Living Hungry Healthy Foods Prescription Program
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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West Palm Beach、Florida、アメリカ、33401
- Living Hungry
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
- Diabetic with A1C over 8.0
- Adults 18 years of age or older
- Food-insecure
Exclusion Criteria:
- Referred patients with HbA1c levels below 8.0 mmol/mol
- Minors
- Adults with severe mental illness who cannot provide informed consent, unless they have present a lawful caregiver or power of attorney.
- Anyone who does not plan on staying in West Palm Beach for the next 4 months.
- Pregnant women (can still receive services through the program but will not be included in the analysis)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Healthy Food Prescription
Participants receive services through the Living Hungry program for food insecure diabetic patients.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Hemoglobin A1c
時間枠：pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
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will be measured by blood draws at first and last program event
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pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in frequency of hospitalizations
時間枠：pre/post change in hospitalizations in participants from baseline to one month after completion of the program
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will be measured through surveys and data from electronic medical records
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pre/post change in hospitalizations in participants from baseline to one month after completion of the program
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Change in frequency of emergency department admissions
時間枠：pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
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will be measured through surveys and data from electronic medical records
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pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
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Change in total health care costs
時間枠：pre/post change in total health care costs in participants from baseline to one month after completion of the program
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will be measured through data from hospital records
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pre/post change in total health care costs in participants from baseline to one month after completion of the program
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Change in food insecurity
時間枠：pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
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Food insecurity will be measured using the USDA 9-question food insecurity screener
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pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
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Change in daily servings of fruits and vegetables
時間枠：pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
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Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
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pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
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Change in daily servings of whole grains
時間枠：pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
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Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
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pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
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Change in daily servings of lean proteins
時間枠：pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
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Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: nuts, seeds, legumes, poultry, and fish.
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pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
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Change in daily servings of sugary snacks and drinks
時間枠：pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
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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
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pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
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Change in medication adherence
時間枠：pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
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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.
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pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
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Change in adhering to recommended diabetes management plan
時間枠：pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
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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.
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pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
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Change in blood LDL level
時間枠：pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
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measured at first and last program event through a blood draw
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pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
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Change in systolic blood pressure
時間枠：pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
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measured at first and last program event
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pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
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Change in diastolic blood pressure
時間枠：pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
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measured at first and last program event
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pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Dariush Mozaffarian, MD, DrPH、Tufts University Friedman School of Nutrition Science and Policy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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