Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in food security status at 12 months
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Prescription Produce Program (PPP)
The preliminary clinical effectiveness of the program on nutrition and food security status, diet quality as well as chronic disease management of individuals participating in the study
干预措施: Prescription Produce Plan (Behavioral)
Standard Prescription Produce Program (PPP) + Cooking Classes
The preliminary clinical effectiveness of the program on nutrition and food security status, diet quality as well as chronic disease management of individuals participating in the study AND cooking classes offered by Delicious Legacy.
干预措施: Prescription Produce Plan (Behavioral)
Standard Prescription Produce Program (PPP) + Cooking Classes
The preliminary clinical effectiveness of the program on nutrition and food security status, diet quality as well as chronic disease management of individuals participating in the study AND cooking classes offered by Delicious Legacy.
干预措施: Culturally Tailored Cooking Classes (Behavioral)
结局指标
主要结局
Change from baseline in food security status at 12 months
时间窗: From baseline to the end of intervention at 12 months
The Hunger Vital Sign is a validated, two-question screening tool used to identify households at risk of food insecurity. It asks if within the past 12 months, the household has "worried whether our food would run out before we got money to buy more" or if "the food we bought just didn\\'t last, and we didn\\'t have money to get more". Answering that either statement is "often true" or "sometimes true" indicates a household is at risk.
Change in social needs
时间窗: During active intervention from baseline to the end of study participation at 12 months
The Social Needs Screening short survey will be used to measure social drivers of health, including housing, food insecurity, transportation, delayed care, and financial strain. Each domain is evaluated separately. A positive response is determined for each specific category (e.g., housing, food) rather than through a cumulative score.
Change from baseline in nutrition security status at 12 months
时间窗: From baseline to the end of intervention at 12 months
1-item Brief Nutrition Security Screener, Question: In the last 12 months, (I/we) worried that the food (I was/we were) able to eat would hurt (my/our) health and well-being. Response options: Always true Often true Sometimes true Never true Don't know / Refused Interpretation Responses of "Always true," "Often true," or "Sometimes true" typically indicate a level of nutrition insecurity.
Change from baseline in food security status at 12 months
时间窗: From baseline to the end of intervention at 12 months
The Hunger Vital Sign is a validated, two-question screening tool used to identify households at risk of food insecurity. It asks if within the past 12 months, the household has "worried whether our food would run out before we got money to buy more" or if "the food we bought just didn\\'t last, and we didn\\'t have money to get more". Answering that either statement is "often true" or "sometimes true" indicates a household is at risk.
Change in social needs
时间窗: During active intervention from baseline to the end of study participation at 12 months
The Social Needs Screening short survey will be used to measure social drivers of health, including housing, food insecurity, transportation, delayed care, and financial strain. Each domain is evaluated separately. A positive response is determined for each specific category (e.g., housing, food) rather than through a cumulative score.
Change from baseline in nutrition security status at 12 months
时间窗: From baseline to the end of intervention at 12 months
1-item Brief Nutrition Security Screener, Question: In the last 12 months, (I/we) worried that the food (I was/we were) able to eat would hurt (my/our) health and well-being. Response options: Always true Often true Sometimes true Never true Don't know / Refused Interpretation Responses of "Always true," "Often true," or "Sometimes true" typically indicate a level of nutrition insecurity.
次要结局
- Change in hemoglobin A1c from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in diet quality from baseline to 12 months(From baseline to end of study participation at 12 months)
- Wellness goals set and completed during active study.(During active study engagement from baseline to end of study participation at 12 months)
- Change in global health from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in food medication trade-offs from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in healthcare utilization(During active study participation from baseline to 12 months)
- Change in weight from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in adiposity from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in blood pressure from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in medication adherence from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in food medication trade-offs from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in healthcare utilization(During active study participation from baseline to 12 months)
- Change in hemoglobin A1c from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in diet quality from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in global health from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in weight from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in adiposity from baseline to 12 months(From baseline to end of study participation at 12 months)
- Wellness goals set and completed during active study.(During active study engagement from baseline to end of study participation at 12 months)
- Change in blood pressure from baseline to 12 months(From baseline to end of study participation at 12 months)
- Change in medication adherence from baseline to 12 months(From baseline to end of study participation at 12 months)
研究者
Ana Diallo
Assistant Professor
Virginia Commonwealth University