The Clinical Impact of a Low-energy Diet on Medical Conditions Treated Within Bundled Payment Models: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 5
- 主要终点
- Change from Baseline to 12 weeks in Numeric Pain Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change from Baseline to 12 weeks in Numeric Pain Rating Scale
时间窗: 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).
次要结局
- 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 Patient Reported Outcome Measurement Information System Physical Function10(Baseline to 12 weeks)
- Change from Baseline to 12 weeks in diastolic blood pressure(Baseline to 12 weeks)
- Change from Baseline to 12 weeks in systolic blood pressure(Baseline to 12 weeks)
研究者
Leon Scott
Assistant Professor of Orthopaedic Surgery
Vanderbilt University Medical Center