Reducing Chronic Kidney Disease Burden in an Underserved Population
25 de noviembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
"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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
142
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75210
- Baylor Research Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Experimental: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Donald Wesson, MD, MBA, Baylor RI
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- So BH, Methven S, Hair MD, Jardine AG, MacGregor MS. Socio-economic status influences chronic kidney disease prevalence in primary care: a community-based cross-sectional analysis. Nephrol Dial Transplant. 2015 Jun;30(6):1010-7. doi: 10.1093/ndt/gfu408. Epub 2015 Jan 13.
- Vart P, Gansevoort RT, Coresh J, Reijneveld SA, Bultmann U. Socioeconomic measures and CKD in the United States and The Netherlands. Clin J Am Soc Nephrol. 2013 Oct;8(10):1685-93. doi: 10.2215/CJN.12521212. Epub 2013 Jun 27.
- 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.
- 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.
- Wilson DK, Kitzman-Ulrich H, Resnicow K, Van Horn ML, St George SM, Siceloff ER, Alia KA, McDaniel T, Heatley V, Huffman L, Coulon S, Prinz R. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families. Contemp Clin Trials. 2015 May;42:145-57. doi: 10.1016/j.cct.2015.03.009. Epub 2015 Mar 30.
- Wilson DK, Kitzman-Ulrich H, Williams JE, Saunders R, Griffin S, Pate R, Van Horn ML, Evans A, Hutto B, Addy CL, Mixon G, Sisson SB. An overview of "The Active by Choice Today" (ACT) trial for increasing physical activity. Contemp Clin Trials. 2008 Jan;29(1):21-31. doi: 10.1016/j.cct.2007.07.001. Epub 2007 Jul 17.
- 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.
- Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.
- Bauer UE, Briss PA, Goodman RA, Bowman BA. Prevention of chronic disease in the 21st century: elimination of the leading preventable causes of premature death and disability in the USA. Lancet. 2014 Jul 5;384(9937):45-52. doi: 10.1016/S0140-6736(14)60648-6. Epub 2014 Jul 1.
- 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
- Ojo A. Addressing the global burden of chronic kidney disease through clinical and translational research. Trans Am Clin Climatol Assoc. 2014;125:229-43; discussion 243-6.
- Assari S. Distal, intermediate, and proximal mediators of racial disparities in renal disease mortality in the United States. J Nephropathol. 2016 Jan;5(1):51-9. doi: 10.15171/jnp.2016.09. Epub 2015 Dec 4.
- 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.
- Tuot DS, Peralta CA. To screen or not to screen: that is not (yet) the question. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):541-3. doi: 10.2215/CJN.02150215. Epub 2015 Mar 16. No abstract available.
- 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.
- Bibbins-Domingo K, Chertow GM, Fried LF, Odden MC, Newman AB, Kritchevsky SB, Harris TB, Satterfield S, Cummings SR, Shlipak MG. Renal function and heart failure risk in older black and white individuals: the Health, Aging, and Body Composition Study. Arch Intern Med. 2006 Jul 10;166(13):1396-402. doi: 10.1001/archinte.166.13.1396.
- Bibbins-Domingo K, Pletcher MJ, Lin F, Vittinghoff E, Gardin JM, Arynchyn A, Lewis CE, Williams OD, Hulley SB. Racial differences in incident heart failure among young adults. N Engl J Med. 2009 Mar 19;360(12):1179-90. doi: 10.1056/NEJMoa0807265.
- Gillespie BW, Morgenstern H, Hedgeman E, Tilea A, Scholz N, Shearon T, Burrows NR, Shahinian VB, Yee J, Plantinga L, Powe NR, McClellan W, Robinson B, Williams DE, Saran R. Nephrology care prior to end-stage renal disease and outcomes among new ESRD patients in the USA. Clin Kidney J. 2015 Dec;8(6):772-80. doi: 10.1093/ckj/sfv103. Epub 2015 Nov 3.
- Jenkins DJA, Boucher BA, Ashbury FD, Sloan M, Brown P, El-Sohemy A, Hanley AJ, Willett W, Paquette M, de Souza RJ, Ireland C, Kwan N, Jenkins A, Pichika SC, Kreiger N. Effect of Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factors. J Am Coll Cardiol. 2017 Mar 7;69(9):1103-1112. doi: 10.1016/j.jacc.2016.10.089.
- Thomson CA, Ravia J. A systematic review of behavioral interventions to promote intake of fruit and vegetables. J Am Diet Assoc. 2011 Oct;111(10):1523-35. doi: 10.1016/j.jada.2011.07.013. Erratum In: J Am Diet Assoc. 2012 Feb;112(2):325.
- Sharan AD, Schroeder GD, West ME, Vaccaro AR. Understanding a Value Chain in Health Care. J Spinal Disord Tech. 2015 Oct;28(8):291-3. doi: 10.1097/BSD.0000000000000319.
- Mundt L, Shanahan K. Textbook of Urinalysis and Body Fluids. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
- Ozyilmaz A, de Jong PE, Bakker SJL, Visser ST, Thio C, Gansevoort RT; PREVEND Study Group. Screening for elevated albuminuria and subsequently hypertension identifies subjects in which treatment may be warranted to prevent renal function decline. Nephrol Dial Transplant. 2017 Apr 1;32(suppl_2):ii200-ii208. doi: 10.1093/ndt/gfw414.
- Carrero JJ, Grams ME, Sang Y, Arnlov J, Gasparini A, Matsushita K, Qureshi AR, Evans M, Barany P, Lindholm B, Ballew SH, Levey AS, Gansevoort RT, Elinder CG, Coresh J. Albuminuria changes are associated with subsequent risk of end-stage renal disease and mortality. Kidney Int. 2017 Jan;91(1):244-251. doi: 10.1016/j.kint.2016.09.037. Epub 2016 Dec 4.
- Levey AS, Becker C, Inker LA. Glomerular filtration rate and albuminuria for detection and staging of acute and chronic kidney disease in adults: a systematic review. JAMA. 2015 Feb 24;313(8):837-46. doi: 10.1001/jama.2015.0602.
- Carithers TC, Talegawkar SA, Rowser ML, Henry OR, Dubbert PM, Bogle ML, Taylor HA Jr, Tucker KL. Validity and calibration of food frequency questionnaires used with African-American adults in the Jackson Heart Study. J Am Diet Assoc. 2009 Jul;109(7):1184-1193. doi: 10.1016/j.jada.2009.04.005.
- Subar AF. Developing dietary assessment tools. J Am Diet Assoc. 2004 May;104(5):769-70. doi: 10.1016/j.jada.2004.02.007. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de enero de 2019
Finalización primaria (Actual)
13 de junio de 2020
Finalización del estudio (Actual)
14 de julio de 2020
Fechas de registro del estudio
Enviado por primera vez
1 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
4 de febrero de 2019
Publicado por primera vez (Actual)
6 de febrero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
25 de noviembre de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1R21DK113440-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All IPD that underlie results in a publication
Marco de tiempo para compartir IPD
Data will be available within 6 mths of outcome publication
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre ESRD
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University of California, San FranciscoRetirado
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University of PittsburghTerminado
Ensayos clínicos sobre Fruits and Vegetables
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