Clinical trial NCT05735873: The Clinical Impact of Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
Official title: The Clinical Impact of a Low-energy Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Hypertension
Type 2 Diabetes
Obesity
Keywords: Caloric Restriction
Low energy diet
Value-based care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study. Case series.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Change from Baseline to 12 weeks in Numeric Pain Rating Scale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change from Baseline to 12 weeks in Patient Reported Outcome Measurement Information System Physical Function10
timeFrame: Baseline to 12 weeks
measure: Change from Baseline to 12 weeks in Knee Osteoarthritis Outcome Score Subscales
timeFrame: Baseline to 12 weeks
measure: Change from Baseline to 12 weeks in the Western Ontario and McMasters Osteoarthritis index
timeFrame: Baseline to 12 weeks
measure: Change from Baseline to 12 weeks in Hemoglobin A1C
timeFrame: Baseline to 12 weeks
measure: Change from Baseline to 12 weeks in systolic blood pressure
timeFrame: Baseline to 12 weeks
measure: Change from Baseline to 12 weeks in diastolic blood pressure
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
References: