicians without instruction from the research team. There will not be any instruction from the research team to pursue, or avoid, care from their usual healthcare providers. The utilization of non-protocol interventions, like NSAID prescriptions or corticosteroid injections, will be monitored using the research visit questionnaires.
- Conditions
- Osteoarthritis, Knee, Hypertension, Type 2 Diabetes, Obesity
- Being tested
- Low-energy diet
- Keywords
- Caloric Restriction, Low energy diet, Value-based care
- Medical subject headings
- Osteoarthritis, Knee, Hypertension, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-energy dietOther
Twenty-one pre-made, low-energy meals delivered weekly to the subject for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-energy diet arm | Experimental | Subjects who receive low-energy premade meals for three meals each day for 12 weeks. Receives: Other: Low-energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 12 weeks in Numeric Pain Rating Scale
11-point scale that quantifies the amount of pain experienced over the preceding week. The score goes from 0 (no pain) to 10 (worst pain).
Measured: Baseline to 12 weeks
Secondary outcomes (6)
Change from Baseline to 12 weeks in Patient Reported Outcome Measurement Information System Physical Function10
A ten-question patient-reported outcome survey assesses how a subject's overall health impacts physical function. Each question has five responses, from 0 (no difficulty) to 5 (cannot do/unable to do). The sum of each response divided by the maximum score is reported as a percentage. 0% indicates the subject has no difficulty with global physical function; 100% indicates the subject is experiencing the maximum amount of limitation with physical function.
Measured: Baseline to 12 weeks
Change from Baseline to 12 weeks in Knee Osteoarthritis Outcome Score Subscales
A 42-question Patient-reported outcome measures survey. It assesses the impact of knee osteoarthritis on five sub-scales: pain, symptoms, activities of daily living, recreation, and quality of life. A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for each sub-scale.
Measured: Baseline to 12 weeks
Change from Baseline to 12 weeks in the Western Ontario and McMasters Osteoarthritis index
A 24-question patient-reported outcome survey derived from the Knee Osteoarthritis Outcome Score reports a single score instead of sub-scales. Each question has five responses, from 0 (no difficulty) to 5 (extreme difficulty). The sum of each response divided by the maximum score is reported as a percentage. 0% indicates the subject is having no difficulty from osteoarthritis in the knee; 100% indicates the subject is experiencing the maximum amount of problem.
Measured: Baseline to 12 weeks
Change from Baseline to 12 weeks in Hemoglobin A1C
A measure of the average blood glucose level over time
Measured: Baseline to 12 weeks
Change from Baseline to 12 weeks in systolic blood pressure
A measure of the change in systolic blood pressure relative to a benchmark of 120 mm of Mercury
Measured: Baseline to 12 weeks
Change from Baseline to 12 weeks in diastolic blood pressure
A measure of the change in diastolic blood pressure relative to a benchmark of 80 mm of Mercury
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study. Case series.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Scott, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735873
- Sponsor's protocol ID
- U13795
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of a Low-energy Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
- ClinicalTrials.gov ID
- NCT05735873
- Acronym / sponsor ID
- U13795
- Conditions
- Osteoarthritis, Knee, Hypertension, Type 2 Diabetes, Obesity
- Keywords
- Caloric Restriction, Low energy diet, Value-based care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
Diet interventions (e.g., low-energy diets) are recommended as a treatment for obesity, obese patients with osteoarthritis, hypertension (HTN), and type 2 diabetes (T2D). However, these diets are not a common part of the care plan partly because it is not financially feasible to discuss and offer them in medical offices reimbursed with the standard fee-for-service model. New reimbursement models, like value-based care (VBC), exist. It may be financially feasible to offer diet interventions, like premade and delivered meal plans to address these medical issues. This pilot study will help determine if a more extensive prospective study of the clinical effects of a delivered, premade low-energy diet (LED) on clinical markers of these disorders, as well as future cost-benefit analyses.
Methods: A case series of five obese subjects with knee osteoarthritis, HTN, and T2D receive a LED for 12 weeks. The primary outcome is the change in the Numeric Pain Rating Scale (NPRS) at 12 weeks. Secondary outcome measures include the change in other patient-reported outcomes between the start and end of the study, changes in weight, changes in measures of HTN and T2D, and the proportion of subjects using non-protocol interventions.
Hypothesis: Subjects randomized to the diet intervention will demonstrate a clinically significant improvement in NRPS score (2 points), a clinically significant weight reduction (15%), a 50% improvement in systolic and diastolic blood pressure, 1.0% reduction in Hemoglobin A1C levels (HgA1C), and lower utilization of non-protocol treatments at 12 weeks.
