Reducing Chronic Kidney Disease Burden in an Underserved Population
25. november 2020 oppdatert av: Baylor Research Institute
A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems.
This novel study will evaluate the feasibility and preliminary efficacy of providing F&V to individuals identified at high risk study for CKD and ESRD through community health screenings.
Further, it will evaluate whether providing education as to how to prepare F&V for consumption, the latter being done for all F&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years).
Participants will be randomized to a 1) F&V only (F&V Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).
Studietype
Intervensjonell
Registrering (Faktiske)
142
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Dallas, Texas, Forente stater, 75210
- Baylor Research Institute
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Willingness to participate in 6 month F&V study
- Positive urine dipstick.
- African American (self declared) race
- Access to internet via personal computer or mobile device
- Ability to read and write in English
Exclusion Criteria:
- Negative urine dipstick
- Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
- Have received or need kidney transplant
- Pregnant or plan to become pregnant in the next 6 months
- Baseline urine potassium > 60 mEq/g creatinine
- Nephrotic proteinuria demonstrated on urine ACR measurement
- Lacking access to the internet via personal computer or mobile device
- Unable to read or write in English
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Fruits and Vegetables Only
This group will receive a prescribed amount of free fruits and vegetables (F & V) for 6 weeks through pick-up at a farm stand, or direct delivery.
After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 18 weeks with minimal contact
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Fruits and vegetables delivery, once/week for 24 weeks
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Eksperimentell: Fruits and Vegetables and Cook
In addition to the prescribed amount of free F&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum.
Participants will also receive free ingredients to complete the recipe from each weekly session at home.
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Fruits and vegetables delivery, once/week for 24 weeks
Nutrition education and cooking instruction class, one class/week for 6 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Primary surrogate marker of eGFR
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Baseline; 6 weeks; 6 months
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Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure of renal damage
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Baseline; 6 weeks; 6 months
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Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Track changes in fruit and vegetable intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
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Changes from baseline in dietary fat intake at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Track changes in fat (g) intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
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Changes from baseline in caloric intake at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
|
Track changes in total caloric(kcal) intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)
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Baseline; 6 weeks; 6 months
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Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
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Baseline; 6 weeks; 6 months
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Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk
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Baseline; 6 weeks; 6 months
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Changes from baseline in Blood glucose at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk
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Baseline; 6 weeks; 6 months
|
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Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
Tidsramme: Baseline; 6 weeks; 6 months
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Measure body mass index(lb/inches squared) to assess CVD risk
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Baseline; 6 weeks; 6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Donald Wesson, MD, MBA, Baylor RI
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
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- Kurella-Tamura M, Goldstein BA, Hall YN, Mitani AA, Winkelmayer WC. State medicaid coverage, ESRD incidence, and access to care. J Am Soc Nephrol. 2014 Jun;25(6):1321-9. doi: 10.1681/ASN.2013060658. Epub 2014 Mar 20.
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- Crews DC, Boulware LE, Gansevoort RT, Jaar BG. Albuminuria: is it time to screen the general population? Adv Chronic Kidney Dis. 2011 Jul;18(4):249-57. doi: 10.1053/j.ackd.2011.06.004.
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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)
24. januar 2019
Primær fullføring (Faktiske)
13. juni 2020
Studiet fullført (Faktiske)
14. juli 2020
Datoer for studieregistrering
Først innsendt
1. februar 2019
Først innsendt som oppfylte QC-kriteriene
4. februar 2019
Først lagt ut (Faktiske)
6. februar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. november 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1R21DK113440-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All IPD that underlie results in a publication
IPD-delingstidsramme
Data will be available within 6 mths of outcome publication
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- 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. .