Food Is Medicine for Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
研究概览
简要总结
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."
详细描述
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
By the nature of the dietary intervention, it is impossible to blind participants to study arm assignment. However, research staff collecting outcome data, apart from dietary adherence data, will remain blinded to participants' assigned study arm throughout data collection. Additionally, the statistician(s) analyzing data for efficacy of the intervention will use a dataset with study arm masked in order to remain blinded to the assigned intervention for the final analysis.
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
- •Willingness to comply with all study procedures and availability for the duration of the study
- •Living in San Diego or the Bay Area of California
- •Reported congestive heart failure (CHF) diagnosis
- •Current diet can be improved
- •Willing to eat all meals provided by the study
排除标准
- •Diagnosed with end-stage heart failure
- •Diagnosed with diabetes (type 1 or uncontrolled type 2)
- •Currently taking insulin and/or meglitinides medications
- •Currently taking Glucagon-Like Peptide-1 (GLP-1) Agonists medications and not stable on a maximum maintenance dose for a minimum of 1 month
- •Hemoglobin A1c (HbA1c) results >8 %
- •Life expectancy of <1 year
- •Pregnancy or lactation
- •Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen
- •Current smoker or tobacco use within the past year
- •Planning to leave San Diego or the Bay Area during the course of the study
- •Unable to communicate reasonably well either orally or through written material in English
- •Those who, in the opinion of the investigators, cannot reliably complete the study protocol
研究组 & 干预措施
14 Medically Tailored Meals (MTM)
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
干预措施: 14 Medically Tailored Meals (MTM) per week (Other)
15 Medically Tailored Meals (MTM) + snacks
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
干预措施: 15 Medically Tailored Meals (MTM) per week (Other)
结局指标
主要结局
Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
时间窗: Baseline and Week 12
HEI will be used to determine diet quality based on dietary recall data collected via Nutrition Data System for Research (NDSR) software. HEI scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines for Americans.
次要结局
- Participant satisfaction with delivery of medically tailored meals for individuals with heart failure(Week 4 and Week 12)
- Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)(Baseline, Week 12, and Week 24)
- Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls(Baseline and Weeks 4, 6, 8, and 12)
- Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)(Baseline, Week 12, Week 24)
- Change in Hemoglobin A1C (HbA1C) levels(Baseline and Week 12)
- Change in weight(Baseline and Week 12)
- Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module(Baseline, Week 12, Week 24)
- Change in mean blood pressure(Baseline and Week 12)
- Change in blood lipid levels(Baseline and Week 12)
研究者
Cheryl A. Anderson, MPH, PhD
Professor and Dean
University of California, San Diego