Nutrition Intervention Optimization to Better Utilize Resources and Support Health

Официальное название

Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients

Обзор

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.

Вмешательства

• Поведенческое 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).
• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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).

Первичные конечные точки

• Diet [Срок оценки: 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).]

Вторичные конечные точки (3)

• Household food security [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Crossroads Community Services — Dallas

Идентификаторы

NCT: NCT07713836 · STUDY00006929 · 1R01DK145891-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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