Developing a Nutrition Support Assessment Tool

Food Insecurity Clinical Trial

— NSAT  

Official title:

Developing and Testing a Nutrition Support Assessment Tool - An Implementation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450860
• Other study ID #: iRISID-2022-1304
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Thomas Jefferson University
• Contact: Nina Diamond, MPH
• Phone: 267-872-1302
• Email: Nina.Diamond[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• Nutrition Assessment

Intervention

Other:
• Nutrition Interventions
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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	The MANNA Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of Nutrition Interventions	# and type of referrals made based on NSAT results	Baseline
Secondary	Uptake of Nutrition Interventions	# and type of referrals accepted and utilized by participants	Week 1 & Week 4
Secondary	Acceptability of Nutrition Intervention	Acceptability of nutrition interventions using the Acceptability of Intervention Measure (AIM)	Week 1 & Week 4
Secondary	Appropriateness of Nutrition Intervention	Appropriateness of nutrition interventions using the Intervention Appropriateness Measure (IAM)	Week 1 & Week 4
Secondary	Satisfaction with Nutrition Intervention	Self-reported satisfaction with nutrition intervention using a research-team developed assessment.	Week 4