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Living Hungry Healthy Foods Prescription Program

27 oktober 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

35

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • West Palm Beach, Florida, Förenta staterna, 33401
        • Living Hungry

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • medically tailored food

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Hemoglobin A1c
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in frequency of hospitalizations
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 december 2019

Primärt slutförande (Faktisk)

25 juli 2020

Avslutad studie (Faktisk)

13 oktober 2020

Studieregistreringsdatum

Först inskickad

16 december 2019

Först inskickad som uppfyllde QC-kriterierna

17 december 2019

Första postat (Faktisk)

19 december 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 13491

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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