NCT04675229

Brief Summary

Older adults (≥ 55 years) who do not eat enough nutritious food are at risk of malnutrition. Malnutrition can lead to frailty, hospitalization, poor quality of life, and death. SCREEN (Seniors in the Community Risk Evaluation for Eating and Nutrition) is the leading nutrition risk screening tool for cognitively well older adults living in the community. The purpose of this study is to determine if SCREEN can be used to find nutrition risk among older adults diagnosed with mild cognitive impairment or dementia (i.e., MCI-D) or those with a MoCA \< 26 living in the community and persons living in retirement homes. SCREEN and other nutrition and health measures will be completed in 600 older adults (300 living in retirement homes with or without MCI-D, and 300 living with MCI-D in the community). SCREEN will be completed twice to determine reliability, and persons with MCI-D will have their results compared to those of a caregiver who completes it on their behalf. A dietitian's assessment and rating of nutrition risk will be used as the gold-standard to determine validity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 25, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

April 28, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

December 14, 2020

Last Update Submit

April 23, 2026

Conditions

Keywords

nutrition riskdementiaretirementvalidityreliability

Outcome Measures

Primary Outcomes (2)

  • Validity of SCREEN

    Comparison of SCREEN to a dietitian's assessment

    3 years

  • Reliability of SCREEN

    Test-retest reliability

    3 years

Eligibility Criteria

Age55 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons living with diagnosed dementia Persons with subjective complaint for memory and MoCA \< 26 Persons living in a retirement home

You may qualify if:

  • years of age or older
  • potential participants with MCI-D will have a caregiver who either lives with the participant or is in daily contact OR
  • potential participants have subjective complaint - MoCA used to confirm cogntive change OR
  • Retirement home participants will have lived in their residence for a minimum of 3 months
  • read and communicate in English
  • provide written consent or assent for persons MCI-D; caregiver written consent required if participant with cognitive change unable to provide

You may not qualify if:

  • living in a nursing home
  • do not speak or read English
  • live outside of the geographic boundaries of this study (i.e., \> 45 km from Kitchener/Waterloo or London).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heather Keller

Guelph, Ontario, Canada

Location

MeSH Terms

Conditions

MalnutritionDementia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Heather Keller

    U Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

September 25, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

April 28, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Repository at University of Waterloo

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
2025- 2035
Access Criteria
University research

Locations