Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers (ADMIRE)

April 10, 2025 updated by: Heather Gibbs, University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participant dyads: Caregivers and Care Recipients
Participants will be recruited in pairs as caregivers and care recipients. All data collected is observational in nature.
Participants will be examined by a registered dietitian to assess nutrition status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition status of persons with dementia
Time Frame: 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."
1 month
Nutrition literacy of caregivers
Time Frame: 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.
1 week
Nutrition status of caregivers
Time Frame: 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).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived nutrition needs of informal caregivers of persons with dementia
Time Frame: 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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heather D Gibbs, PhD, RD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Actual)

December 8, 2023

Study Completion (Actual)

December 8, 2024

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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