- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06450860
Developing a Nutrition Support Assessment Tool (NSAT)
March 28, 2025 updated by: Thomas Jefferson University
Developing and Testing a Nutrition Support Assessment Tool - An Implementation Trial
The research team developed the Nutrition Support Assessment Tool (NSAT) that incorporates key patient life information (e.g., ability to cook, access to refrigerator/stove, medical conditions and nutritional status) to facilitate individualized nutrition referral.
The overall goal of this study is to refine and test the NSAT as a systematic approach to provide individualized nutrition needs screening and referral for patients being discharged from the acute care setting at Jefferson Health.
The investigators hypothesize the NSAT will be successful in identifying individualized nutrition referrals that are deemed acceptable and appropriate by enrolled participants.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years of age or older
- Currently admitted to Thomas Jefferson University or Methodist Hospital or Emergency Department
- Has working phone number and is willing to participate in follow-up data collection
- Eats by mouth
- Lives in MANNA's geographic service area
- Patient reports food insecurity or malnutrition using existing screening tools
Exclusion Criteria:
- Unwilling to provide consent
- Unsheltered/unhoused
- Lives in or is being discharged to facility that provides daily meals (e.g., long term care, incarcerated)
- On hospice or has life expectancy of less than 4 months, per clinician
- Not consentable
- Deaf or has other major communication barriers that compromises ability to participate in study activities
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Nutrition Intervention
Participants receive an individualized food provision and/or supplemental food support referral based on responses to the NSAT.
|
Individualized food provision and/or supplemental referral based on participant's unique needs/responses to assessment (NSAT).
Food provision interventions include medically tailored meals, home delivered prepared meals, grocery boxes, grocery delivery services, food pantries, and soup kitchens/meal sites.
Supplemental interventions include SNAP benefit enrollment support, nutrition education, and cooking education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach of Nutrition Interventions
Time Frame: Baseline
|
# and type of referrals made based on NSAT results
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of Nutrition Interventions
Time Frame: Week 1 & Week 4
|
# and type of referrals accepted and utilized by participants
|
Week 1 & Week 4
|
|
Acceptability of Nutrition Intervention
Time Frame: Week 1 & Week 4
|
Acceptability of nutrition interventions using the Acceptability of Intervention Measure (AIM)
|
Week 1 & Week 4
|
|
Appropriateness of Nutrition Intervention
Time Frame: Week 1 & Week 4
|
Appropriateness of nutrition interventions using the Intervention Appropriateness Measure (IAM)
|
Week 1 & Week 4
|
|
Satisfaction with Nutrition Intervention
Time Frame: Week 4
|
Self-reported satisfaction with nutrition intervention using a research-team developed assessment.
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 21, 2024
Primary Completion (Actual)
November 12, 2024
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
May 23, 2024
First Submitted That Met QC Criteria
June 6, 2024
First Posted (Actual)
June 10, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2025
Last Update Submitted That Met QC Criteria
March 28, 2025
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- iRISID-2022-1304
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
product manufactured in and exported from the U.S.
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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