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Living Hungry Healthy Foods Prescription Program

2020. október 27. frissítette: Dariush Mozaffarian, Tufts University
This study is a pre/post, pilot evaluation of the 4-month, Living Hungry program for food-insecure patients with uncontrolled diabetes. The program provides free produce, whole grains and legumes to participants and their household every-other week, in addition, to nutrition education and glucose monitoring devices. The study is analyzing diabetes management indicators, including HbA1c, dietary quality, food insecurity, and medication adherence, plus health care utilization.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Részletes leírás

The Living Hungry Collaborative, in partnership with the South Florida Hunger Coalition, previously operated a pilot program, Fresh Food Farmacy, staged from June 1, 2018, to September 29, 2018. The program consisted of nine Eat Well Pop-Up Pantry events at the My Clinic in Jupiter, Florida, serving 104 patients and feeding approximately 300 people including their families. Each set of groceries contained two weeks' worth of "medically tailored" groceries for diabetic-friendly meals for food-insecure patients diagnosed with diabetes or prediabetes. All clients involved in the intervention were referred by staff at the same four clinics that will participate in this study: My Clinic, C.L. Brumback Clinic in Jupiter, Jupiter Medical Center, and FoundCare. The Living Hungry Collaborative has an ongoing program to further evolve and test the "Fresh Food Farmacy", renamed as the Healthy Food Prescription Program intervention in Palm Beach County, for food-insecure, diabetic patients.

In addition to receiving diabetic appropriate groceries at the former Fresh Food Farmacy events, clients will be engaged in diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by nutritionists and dietitians on best choices from a menu for diabetics, and tasting new recipes with produce from the pop-up event. The pilot program allowed Living Hungry to fine-tune the patient referral process, distribution logistics, and establish strong partnerships required for the next phase of the program. However, gaps exist to understand the extent to which the program design is improving the health of the participating diabetic patients.

Living Hungry will partner with Tufts University to conduct an evaluation of this existing program on key health outcomes that concern the partner clinics, specifically: biomarkers including Hemoglobin A1C, BMI, blood pressure, lipid profile, health care utilization including medication use, hospitalizations, emergency department visits, and health care costs, plus dietary quality, food insecurity, medication use, and quality of life indicators. The study is a pilot evaluation, implementing a quasi-experimental, pre/post study design.

The Living Hungry Healthy Foods Prescription Program is a community-based program that will be available to individuals whether or not they participate in the evaluation by Tufts University. This program is using the same referral and data collections procedures as the pilot, which include having physicians at the partner clinics refer patients with HbA1C levels greater than 8.0 mmol/mol and who are food insecure to Living Hungry to participate in the program. In addition, Living Hungry will again collect data on HbA1c, BMI, blood pressure, lipid profiles, and distribute a survey to participants.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

35

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • Florida
      • West Palm Beach, Florida, Egyesült Államok, 33401
        • Living Hungry

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  1. Referred patient from one of four medical partners: My Clinic, C.L. Brumback Clinic, FoundCare and Jupiter Medical Center and has been a patient for at least one-year.
  2. Diabetic with A1C over 8.0
  3. Adults 18 years of age or older
  4. Food-insecure

Exclusion Criteria:

  1. Referred patients with HbA1c levels below 8.0 mmol/mol
  2. Minors
  3. Adults with severe mental illness who cannot provide informed consent, unless they have present a lawful caregiver or power of attorney.
  4. Anyone who does not plan on staying in West Palm Beach for the next 4 months.
  5. Pregnant women (can still receive services through the program but will not be included in the analysis)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Támogató gondoskodás
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Healthy Food Prescription
Participants receive services through the Living Hungry program for food insecure diabetic patients.
Participants will receive diabetic appropriate groceries, diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by dietitians.
Más nevek:
  • medically tailored food

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Hemoglobin A1c
Időkeret: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
will be measured by blood draws at first and last program event
pre/post change in HbA1c in participants from baseline to completion of the program at 4 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in frequency of hospitalizations
Időkeret: pre/post change in hospitalizations in participants from baseline to one month after completion of the program
will be measured through surveys and data from electronic medical records
pre/post change in hospitalizations in participants from baseline to one month after completion of the program
Change in frequency of emergency department admissions
Időkeret: pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
will be measured through surveys and data from electronic medical records
pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
Change in total health care costs
Időkeret: pre/post change in total health care costs in participants from baseline to one month after completion of the program
will be measured through data from hospital records
pre/post change in total health care costs in participants from baseline to one month after completion of the program
Change in food insecurity
Időkeret: pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
Food insecurity will be measured using the USDA 9-question food insecurity screener
pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
Change in daily servings of fruits and vegetables
Időkeret: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Change in daily servings of whole grains
Időkeret: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
Change in daily servings of lean proteins
Időkeret: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: nuts, seeds, legumes, poultry, and fish.
pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
Change in daily servings of sugary snacks and drinks
Időkeret: pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: sugar sweetened beverages, pastries, cookies, cakes, candy, and other sweets
pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
Change in medication adherence
Időkeret: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
Measured as a composite score that will be assessed through a survey. Components include: frequency of sacrificing medication purchases for other household needs (such as food, utilities) and change in medication use.
pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
Change in adhering to recommended diabetes management plan
Időkeret: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Measured as a composite scale that will be assessed through a survey. Components include frequency in which participants followed the recommendations of their physicians to manage their diabetes.
pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Change in blood LDL level
Időkeret: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
measured at first and last program event through a blood draw
pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
Change in systolic blood pressure
Időkeret: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
measured at first and last program event
pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
Change in diastolic blood pressure
Időkeret: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
measured at first and last program event
pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Nyomozók

  • Kutatásvezető: Dariush Mozaffarian, MD, DrPH, Tufts University Friedman School of Nutrition Science and Policy

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2019. december 14.

Elsődleges befejezés (Tényleges)

2020. július 25.

A tanulmány befejezése (Tényleges)

2020. október 13.

Tanulmányi regisztráció dátumai

Először benyújtva

2019. december 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2019. december 17.

Első közzététel (Tényleges)

2019. december 19.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. október 28.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. október 27.

Utolsó ellenőrzés

2020. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 13491

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

Nem

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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Klinikai vizsgálatok a Diabetes mellitus

3
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