Nutrition AssessmentNSATNCT06450860
Developing a Nutrition Support Assessment Tool
A study testing Nutrition Interventions in people with Nutrition Assessment and Food Insecurity, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Assessment, Food Insecurity
- What is being tested?
- Nutrition Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
- Conditions
- Nutrition Assessment, Food Insecurity
- Being tested
- Nutrition Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition InterventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Intervention | Other | Participants receive an individualized food provision and/or supplemental food support referral based on responses to the NSAT. Receives: Other: Nutrition Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of Nutrition Interventions
# and type of referrals made based on NSAT results
Measured: Baseline
Secondary outcomes (4)
Uptake of Nutrition Interventions
# and type of referrals accepted and utilized by participants
Measured: Week 1 & Week 4
Acceptability of Nutrition Intervention
Acceptability of nutrition interventions using the Acceptability of Intervention Measure (AIM)
Measured: Week 1 & Week 4
Appropriateness of Nutrition Intervention
Appropriateness of nutrition interventions using the Intervention Appropriateness Measure (IAM)
Measured: Week 1 & Week 4
Satisfaction with Nutrition Intervention
Self-reported satisfaction with nutrition intervention using a research-team developed assessment.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start21 May 2024
- Primary completion12 Nov 2024
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- The MANNA Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450860
- Sponsor's protocol ID
- iRISID-2022-1304
- Acronym
- NSAT
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Nutrition Support Assessment Tool - An Implementation Trial
- ClinicalTrials.gov ID
- NCT06450860
- Acronym / sponsor ID
- NSAT / iRISID-2022-1304
- Conditions
- Nutrition Assessment, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- The MANNA Institute
- Study start
- 21 May 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention | Other | Other: Nutrition InterventionsParticipants receive an individualized food provision and/or supplemental food support referral based on responses to the NSAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition InterventionsIndividualized 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. | Other | Nutrition Intervention |
Primary outcome
Reach of Nutrition Interventions
Time frame: Baseline
# and type of referrals made based on NSAT results
4 secondary outcomes
Uptake of Nutrition Interventions
Time frame: Week 1 & Week 4
Acceptability of Nutrition Intervention
Time frame: Week 1 & Week 4
Appropriateness of Nutrition Intervention
Time frame: Week 1 & Week 4
Satisfaction with Nutrition Intervention
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Interventions in people with Nutrition Assessment and Food Insecurity, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of Nutrition Interventions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.