Healthy Eating Adherence & Routine Transformation Through a Kitchen Makeover Whole-Food, Plant-Based Diet Jumpstart (HEARTKITCHEN)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- WFPB diet acceptability
研究概览
简要总结
This study is testing a 28-day healthy eating program for adults who live in public housing and are at risk for heart disease. The program helps people eat more whole plant foods, like fruits, vegetables, beans, and whole grains, and avoid foods that are highly processed or high in fat. Participants get a "kitchen makeover," including groceries, cooking tools, whole-food, plant-based recipes, and support from a nutritionist. The goal is to see if the program is easy to follow, helpful, and if support from a spouse or partner makes it easier to stick with the new way of eating.
The study will include 24 adults who either have heart disease or are at risk because of conditions like high blood pressure, diabetes, or obesity. Researchers will visit participants at home to provide supplies and support. They will also collect surveys, interviews, and health information to learn more about how the program worked and how well participants followed the diet.
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
- •Adult public housing residents who have been diagnosed with cardiovascular disease (Individuals who have had a documented history of myocardial infarction; Individuals who have ever had a positive stress test;, Individuals who have undergone coronary artery bypass grafting surgery at any point in their life)
- •meet at least 2 of the criteria for metabolic syndrome: abdominal obesity (waist circumference of more than 35 inches for women and more than 40 inches for men or BMI = 30), high triglycerides (>150 mg/dL or drug treatment for elevated TG), low HDL cholesterol (<40 mg/dL for men and < 50 mg/dL for women or drug treatment for reduced HDL-C), high blood pressure (=130 mm Hg systolic BP, =85 mm Hg diastolic BP, or drug treatment for hypertension), high fasting blood glucose (> or = 100 mg/dL or drug treatment for elevated glucose or prediabetes/ type 2 diabetes diagnosis)
- •able to provide written informed consent
- •fluent in the English language
排除标准
- •Active cancer or chronic kidney disease diagnosis or are undergoing cancer or dialysis treatment
- •any food allergies or dietary restrictions that would prevent them from adhering to a whole-food, plant-based (WFPB) diet
- •an existing or former neurological disorder or a neuropsychiatric disorder that affects decision-making ability
- •current smoking
- •current excessive alcohol intake
- •recent history of drug abuse
- •morbid obesity (BMI > 40)
- •history of bariatric surgery
- •pregnant or lactating
- •current use of a WFPB (excludes all animal-based foods) or vegan diet
研究组 & 干预措施
Whole Food Plant Based (WFPB) Diet
28 day kitchen makeover to include initial grocery supplies, cooking equipment, recipes, and meal-prep instruction, and nutrition counseling by a licensed nutritionist, and educational support materials
干预措施: Whole Food Plant Based Diet Jumpstart (Behavioral)
结局指标
主要结局
WFPB diet acceptability
时间窗: Post- intervention (day 29)
At Day 29, participants will complete a Likert-scale survey evaluating the acceptability of the intervention, including satisfaction with meal prep, support sessions, and educational materials. Each item will be rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher average scores reflect greater acceptability.
Change in fat mass
时间窗: Baseline and week 4
Fat mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in systolic blood pressure.
时间窗: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
Change in lean mass
时间窗: Baseline and week 4
Lean mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in diastolic blood pressure.
时间窗: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
Change in adherence to the whole-food, plant-based (WFPB) diet (pre-post) based on ACLM diet screener.
时间窗: Baseline and post intervention (week 4)
Dietary intake will be assessed using the American College of Lifestyle Medicine (ACLM) Diet Screener at baseline (Day 0) and post-intervention (Day 29). This validated 15-item tool measures frequency of consumption of foods consistent with a whole-food, plant-based (WFPB) diet. Total scores range from 0 to 100, with higher scores indicating greater adherence to a WFPB diet. Change in dietary intake will be calculated by subtracting the baseline score from the post-intervention score. Positive values reflect improvement in WFPB dietary adherence.
Change in weight
时间窗: Baseline and week 4
Weightwill be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in Body Mass Index
时间窗: Baseline and week 4
BMI in kg/m\^2 based on measured weight in kg and height in meters.
Change in adherence to the whole-food, plant-based (WFPB) diet (pre-post) based on ACLM diet screener.
时间窗: Baseline and post intervention (week 4)
Dietary intake will be assessed using the American College of Lifestyle Medicine (ACLM) Diet Screener at baseline (Day 0) and post-intervention (Day 29). This validated 15-item tool measures frequency of consumption of foods consistent with a whole-food, plant-based (WFPB) diet. Total scores range from 0 to 100, with higher scores indicating greater adherence to a WFPB diet. Change in dietary intake will be calculated by subtracting the baseline score from the post-intervention score. Positive values reflect improvement in WFPB dietary adherence.
Change in weight
时间窗: Baseline and week 4
Weightwill be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in Body Mass Index
时间窗: Baseline and week 4
BMI in kg/m\^2 based on measured weight in kg and height in meters.
Change in diastolic blood pressure.
时间窗: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
Change in fat mass
时间窗: Baseline and week 4
Fat mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in systolic blood pressure.
时间窗: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
Change in lean mass
时间窗: Baseline and week 4
Lean mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
WFPB diet acceptability
时间窗: Post- intervention (day 29)
At Day 29, participants will complete a Likert-scale survey evaluating the acceptability of the intervention, including satisfaction with meal prep, support sessions, and educational materials. Each item will be rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher average scores reflect greater acceptability.
次要结局
- Qualitative Assessment of Spousal Influence on Diet Adherence (Exit Interview Coding)(Baseline, post intervention week 4)
- Difference in WFPB Diet Adherence Between Spousal Dyads and Single Individuals(Pre/Post (baseline and 4 weeks))
研究者
Reya Andrews
Principal Investigator
University of Kentucky