The Clinical Impact of Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study

NCT05735873 | Withdrawn

• 1 other identifier: U13795
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee; Hypertension; Type 2 Diabetes; Obesity

Keywords

Caloric Restriction; Low energy diet; Value-based care

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to 12 weeks

Secondary Outcomes (6)

• Change from Baseline to 12 weeks in Patient Reported Outcome Measurement Information System Physical Function10

  Baseline to 12 weeks

• Change from Baseline to 12 weeks in Knee Osteoarthritis Outcome Score Subscales

  Baseline to 12 weeks

• Change from Baseline to 12 weeks in the Western Ontario and McMasters Osteoarthritis index

  Baseline to 12 weeks

• Change from Baseline to 12 weeks in Hemoglobin A1C

  Baseline to 12 weeks

• Change from Baseline to 12 weeks in systolic blood pressure

  Baseline to 12 weeks

Study Arms (1)

Low-energy diet arm

EXPERIMENTAL

Subjects who receive low-energy premade meals for three meals each day for 12 weeks.

Other: Low-energy diet

Interventions

Low-energy diet OTHER

Twenty-one pre-made, low-energy meals delivered weekly to the subject for 12 weeks.

Low-energy diet arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Hypertension; Diabetes Mellitus, Type 2; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Model Details: Pilot study. Case series.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: November 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share