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 [LED] 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 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 results at different time points, KOOS/WOMAC/SF-12 questionnaire results, change in weight, changes in measures of hypertension 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), clinically significant reduction in weight (15%), 50% improvement in systolic and diastolic blood pressure, 1.0% reduction in HgA1C, and lower utilization of non-protocol treatments at 12 weeks.

Inclusion Criteria:40 to 80 years of ageGreater than, or equal to, four weeks of knee pain on the majority of daysWeightbearing Xray within one year of enrollment demonstrating K-L grade 1-4 changesDiagnosis of essential hypertensionDiagnosis of type two diabetes.BMI >= 30kg/m2Consistent access to the internetAvailable on Thursdays for research visitsAvailable each Sunday for 12 weeks between 4pm and 6pm to pick up the LED mealsExclusion Criteria:Under 40 years of ageOver 80 years of ageDuration of symptoms less than four weeksArthritis secondary to immune-mediated, infectious, or gout.Malignant hypertensionHypertension with heart-failureSecondary causes of hypertensionCeliac disease, inflammatory bowel disease, gastroparesis, or other gastrointestinal disorders that can flare and reduce absorption.Oligeanous (nut) allergiesReceived any intraarticular knee injections in the past month.Using topiramate, phentermine, or GLP-1 agonists (e.g., semaglutide or dulaglutide)