Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Satisfaction with the Dietary Intervention
研究概览
简要总结
This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a diagnosis of low-risk CLL according to the modified Rai staging criteria for a minimum of 12 months and are currently undergoing observation.
- •Access to a computer or tablet and Zoom.
排除标准
- •Have active disease and are currently receiving pharmacologic treatment for CLL
- •Have previously received treatment for CLL
- •Are currently following a vegan or vegetarian diet
- •A previous or current diagnosis of disordered eating including anorexia, bulimia, binge eating disorder or avoidant/restrictive food intake disorder.
- •A diagnosis of Type 1 diabetes
- •A diagnosis of Insulin dependent type 2 diabetes
- •Currently pregnant or planning to become pregnant
结局指标
主要结局
Satisfaction with the Dietary Intervention
时间窗: 8 weeks
Subject satisfaction will be assessed post-intervention using an acceptability, appropriateness and feasibility questionnaire. The questionnaire does not use a scoring system, rather statements will be provided and participants will provide an answer ranging from "completely disagree" to "completely agree."
Adherence to the Dietary Intervention
时间窗: Up to 24 weeks
Adherence to the dietary intervention will be calculated using a dietary index developed specifically for this diet. Dietary adherence scores will be calculated using a pre- and post-intervention food frequency questionnaire, as well as 3-day food diaries obtained throughout the intervention.
Cooking Class Adherence
时间窗: 8 weeks
Cooking class attendance will also be used as a measure of adherence.
Recruitment
时间窗: Through study completion, an average of 1 year
Recruitment rate will be assessed by examining the number of potentially eligible participants, number contacted, consent rates, number completing the intervention.
Retention
时间窗: 8 weeks
Retention will be calculated using the number of participants who enroll in the study and the number of participants who complete the 8 week intervention.
次要结局
- Biomarkers of cardiometabolic health (complete metabolic panel)(Change from baseline at 4 weeks and 8 weeks.)
- Anthropometric Measures (height, weight, body mass index)(Change from baseline at 4 weeks and 8 weeks.)
- Anthropometric Measures (waist circumference)(Change from baseline at 4 weeks and 8 weeks.)
- White blood cell count(Change from baseline at 4 weeks and 8 weeks.)
- Concentration of vitamin B12(Change from baseline at 4 and 8 weeks.)
- Blood pressure(Change from baseline at 4 weeks and 8 weeks.)
- Absolute lymphocyte count(Change from baseline at 4 weeks and 8 weeks.)
- Biomarkers of cardiometabolic health (hemoglobin A1c)(Change from baseline at 4 weeks and 8 weeks.)
- Biomarkers of cardiometabolic health (cholesterol and triglycerides)(Change from baseline at 4 weeks and 8 weeks.)
- Concentration of vitamin B9(Change from baseline at 4 and 8 weeks.)
- Concentration of iron(Change from baseline at 4 and 8 weeks.)
- Concentration of ferritin(Change from baseline at 4 and 8 weeks.)
研究者
Ariel Portera
Assistant Professor Family Medicine
University of California, San Diego