Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers

Completed

• Conditions: Dementia
• Interventions: Other: Nutrition Status

• Registration Number: NCT05536830
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-13
• Study Start: 2022-10-25
• Primary Completion: 2023-12-08
• Study Completion: 2024-12-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participant dyads: Caregivers and Care Recipients	Nutrition Status	Participants will be recruited in pairs as caregivers and care recipients. All data collected is observational in nature.

Primary Outcome Measures

Name	Time	Method
Nutrition status of caregivers	1 month	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).
Nutrition literacy of caregivers	1 week	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.
Nutrition status of persons with dementia	1 month	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."

Secondary Outcome Measures

Name	Time	Method
Perceived nutrition needs of informal caregivers of persons with dementia	1 week	Researchers will use interviews, surveys, and focus groups to collect the thoughts of caregivers and clinic care providers to anticipate needs for a future caregiver intervention.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States