Detailed description
Screening and Enrollment:
The subjects will be recruited from Vanderbilt University Medical Center's (VUMC) department of orthopaedics recent census of patients with the diagnosis codes for osteoarthritis (OA) of the knees (M17.11, M17.12, and M17.0), essential hypertension without heart failure (I11.9), type 1 diabetes (E10.) or type two diabetes controlled with insulin (E11.Z79.84). In addition, recruitment emails will be sent to VUMC employees using the VUMC email-based research notification system.
A Key Study Person (KSP) will conduct a screening call to review the inclusion and exclusion criteria. The potential subjects' charts will also be accessed to confirm age, sex, recent weight, and recent height. Eligible candidates would then meet a KSP for enrollment during a research visit.
Each patient will be asked to complete a questionnaire at the enrollment and 12-week research visits with the primary investigator. The questionnaire will be administered electronically into REDCap.
This questionnaire will survey the use of non-protocol interventions related to OA at any point during the intervention, such as (corticosteroid injection, viscosupplementation injection, platelet-rich plasma injection, weight loss prescription, or physical therapy) or in the week before completing the questionnaire (topical analgesic, oral analgesic, brace, or assistive walking device). The questionnaire will also include the following validated surveys for pain and function: Patient-reported Outcomes Measurement Information System Global Health Physical Function 10 (PROMIS-PF10), Numeric Pain Rating Scale (NRPS), Knee injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.
In office measurements After enrollment, subjects will have their weight measured in their undergarments and an office gown. Their blood pressure will be collected with them seated on their left arm. Blood pressure will be measured using an automated sphygmomanometer (Philips Sure Signs VS4) three times with five minutes between measurements. The average systolic and diastolic measurements will be used as the research values.
A subject's height and weight will also be measured using an electronic scale (AWS SC2KGA ) while you are barefoot, wearing only a medical gown for full coverage. Your weight will be recorded as the weight of your body with the gown minus the weight of the gown alone.
These measurements will be collected at the enrollment and 12-week visits (research visits). Research visits will take place on Thursday afternoons at Vanderbilt Orthopaedics Franklin (VOF, 206 Bedford Way, Franklin, TN 37067)
Laboratories The Primary Investigator (PI) will collect blood for a HgbA1C at the research visits.
LED Meals Subjects will receive instructions on ordering their meals from the low-calorie meal service. Food will be available for pick up at VOF each Sunday between 4 pm and 6 pm for 12 weeks. Patients will receive reminders from a KSP to attend their research visits, complete their outcome questionnaires, and obtain other measurements and labs. Data from the questionnaire results will be de-identified. Then the PI will analyze the data, blind to the subjects and their interventions.
After enrollment, subjects can continue to seek care from their typical clinicians without instruction from the research team. There will not be any instruction from the research team to pursue, or avoid, care from their usual healthcare providers. The utilization of non-protocol interventions, like NSAID prescriptions or corticosteroid injections, will be monitored using the research visit questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study. Case series.
| Arm | Type | Receives |
|---|---|---|
| Low-energy diet arm | Experimental | Other: Low-energy dietSubjects who receive low-energy premade meals for three meals each day for 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 40 to 80 years of age
- Greater than, or equal to, four weeks of knee pain on the majority of days
- Weightbearing Xray within one year of enrollment demonstrating Kellgren Lawrence grade 1-4 changes
- Diagnosis of essential hypertension
- Diagnosis of type two diabetes.
Key exclusion criteria (11 listed)
- Under 40 years of age
- Over 80 years of age
- Duration of symptoms less than four weeks
- Arthritis secondary to immune-mediated, infectious, or gout.
- Malignant hypertension
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 |
|---|---|---|
| Low-energy dietTwenty-one pre-made, low-energy meals delivered weekly to the subject for 12 weeks. | Other | Low-energy diet arm |
Primary outcome
Change from Baseline to 12 weeks in Numeric Pain Rating Scale
Time frame: Baseline to 12 weeks
11-point scale that quantifies the amount of pain experienced over the preceding week. The score goes from 0 (no pain) to 10 (worst pain).
6 secondary outcomes
Change from Baseline to 12 weeks in Patient Reported Outcome Measurement Information System Physical Function10
Time frame: Baseline to 12 weeks
Change from Baseline to 12 weeks in Knee Osteoarthritis Outcome Score Subscales
Time frame: Baseline to 12 weeks
Change from Baseline to 12 weeks in the Western Ontario and McMasters Osteoarthritis index
Time frame: Baseline to 12 weeks
Change from Baseline to 12 weeks in Hemoglobin A1C
Time frame: Baseline to 12 weeks
Change from Baseline to 12 weeks in systolic blood pressure
Time frame: Baseline to 12 weeks
Change from Baseline to 12 weeks in diastolic blood pressure
Time frame: Baseline to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Low-energy diet in people with Osteoarthritis, Knee and Hypertension, run by Vanderbilt University Medical Center.
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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 from Baseline to 12 weeks in Numeric Pain Rating Scale (time frame: Baseline to 12 weeks). 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 9 Oct 2024.