- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03832166
Reducing Chronic Kidney Disease Burden in an Underserved Population
25. november 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret 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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
142
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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Texas
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Dallas, Texas, Forenede Stater, 75210
- Baylor Research Institute
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
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Track changes in total caloric(kcal) intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Donald Wesson, MD, MBA, Baylor RI
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Goraya N, Simoni J, Jo CH, Wesson DE. A comparison of treating metabolic acidosis in CKD stage 4 hypertensive kidney disease with fruits and vegetables or sodium bicarbonate. Clin J Am Soc Nephrol. 2013 Mar;8(3):371-81. doi: 10.2215/CJN.02430312. Epub 2013 Feb 7.
- Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
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- Wilson DK, Trumpeter NN, St George SM, Coulon SM, Griffin S, Lee Van Horn M, Lawman HG, Wandersman A, Egan B, Forthofer M, Goodlett BD, Kitzman-Ulrich H, Gadson B. An overview of the "Positive Action for Today's Health" (PATH) trial for increasing walking in low income, ethnic minority communities. Contemp Clin Trials. 2010 Nov;31(6):624-33. doi: 10.1016/j.cct.2010.08.009. Epub 2010 Aug 27.
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- McClure JB. Are biomarkers useful treatment aids for promoting health behavior change? An empirical review. Am J Prev Med. 2002 Apr;22(3):200-7. doi: 10.1016/s0749-3797(01)00425-1.
- System USRD. Annual Data Report 2015: Epidemiology of Kidney Disease in the United States. Washington DC: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2015
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- Hsu CY, Lin F, Vittinghoff E, Shlipak MG. Racial differences in the progression from chronic renal insufficiency to end-stage renal disease in the United States. J Am Soc Nephrol. 2003 Nov;14(11):2902-7. doi: 10.1097/01.asn.0000091586.46532.b4.
- Freedman BI, Skorecki K. Gene-gene and gene-environment interactions in apolipoprotein L1 gene-associated nephropathy. Clin J Am Soc Nephrol. 2014 Nov 7;9(11):2006-13. doi: 10.2215/CJN.01330214. Epub 2014 Jun 5.
- Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH, Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS, Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study Investigators. APOL1 risk variants, race, and progression of chronic kidney disease. N Engl J Med. 2013 Dec 5;369(23):2183-96. doi: 10.1056/NEJMoa1310345. Epub 2013 Nov 9.
- Navaneethan SD, Schold JD, Arrigain S, Jolly SE, Nally JV Jr. Cause-Specific Deaths in Non-Dialysis-Dependent CKD. J Am Soc Nephrol. 2015 Oct;26(10):2512-20. doi: 10.1681/ASN.2014101034. Epub 2015 Jun 4.
- Honeycutt AA, Segel JE, Zhuo X, Hoerger TJ, Imai K, Williams D. Medical costs of CKD in the Medicare population. J Am Soc Nephrol. 2013 Sep;24(9):1478-83. doi: 10.1681/ASN.2012040392. Epub 2013 Aug 1.
- Vart P, Reijneveld SA, Bultmann U, Gansevoort RT. Added value of screening for CKD among the elderly or persons with low socioeconomic status. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):562-70. doi: 10.2215/CJN.09030914. Epub 2015 Mar 16.
- 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.
- Kangovi S, Barg FK, Carter T, Long JA, Shannon R, Grande D. Understanding why patients of low socioeconomic status prefer hospitals over ambulatory care. Health Aff (Millwood). 2013 Jul;32(7):1196-203. doi: 10.1377/hlthaff.2012.0825.
- Hoy WE, Wang Z, Baker PR, Kelly AM. Reduction in natural death and renal failure from a systematic screening and treatment program in an Australian Aboriginal community. Kidney Int Suppl. 2003 Feb;(83):S66-73. doi: 10.1046/j.1523-1755.63.s83.14.x.
- Record NB, Onion DK, Prior RE, Dixon DC, Record SS, Fowler FL, Cayer GR, Amos CI, Pearson TA. Community-wide cardiovascular disease prevention programs and health outcomes in a rural county, 1970-2010. JAMA. 2015 Jan 13;313(2):147-55. doi: 10.1001/jama.2014.16969. Erratum In: JAMA. 2015 Jun 2;313(21):2185.
- 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.
- Hoerger TJ, Wittenborn JS, Zhuo X, Pavkov ME, Burrows NR, Eggers P, Jordan R, Saydah S, Williams DE. Cost-effectiveness of screening for microalbuminuria among African Americans. J Am Soc Nephrol. 2012 Dec;23(12):2035-41. doi: 10.1681/ASN.2012040347.
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- Vargas RB, Norris KC. Kidney disease progression and screening cost-effectiveness among African Americans. J Am Soc Nephrol. 2012 Dec;23(12):1915-6. doi: 10.1681/ASN.2012101028. Epub 2012 Nov 15. No abstract available.
- Maziarz M, Black RA, Fong CT, Himmelfarb J, Chertow GM, Hall YN. Evaluating risk of ESRD in the urban poor. J Am Soc Nephrol. 2015 Jun;26(6):1434-42. doi: 10.1681/ASN.2014060546. Epub 2014 Dec 4.
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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)
24. januar 2019
Primær færdiggørelse (Faktiske)
13. juni 2020
Studieafslutning (Faktiske)
14. juli 2020
Datoer for studieregistrering
Først indsendt
1. februar 2019
Først indsendt, der opfyldte QC-kriterier
4. februar 2019
Først opslået (Faktiske)
6. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. november 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1R21DK113440-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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 Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- 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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Kliniske forsøg med Fruits and Vegetables
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