Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program
- Conditions
- Dietary InterventionProduce PrescriptionChronic Disease ManagementSocial Needs Screening
- Registration Number
- NCT07117201
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
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 food items to increase the variety of healthy food items and cooking skill sessions within 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 prevents 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 healthier diet and medication management required for chronic disease management, improve participants' chronic disease self-efficacy.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in food security status at 12 months From baseline to the end of intervention at 12 months 2-item Hunger Vital Sign
Change in social needs 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, delay care, financial strain.
Change from baseline in nutrition security status at 12 months From baseline to the end of intervention at 12 months 1-item Brief Nutrition Security Screener
- Secondary Outcome Measures
Name Time Method Change in weight from baseline to 12 months From baseline to end of study participation at 12 months Body weight measured using a calibrated digital scale
Change in adiposity from baseline to 12 months From baseline to end of study participation at 12 months Adiposity which will be measured by waist circumference using the National Health and Nutrition Examination Survey protocol
Change in blood pressure from baseline to 12 months From baseline to end of study participation at 12 months Blood pressure (SBP/DBP) measured by the Omron Hem 705 CP Auto Inflate BP Monitor
Change in hemoglobin A1c from baseline to 12 months From baseline to end of study participation at 12 months Blood glucose level measured by hemoglobin A1c (HbA1c) levels using the DCA Vantage® Analyzer for individuals with diabetes and pre-diabetes
Change in global health from baseline to 12 months From baseline to end of study participation at 12 months the PROMIS Global Health includes global perceptions of general health that cut across physical and mental domains. The measure will assess the potential impact of the PPP on participants' overall health and chronic disease management.
Change in diet quality from baseline to 12 months From baseline to end of study participation at 12 months a) Dietary quality measured as the Healthy Eating Index using the DietID™, an assessment tool capturing dietary intake through an innovative Diet Quality Photo Navigation (DQPN®) software
Wellness goals set and completed during active study. During active study engagement from baseline to end of study participation at 12 months Participants set a study-specific wellness goal related to lifestyle behaviors and chronic disease management at study baseline. Wellness goals are categorized by type of activity (e.g., physical activity, vegetable intake). During the MHWP team visits, participants will be supported to identify and design health and lifestyle behavior goals which will be SMART- EST (Specific, Measurable, Achievable, Relevant, Time-bound, Evidence-based, Strategic and Tailored). Participants provide progress updates and work towards optional action steps during visits through qualitative responses. Participants report if they achieved their wellness goal at study endpoint.
Change in healthcare utilization During active study participation from baseline to 12 months Self-reported healthcare utilization during team visits to include: last time seen at PCP, any hospitalizations or ER visits since last PPP visit or within the last month, # hospital and ER visits in last month, reasons for hospital and ER visits assessed during team visits. No standardized tool will be used.
Change in medication adherence from baseline to 12 months From baseline to end of study participation at 12 months Medication adherence will be measured using the Adherence to Refills and Medications Scale (ARMS) which assesses adherence with the filling or refilling of prescriptions, and adherence with taking medications. ARMS include 14 items on a Likert scale with "none," "some," "most," or "all" of the time.
Change in food medication trade-offs from baseline to 12 months From baseline to end of study participation at 12 months Food/medication trade-offs which will assess trade-offs between food and medications or diabetes supplies if they reported having a diagnosis of type 2 diabetes. We will use the following four Likert-scale questionnaire (Ippolito et al., 2017) with response on 'often', 'sometimes', 'rarely' or 'never' to answer: "How often have you...:(1) put off buying food so that you would have money to buy medicines? (2) put off buying medicines so that you would have money to buy food? (3) put off buying diabetes supplies, like test strips or lancets, so that you would have money to buy food? (4) put off buying food so that you would have money to buy diabetes supplies, like test strips or lancets