Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Quality of Life-Lite survey
研究概览
简要总结
This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.
详细描述
To optimize care for overweight/obese patients who are awaiting kidney transplants by implementing a referral process and a multi-pronged, team-based nurse/pharmacist/dietitian weight loss treatment intervention to help these patients achieve transplant criteria. Obesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function. Effective January 5, 2023, the Organ Procurement and Transplantation Network Board of Directors requires use of a race-neutral estimated glomerular filtration rate (eGFR) to qualify candidates for kidney transplant. They also required transplant programs to identify Black candidates who may have been wrongly denied qualification
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
盲法说明
This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on the waiting list for kidney transplant at VCUHS
- •BMI greater than 35 kg/m2
排除标准
- •Children, prisoners, pregnant women
研究组 & 干预措施
Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.
This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) the use of medications for weight loss, (2) patient education using a proven weight loss curriculum, and (3) technology tools for making healthy lifestyle choices.
干预措施: Lifestyle tools for weight loss (Behavioral)
Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.
This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) the use of medications for weight loss, (2) patient education using a proven weight loss curriculum, and (3) technology tools for making healthy lifestyle choices.
干预措施: Education regarding Weight loss (Behavioral)
Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.
This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) the use of medications for weight loss, (2) patient education using a proven weight loss curriculum, and (3) technology tools for making healthy lifestyle choices.
干预措施: Blood draw (Biological)
结局指标
主要结局
Quality of Life-Lite survey
时间窗: Only completed at baseline and week 40
Impact of Weight on Quality of Life-Lite (IWQOL-Lite©) Screening. IWQOL-Lite© is a validated, 31-item, self-report measure of obesity-specific quality of life in adults. The scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis. In addition to a total score, there are scores on five domains: Physical function (11 items) Self-esteem (7 items) Sexual life (4 items) Public distress (5 items) Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life.
Meal recall survey
时间窗: completed at weeks 1, 4, 8, 12, 20 and 28
A meal recall survey, also known as a 24-hour dietary recall, is a structured interview that asks a person to recall what they ate and drank in the previous 24 hours. The goal is to gather detailed information about a person's diet, including portion sizes, cooking methods, and time of consumption. This information can be used to identify dietary patterns, assess nutrient intake, and develop nutrition recommendations
PrevenT2 education T
时间窗: Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36
A program from the National Diabetes Prevention Program that helps people with prediabetes to change their risk of developing type 2 diabetes using a CDC-approved curriculum. The PreventT2 program can help people with prediabetes cut their risk of developing type 2 diabetes in half. T
次要结局
未报告次要终点