- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03363048
Grocery Assistance Program Study for Families
9. november 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
646
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minnesota
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Minneapolis, Minnesota, Forente stater, 55454
- University of Minnesota, School of Public Health, Division of Epidemiology & Community Health
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Styre
|
|
Eksperimentell: Restricted
|
Certain foods and beverages are not allowed to be purchased with food benefit dollars.
|
Eksperimentell: Restriction plus Incentive
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
18 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total Energy Intake
Tidsramme: 18 weeks
|
18 weeks
|
Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015
Tidsramme: 18 weeks
|
18 weeks
|
Household food insecurity
Tidsramme: 18 weeks
|
18 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. mai 2018
Primær fullføring (Faktiske)
6. oktober 2019
Studiet fullført (Faktiske)
6. oktober 2019
Datoer for studieregistrering
Først innsendt
29. november 2017
Først innsendt som oppfylte QC-kriteriene
29. november 2017
Først lagt ut (Faktiske)
5. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STUDY00002037
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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