- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03421106
A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity (SuperShelf)
11. maj 2022 opdateret af: Caitlin Caspi, University of Connecticut
The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries.
We will enroll a sample clients at the food pantry at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome) and cardiovascular health.
We will also enroll a sample of clients at follow-up to assess to assess the nutritional quality of food selected at the pantry.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Evaluate the health impact of an intervention targeting the hunger relief network and the clients with food insecurity it serves.
The long-term goal of this work is to reduce nutrition-related health disparities by intervening on a system that serves individuals at high risk for chronic disease.
In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to enough food for an active, healthy life for all household members).
Large numbers of low-income, racial/ethnic minority, and immigrant families who experience food insecurity rely on a hunger relief network that includes food banks and food pantries.
Pantry clients have demonstrated poor nutritional outcomes, high chronic disease rates, and dissatisfaction with the quality and cultural-appropriateness of food offered.
Unlike other food assistance programs, there are currently no standards on the nutritional quality of pantry offerings, but recent work by our study team demonstrated the need to improve the healthfulness of hunger relief network inventory.
We proposed an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries.
We will enroll clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome).
Working with our food bank partners, the intervention at the pantry level targets the supply of nutritious foods.
At the client level, the intervention targets healthy food demand.
Measured outcomes include overall diet quality (the primary outcome), as assessed by the Healthy Eating Index-2015 (HEI), the nutritional quality of foods selected at the food shelf visit, and cardiovascular disease health (assessed by the American Heart Association's Life's Simple 7 scores).
The study will also evaluate the impact of a multilevel intervention on the nutritional quality of pantry offerings.
The study also aims to improve implementation of practices that promote a nutrition-focused hunger relief network.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
504
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55414
- University of Minnesota
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-≥18 years old
- Mentally capable of consent and participation
- Speak English, Spanish, or Somali
- Have access to a phone
Exclusion Criteria:
- Not capable of consent or participation
- Speak only languages other than English, Spanish or Somali
- Not a food pantry user
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: FOREBYGGELSE
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
EKSPERIMENTEL: Intervention Food Pantries
Food pantries will transform to offer healthier and more appealing food ; the effect on clients will be measured.
|
Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.
|
|
ACTIVE_COMPARATOR: Control Food Pantries
Food pantries will make no changes during the evaluation period; the effect on clients will be measured.
|
Normal food pantry use
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Diet Quality of Clients
Tidsramme: Baseline, 1 year
|
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
|
Baseline, 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Nutritional Quality of Food Selected by Clients at the Food Pantry
Tidsramme: 1 års sammenligning efter prøven
|
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
|
1 års sammenligning efter prøven
|
|
Cardiovascular Health
Tidsramme: Baseline, 1 year
|
American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health
|
Baseline, 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (FAKTISKE)
5. februar 2018
Primær færdiggørelse (FAKTISKE)
1. september 2019
Studieafslutning (FAKTISKE)
16. november 2020
Datoer for studieregistrering
Først indsendt
29. januar 2018
Først indsendt, der opfyldte QC-kriterier
29. januar 2018
Først opslået (FAKTISKE)
5. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
9. februar 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- H20-0076
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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