Nutrition Intervention Optimization to Better Utilize Resources and Support Health (NOURISH)
2026年7月14日 更新者：Tufts University
Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk.
Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs.
This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
400
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：NICHE Lab Team
- 電話番号：(469) 240-9112
- メール：niche@tufts.edu
研究場所
-
-
Texas
-
Dallas、Texas、アメリカ、75236
- Crossroads Community Services
-
コンタクト：
- NICHE Lab Team
- 電話番号：(469) 240-9112
- メール：niche@tufts.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Aged 18+,
- Body mass index (BMI)≥ 25;
- Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;
- Willingness to complete four in-person data collection appointments;
- Willing and able to consent.
Exclusion Criteria:
- Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);
- Another member of the household participating;
- Planning to move within the next 12 months;
- Unwilling to participate.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
実験的：Condition 3: Pantry, MTG, No-prep meals, and SMS
Pantry provisions, meal kits, no-prep meals, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 4: Pantry, MTG, and No-prep meals
Pantry provisions, meal kits, and no-prep meals
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
|
|
実験的：Condition 5: Pantry, MTG, Culinary classes, and SMS
Pantry provisions, meal kits, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 6: Pantry, MTG, and Culinary classes
Pantry provisions, meal kits, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
実験的：Condition 7: Pantry, MTG, and SMS
Pantry provisions, meal kits, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 8: Pantry and MTG
Pantry provisions and meal kits
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
他の名前：
|
|
実験的：Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
Pantry provisions, no-prep meals, culinary nutrition classes and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 10: Pantry, No-prep meals, and Culinary classes
Pantry provisions, no-prep meals, and culinary nutrition classes
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
実験的：Condition 11: Pantry, No-prep meals, and SMS
Pantry provisions, no-prep meals, and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 12: Pantry and No-prep meals
Pantry provisions and no-prep meals
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
他の名前：
|
|
実験的：Condition 13: Pantry, Culinary classes, and SMS
Pantry provisions, culinary nutrition classes, and text messages
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
実験的：Condition 14: Pantry and Culinary classes
Pantry provisions and culinary nutrition classes
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
実験的：Condition 15: Pantry and SMS
Pantry provisions and text messages
|
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
介入なし：Condition 16: Pantry only
Pantry provisions
|
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 |
|---|---|---|
|
Diet
時間枠：Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers.
Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish.
Will be used to calculate a Healthy Eating Index (HEI) score.
The HEI is a scale from 0 to 100.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Household food security
時間枠：Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Measured using the USDA 6-item household food security survey and will be treated as a continuous variable if normally distributed or a categorical variable if data is non-normal.
Categorical scoring will be based on USDA recommendations (0-1 affirmative responses = high or marginal food security, 2-4 = low food security, 5-6 = very low food security).
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
|
Percent body weight change
時間枠：Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be calculated as (Baseline weight minus follow-up weight) / (Baseline weight) x 100.
Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
|
Hemoglobin A1C (HbA1c)
時間枠：Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be measured using the externally validated point-of-care instrument, DCA VantageAnalyzer (1μl finger stick, nonfasting).
This method has been implemented in food pantries and is less invasive and more cost effective than a venous blood draw.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence
時間枠：Through study completion, an average of 6 months (Baseline through 6 months)
|
Number of meal kits eaten by the participant per month divided by number of meal kits selected per month, number of no-prep meals eaten per month divided by number of no-prep meals selected per month, number of culinary nutrition classes completed, and number of texts read.
|
Through study completion, an average of 6 months (Baseline through 6 months)
|
|
Implementation Outcomes
時間枠：The entirety of the participant being enrolled (6 months)
|
Will measure early-stage implementation outcomes with the follow-up questionnaire (acceptability [intervention satisfaction measures] and through administrative tracking: intervention fidelity (adherence to assigned intervention components [e.g., eating meals, attending classes, etc.] and study protocols [e.g., attending appointments]).
|
The entirety of the participant being enrolled (6 months)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kelseanna Hollis-Hansen, PhD, MPH、Tufts University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2031年2月1日
研究の完了 (推定)
2031年2月1日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月14日
最初の投稿 (実際)
2026年7月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00006929
- 1R01DK145891-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
June 2027
IPD 共有アクセス基準
The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。