Reducing Chronic Kidney Disease Burden in an Underserved Population
keskiviikko 25. marraskuuta 2020 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
"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).
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
142
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Texas
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Dallas, Texas, Yhdysvallat, 75210
- Baylor Research Institute
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Kokeellinen: 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
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Donald Wesson, MD, MBA, Baylor RI
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 24. tammikuuta 2019
Ensisijainen valmistuminen (Todellinen)
Lauantai 13. kesäkuuta 2020
Opintojen valmistuminen (Todellinen)
Tiistai 14. heinäkuuta 2020
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 1. helmikuuta 2019
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 4. helmikuuta 2019
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 6. helmikuuta 2019
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 27. marraskuuta 2020
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 25. marraskuuta 2020
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2020
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 1R21DK113440-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
All IPD that underlie results in a publication
IPD-jaon aikakehys
Data will be available within 6 mths of outcome publication
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ANALYTIC_CODE
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