Fruit and Vegetable Rx (FVRx) + Home Plate
- Conditions
- Food Insecurity
- Interventions
- Other: Virtual Home PlateOther: Home Plate LiteOther: Fruit and Vegetable prescription
- Registration Number
- NCT04986046
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.
- Detailed Description
The purpose of this research study is to determine the effect of produce prescriptions (vouchers that can be redeemed for produce at participating locations, "FVRx") and a cooking skills program (Home Plate) on dietary quality, food security, perceptions of the food environment, and mental health. Investigators also aim to determine the feasibility and acceptability of the programs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fruit and vegetable prescription + Virtual Home Plate Fruit and Vegetable prescription Fruit and vegetable incentive program + 45-minute, virtual, small-group classes twice weekly for six weeks Fruit and vegetable prescription Fruit and Vegetable prescription Fruit and vegetable incentive program Fruit and vegetable prescription + Virtual Home Plate Virtual Home Plate Fruit and vegetable incentive program + 45-minute, virtual, small-group classes twice weekly for six weeks Fruit and vegetable prescription + Home Plate Lite Home Plate Lite Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks Fruit and vegetable prescription + Home Plate Lite Fruit and Vegetable prescription Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks
- Primary Outcome Measures
Name Time Method Change in Diet quality baseline and 8 weeks Diet quality of the child will be measured by use of an automated self-administered 24-hour dietary recall system (ASA24), completed by the child's caregiver. The ASA24 is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the United States Department of Agriculture (USDA) Automated Multiple-Pass Method, which has been validated. Validation and evaluation studies of ASA24 have found close agreement with standardized interview-administered 24 hour recall.
- Secondary Outcome Measures
Name Time Method Change in Food security - Hunger Coping Scale baseline and 8 weeks Food security status will be assessed using the Hunger Coping Scale. The five items from the Hunger Coping Scale question the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. "couldn't afford more food," or "there was not enough money for food") to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Change in Food security - 2-item Nutrition Security Screener (NSS) baseline and 8 weeks Food security status will be assessed using the NSS. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Program feasibility - Home Plate Class Attendance 8 weeks Program feasibility will be assessed through virtual Home Plate class attendance
Program feasibility - Participant Satisfaction 8 weeks Program feasibility will be assessed through participant feedback measured by completion of the participant satisfaction surveys and phone interviews post intervention.
Change in Food security - Food Security Survey baseline and 8 weeks Food security status will be assessed using the USDA Food Security Survey. The 18-item USDA Food Security Survey the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. "couldn't afford more food," or "there was not enough money for food") to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention.
Change in Caregiver diet quality baseline and 8 weeks Caregiver diet quality will be measured by the caregivers completion of the automated self-administered 24-hour dietary recall system (ASA24) for themselves at baseline and 8 weeks following the initiation of the nutrition education intervention. The ASA24, is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the USDA Automated Multiple-Pass Method, which has been validated.
Change in Caregiver perceived food environment baseline and 8 weeks Perceptions of food environment will be assessed using the Perceived Nutrition Environment Measures survey (NEMS-P). The survey is completed by the person who does the majority of the food shopping in a household to learn about his/her perceptions of the nutrition environments (where food is consumed or purchased, and in the home). Participants are asked to check boxes next to statements that best describe their behavior (e.g. "strongly disagree" to "strongly agree" or "never or rarely" to "almost always". Components within the survey ar examined individually. The survey can discriminate perceptions of nutrition environments between residents of higher- and lower-socioeconomic status (SES) neighborhoods. The NEMS-P will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the nutrition education intervention.
Change in Urine Metabolites Baseline and 8 weeks Urine samples will be collected from subjects at baseline and 8 weeks and measured by metabolomic analysis to quantify association with dietary biomarkers.
Change in Caregiver mental health - Depression baseline and 8 weeks The Center for Epidemiologic Studies Depressive Scale (CES-D) is a 20-item questionnaire that includes a brief self-report for which the scale is designed to measure self-reported symptoms associated with depression experienced in the past week. Participants rate each item on a scale from 0= "Rarely or none of the time (less than 1-day)", 1= "Some or a little of the time (1-2 days)," 2= "Occasionally or a moderate amount of the time (3-4 days," or 3="Most or all of the time (5-7 days)."The scale will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the interventions. High scores indicating greater depressive symptoms.
Change in Caregiver mental health - Loneliness baseline and 8 weeks Caregiver mental health will be measured using the Revised UCLA (R-UCLA) Loneliness Scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from "hardly ever" to "often". Minimum score is 3 maximum score is 9; higher scores indicate worse outcome.
Program feasibility - Voucher Redemption 8 weeks Program feasibility will be assessed through voucher redemption
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States