Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Proportion of participants deemed eligible to consume transitional-state foods
研究概览
简要总结
Malnutrition significantly contributes to the disability and mortality associated with Alzheimer's disease and Alzheimer's disease-related dementias. Thus, nutritional status is one important, modifiable clinical factor for maintaining physical and cognitive health among persons with dementia (PWD). This project will pilot an innovative approach to enhancing nutrition through the use of transitional-state snack supplements, or foods that start as one texture and change to another.
Specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement among adults with dementia. The central hypothesis is that access to ready-made, savory, nutrient- dense snack supplements that resemble "typical" preferred foods and eating habits will result in improved nutritional intake and status among PWD.
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
- •Medically stable
- •Community dwelling
- •Has a medical diagnosis of dementia or possible dementia
排除标准
- •Does not live at home
- •Cannot participate in the protocol independently and do not have a consistent caregiver who can provide assistance
- •Does not have smartphone access
- •Requires 100% feeding assistance
- •Is NPO (nil per os)
- •Has multiple food allergies
- •Requires a strict renal, low-fat, and/or no-salt diet
- •Is deemed unsafe for the transitional-state foods by a speech-language pathologist
结局指标
主要结局
Proportion of participants deemed eligible to consume transitional-state foods
时间窗: Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0)
Instrumental swallowing assessments will be conducted for each participant by a licensed speech-language pathologist to determine whether the potential participant can safely consume transitional-state foods based on their swallowing physiology. The number of potential participants deemed eligible to consume this consistency of food will be compared to the total number of potential participants receiving the swallow study.
Number of test snacks consumed each week
时间窗: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)
As a measured of adherence to the protocol, participants will document the total number of test snacks consumed each week (protocol is for at least one snack per day)
Participant retention rates (%)
时间窗: Measured at the end of the study (post-intervention, after 8 weeks of snack consumption)
The percentage of participants retained (i.e., who who remain enrolled and participate for the duration of the study) as compared to the total number of participants who are enrolled
Change in acceptability of nutrition supplements
时间窗: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)
Using a Likert (5 point) rating scale, participants will rate their acceptability of the nutrition supplements each week. Change in acceptability will be calculated over the length of the study (e.g., increased or decreased acceptability over time)
Participant enrollment rates (%)
时间窗: Measured during recruitment (at baseline, prior to study onset; week 0)
The percentage of participants enrolled (i.e., who meet all eligibility criteria) as compared to the total number of participants who are recruited (i.e., initiate contact with the research team)
次要结局
- Change in protein intake (g/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))
- Change in malnutrition risk score(Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption))
- Change in carbohydrate intake (g/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))
- Change in calcium intake (mg/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))
- Change in fat intake (g/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))
- Change in malnutrition status (not present, present, moderate, severe)(Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption))
- Change in daily energy intake (kcal/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))
- Change in vitamin D intake (mg/d)(Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption))