Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Feasibility: Retention Rate
研究概览
简要总结
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention.
详细描述
This is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older AA (n=30). Specifically, this study aims to evaluate the feasibility and acceptability of the brain healthy soul food diet intervention. As secondary outcomes, this study aims to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older AA to form the basis of estimating power and sample size for a future full-scale randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identify as African American or Black
- •Age 55 and older
- •English Proficient
- •1 or more of the following CVD risk factors (high blood pressure, high cholesterol, overweight/obesity with a BMI of 25 or more)
- •Cognitively Normal with an AD8 <2 (normal cognition)
排除标准
- •No CVD risk factors
- •AD8 equal to or greater than 2
- •Existing diet plan prescribed by a clinician
- •Non menopausal (because of DXA scan)
- •No internet connection
- •Uncontrolled hypertension, by history, or as indicated by supine systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg at the baseline visit. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension
- •Neurological diseases that impact cognition
- •Other medical conditions likely to be negatively impacted by a diet change or that could confound the study data
- •Unable or unwilling to provide written consent
- •PI determination that study is unsafe or unsuitable
- •Active depression as determined by a score of 5 or above on the PHQ9 and deemed to be clinically significant by the medical monitor
结局指标
主要结局
Feasibility: Retention Rate
时间窗: 12 weeks
Feasibility will be assessed by retention rate. This will be calculated as the percentage of participants who complete all aspects of the intervention including cooking classes and coach directed dietary call support.
次要结局
- Acceptability(Acceptability assessment will be conducted at the 12-week mark.)
- Body Mass Index(Assessed at baseline and 12 weeks; 12-week data reported)
- Total Fat Mass(Assessed at baseline and 12 weeks; 12-week data reported)
- Android Fat Mass(Assessed at baseline and 12 weeks; 12-week data reported)
- Waist Circumference(Assessed at baseline and 12 weeks; 12-week data reported)
- Systolic Blood Pressure(All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.)
- Total Cholesterol(All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.)
- Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter)(Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.)
- Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener)(Self-reported dietary intake was assessed at baseline and at the 12-week follow-up)
- Cognitive Function(Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.)
- Feasibility: Reasons for Refusal(Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.)
- Satisfaction - Visual Analog Scale(Satisfaction assessment will be conducted at the 12-week mark.)
- Acceptability(Acceptability assessment will be conducted at the 12-week mark.)