NCT06450860

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

May 23, 2024

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reach of Nutrition Interventions

    \# and type of referrals made based on NSAT results

    Baseline

Secondary Outcomes (4)

  • Uptake of Nutrition Interventions

    Week 1 & Week 4

  • Acceptability of Nutrition Intervention

    Week 1 & Week 4

  • Appropriateness of Nutrition Intervention

    Week 1 & Week 4

  • Satisfaction with Nutrition Intervention

    Week 4

Study Arms (1)

Nutrition Intervention

OTHER

Participants receive an individualized food provision and/or supplemental food support referral based on responses to the NSAT.

Other: Nutrition Interventions

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.

Nutrition Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 10, 2024

Study Start

May 21, 2024

Primary Completion

November 12, 2024

Study Completion

April 1, 2025

Last Updated

April 2, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations