- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03363048
Grocery Assistance Program Study for Families
9. november 2020 opdateret af: University of Minnesota
Effects of Subsidies and Prohibitions on Household Nutrition in a Food Benefit Program
An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households.
Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food security questions.
The individual level measures will be collected from the adult most responsible for food shopping and a child in the household.
After baseline measures are completed households will be randomized to one of three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or 3) control (no incentive or restrictions).
Households in all conditions will be given a debit card that will have funds added monthly for a five month period.
The dollar amount placed on the card monthly will be similar to the amount the household would receive if enrolled in SNAP.
All participants will be instructed to use the debit card for food purchases only, and they'll be told they shouldn't use the card to purchase items currently non-eligible for purchase with SNAP benefits (e.g.
alcohol, food from restaurants).
Those in the restriction condition will also be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or candies.
They may purchase these foods using their own money, but not the debit card.
Those in the restriction plus incentive condition will receive the instructions provided to the restriction group plus they will be told that they'll receive a 30% bonus for fruits and vegetables purchased using their debit card.
Analyses will determine whether the nutritional quality of the diet at follow-up differs between experimental groups.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
646
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55454
- University of Minnesota, School of Public Health, Division of Epidemiology & Community Health
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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
3 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- SNAP-eligible household
- at least one child between the ages of 3-11
- Less than or equal to 6 people in the household
- Primary food shopper
- Ability and willingness to collect and submit household food purchase receipts for 22 weeks
- Willingness to attend two study visits
- willingness to complete three dietary recalls at both baseline and follow-up
- not planning to apply for SNAP in the next 5 months
- ability to speak and understand either Spanish or English
Exclusion Criteria:
- households that are not SNAP-eligible
- no children in household between the ages of 3-11
- not primary food shopper
- 7 or more people in household
- inability to collect and submit household food purchase receipts for 22 weeks
- unwillingness to comply with study measures
- inability to speak or understand Spanish or English
- planning on applying for SNAP within the next 5 months.
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: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Styring
|
|
Eksperimentel: Restricted
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Certain foods and beverages are not allowed to be purchased with food benefit dollars.
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Eksperimentel: Restriction plus Incentive
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Certain foods and beverages are not allowed to be purchased with food benefit dollars; 30% of the total dollars spent toward the purchase of certain foods result are added to their food benefit dollars.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Nutritional Quality as measured by the Healthy Eating Index (HEI)-2015 score
Tidsramme: 18 weeks
|
Overall Nutritional Quality obtained from average intake of three dietary recalls at both baseline and follow-up.
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18 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total Energy Intake
Tidsramme: 18 weeks
|
18 weeks
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Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015
Tidsramme: 18 weeks
|
18 weeks
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Household food insecurity
Tidsramme: 18 weeks
|
18 weeks
|
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)
2. maj 2018
Primær færdiggørelse (Faktiske)
6. oktober 2019
Studieafslutning (Faktiske)
6. oktober 2019
Datoer for studieregistrering
Først indsendt
29. november 2017
Først indsendt, der opfyldte QC-kriterier
29. november 2017
Først opslået (Faktiske)
5. december 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- STUDY00002037
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified data will be placed on the Open Science Framework in compliance with Laura and John Arnold Foundation (LJAF) policies.
IPD-delingstidsramme
Data will be made available upon publication of the primary outcomes manuscript and will be posted indefinitely.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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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