Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program

Обзор

The goal of this study is to assess the feasibility to implement a prescription produce program (PPP) over 12-months within a community-based health and wellness program. The main questions it aims to answer are: a) does participation in the PPP improve participants' nutrition and food security status, health outcomes, diet quality and chronic disease management between baseline and 12 months after participating in the PPP? b) what is the cost-benefit analysis of the PPP implementation?

Подробное описание

Expanding the PPP over 12 months, incorporating additional healthy food items to increase variety, and including cooking skill sessions within the PPP will enhance participants' confidence in preventing and managing their chronic diseases. This initial assessment of the program will provide essential data for expansion and implementation. This PPP intervention will promote health equity by expanding the reach of our program and helping participants overcome SDOH, such as food insecurity, that prevent optimal diet quality and management of chronic diseases. Furthermore, continuous or more frequent monitoring of SDOH, provision of a variety of healthy food items, and lifestyle behavior change education should increase participant adherence to a more nutritious diet and medication management required for chronic disease management, and improve participants' chronic disease self-efficacy.

Вмешательства

• Поведенческое Culturally Tailored Cooking Classes
  Cooking skills session will be offered by the Delicious Legacy Program. The Delicious Legacy program is a culturally tailored, community-based nutrition and wellness intervention designed to promote health equity. Rooted in the intergenerational transmission of knowledge, the program emphasizes family socialization practices related to food, health beliefs, and caregiving. It integrates evidence-based nutritional education with ancestral foodways to address diet-related chronic illnesses while f
• Поведенческое Prescription Produce Plan
  The standard PPP includes three major parts. 1) Screening and personalized referrals/support for social needs including food, housing, health insurance and transportation by a community health worker. 2) Bi-weekly wellness visits with an MHWP team of interprofessional healthcare students, supervised by a clinical faculty, and guided by the participants' health and social needs and interests. They include education and SMART-EST goals around nutrition, physical activities, chronic disease managem

Первичные конечные точки

• Change from baseline in food security status at 12 months [Срок оценки: From baseline to the end of intervention at 12 months]
• Change in social needs [Срок оценки: During active intervention from baseline to the end of study participation at 12 months]
• Change from baseline in nutrition security status at 12 months [Срок оценки: From baseline to the end of intervention at 12 months]

Вторичные конечные точки (10)

• Change in hemoglobin A1c from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in diet quality from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Wellness goals set and completed during active study. [Срок оценки: During active study engagement from baseline to end of study participation at 12 months]
• Change in global health from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in food medication trade-offs from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in healthcare utilization [Срок оценки: During active study participation from baseline to 12 months]
• Change in weight from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in adiposity from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in blood pressure from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]
• Change in medication adherence from baseline to 12 months [Срок оценки: From baseline to end of study participation at 12 months]

Критерии участия

Критерии включения

• a participant in the Mobile Health and Wellness Program;
• an English-speaking adult aged 18 or over
• diagnosed with hypertension, high cholesterol, diabetes type 2 or pre-diabetes, arthritis, obesity, CHF, and/or COPD
• taking medication for at least one of the eligible chronic conditions listed previously.

Критерии исключения

• a prior diagnosis of dementia-related conditions: Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia
• unwilling or unable to attend at least half of the 24 team visits during the study period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Virginia Commonwealth University Mobile Health and Wellness Program — Richmond

Идентификаторы

NCT: NCT07117201 · VCU HM20032577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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