Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers

NCT05536830 | Completed

• 1 other identifier: 148085
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nutrition is critical for disease prevention and brain health. Malnutrition and weight loss often affect persons with Alzheimer's dementia (PWD), worsening overall health and dementia. Informal caregivers (usually family members) perform many nutrition-related tasks as part of daily care such as food preparation and feeding. Limited research, however, suggests informal caregivers experience high rates of caregiver burden, malnutrition and low health literacy. More research is needed to uncover these and other factors that may contribute to malnutrition for both PWDs and their caregivers. Nutrition literacy, or ability to navigate nutrition information to select healthy food, may be an important caregiving factor that protects both individuals from experiencing nutritional decline. Although the NIH has increased funding to support caregiver research, caregiver interventions that include nutrition are lacking. The purpose of this study is to inform the design of a future nutrition intervention study.

Conditions

Dementia

Keywords

nutrition assessment

Outcome Measures

Primary Outcomes (3)

• Nutrition status of persons with dementia

  Nutrition status will be assessed by registered dietitians, using the Mini-Nutrition Assessment (score ranges 0 to 18) and Subjective Global Assessment (score ranges 0-7). Scores of each measure are further categorized into "normal," "at risk of malnutrition," or "malnourished."

  1 month

• Nutrition literacy of caregivers

  Nutrition literacy will be measured by the Nutrition Literacy Assessment Instrument (score ranges 0 to 42). Scores are interpreted as: \>39 good, 29-38: moderate, ≤ 28: poor.

  1 week

• Nutrition status of caregivers

  Nutrition status of caregivers will be measured using the Mini Nutrition Assessment (MNA) tool (18-item version). Scoring is Normal (12-14 pts), At risk of malnutrition (8-11 pts), or Malnourished (0-7 points).

  1 month

Secondary Outcomes (1)

• Perceived nutrition needs of informal caregivers of persons with dementia

  1 week

Study Arms (1)

Participant dyads: Caregivers and Care Recipients

Participants will be recruited in pairs as caregivers and care recipients. All data collected is observational in nature.

Other: Nutrition Status

Interventions

Nutrition Status OTHER

Participants will be examined by a registered dietitian to assess nutrition status.

Participant dyads: Caregivers and Care Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited as caregiver-patient dyads, and both must fit the inclusion and exclusion criteria.

You may qualify if:

• Person with dementia: Must be an adult of any age, diagnosed with Alzheimer's dementia or other dementia, reside at home with a family caregiver or domestic partner, and have weight records at a minimum of 2 timepoints.
• Caregiver: Must be at least 18 years old, English speaking, primary caregiver who is responsible for food planning, and no overt cognitive impairment.

You may not qualify if:

• Person with dementia: Frontal-temporal dementia, alcohol-related dementia, Huntington's disease, schizophrenia, manic-depressive disorder, or actively participating in nutrition intervention research.
• Caregiver: Visual impairments that prevent completing questionnaires or actively participating in nutrition intervention research.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Heather D Gibbs, PhD, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 13, 2022
• Study Start: October 25, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)