Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks

University of Oregon10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dementia Nutrition Poor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Medically stable * Community dwelling * Has a medical diagnosis of dementia or possible dementia Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Participant enrollment rates (%)

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)

Time frame: Measured during recruitment (at baseline, prior to study onset; week 0)

Proportion of participants deemed eligible to consume transitional-state foods

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.

Time frame: Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0)

Participant retention rates (%)

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

Time frame: Measured at the end of the study (post-intervention, after 8 weeks of snack consumption)

Change in acceptability of nutrition supplements

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)

Time frame: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)

Number of test snacks consumed each week

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)

Time frame: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)

Secondary Outcomes

Change in malnutrition status (not present, present, moderate, severe)

Malnutrition status (not present, present, moderate, severe) will be assessed via a nutrition-focused physical exam (NFPE) by a registered dietitian. The exams will be guided by the recommendations of the American Society for Parenteral and Enteral Nutrition (ASPEN) in conjunction with the Academy of Nutrition and Dietetics (AND) and use the following characteristics for diagnosing malnutrition: insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, fluid accumulation, and diminished functional status. Using published definitions of the six clinical characteristics, a diagnosis of severe malnutrition, moderate malnutrition, or not malnourished will be made.

Time frame: Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)

Change in malnutrition risk score

A malnutrition risk score will be calculated using the Mini Nutritional Assessment-Short Form (MNA-SF). Using the information collected by a registered dietitian during a nutrition-focused physical exam, the MNA-SF will be scored; the MNA-SF is a six-item, validated, and reliable screening tool for malnutrition risk.

Time frame: Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)

Change in daily energy intake (kcal/d)

Daily energy intake (in kcal/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.