Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Culturally Tailored Cooking Classes, Prescription Produce Plan.
- Who it may be relevant to
- Registry conditions: Dietary Intervention, Produce Prescription, Chronic Disease Management, Social Needs Screening. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Detailed description
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.
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Change from baseline in food security status at 12 months [Time frame: From baseline to the end of intervention at 12 months]
- Change in social needs [Time frame: During active intervention from baseline to the end of study participation at 12 months]
- Change from baseline in nutrition security status at 12 months [Time frame: From baseline to the end of intervention at 12 months]
Secondary outcome measures (10)
- Change in hemoglobin A1c from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in diet quality from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Wellness goals set and completed during active study. [Time frame: During active study engagement from baseline to end of study participation at 12 months]
- Change in global health from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in food medication trade-offs from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in healthcare utilization [Time frame: During active study participation from baseline to 12 months]
- Change in weight from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in adiposity from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in blood pressure from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
- Change in medication adherence from baseline to 12 months [Time frame: From baseline to end of study participation at 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Virginia Commonwealth University Mobile Health and Wellness Program — Richmond
Identifiers
NCT: NCT07117201 · VCU HM20032577