Clinical trial NCT04995237: RHWP Prescription Produce Plan
Official title: Richmond Health and Wellness Program (RHWP) Prescription Produce Plan (PPP) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to find out if access to fresh produce along with individual goal setting and education influences vegetable consumption, self-management \[self-efficacy\], resilience, or quality of life. Researcher think access to fresh produce along with individual goal setting and education, may improve all of the above. This study will allow them to learn more about it.

Detailed description: This research study focused on examining how a Prescription Produce Plan (PPP) may influence vegetable consumption, self-management \[self-efficacy\], resilience, and quality of life in older adults. This research study involves meeting with a team of VCU students and faculty to learn information about nutrition.

In this study, participants will be asked to do the following things:

1. Complete a total of five (5) surveys and the consent process during the enrollment visit lasting approximately 30 to 60 minutes.
2. Record their blood pressure readings and blood glucose readings \[if they already do this\] once a week in a notebook provided by the research team and then self-report the blood pressure and blood glucose readings at the next two (2) study visits.
3. Receive individualized teaching supporting obtaining the goals at this visit and future study visits. The study team will discuss with participants the contents of the produce bags and how to cook the contents of the bag. They will also work with participants to set goals for themselves. Goals for this study will focus on vegetable consumption, weight management, and either blood pressure and/or blood glucose measurements. The initial study visit may last approximately 30 minutes.
4. At the end of the initial study visit, you will receive a voucher from the Shalom Farms Mobile Market for once a week redemption over the course of 6 weeks while participating in the program. VCU Health Hub 25th Street participants will receive a produce bag at the end of this visit and will need to come to the Health Hub weekly to pick up the produce bag.
5. Subsequent study visits will focus on participant goals. Participants will meet with the study team to discuss if goals were met or not met and the study team will provide individualized teaching to support meeting participant's set goals. The study team will ask participants to meet with them twice after the initial study visit for approximately 20 to 30 minutes at each visit. These meetings will be at Week #3 and at Week #6.
6. Participants will record in provided notebooks their blood pressure, weight, and blood glucose \[if they are already checking their blood glucose prior to participating in this study\]. These measurements will also be reported during study visits.
7. Participants are asked to meet with a member of the research team after six (6) weeks of participating in the study to complete a total of three (3) post-study surveys. This visit will last approximately 30 minutes.

Participation in this study will last up to 8 weeks for a total of approximately 3 hours of in person visits. Approximately 30 individuals will participate in this study.

Eligibility criteria: Inclusion Criteria:

* Richmond Health Wellness Program \[RHWP\]Participant or interested in joining RHWP
* age 40 and older
* live in Richmond
* have a desire to set goals having access to fresh produce

Exclusion Criteria:

• not interested in joining Richmond Health and Wellness Program

Primary outcomes:
measure: Change in number of vegetable servings consumed
timeFrame: Baseline to 6 weeks
measure: Number of participants who met weight management goals
timeFrame: 6 weeks
measure: Number of participants who met blood glucose levels goals
timeFrame: 6 weeks
measure: Number of participants who met blood pressure reduction goals
timeFrame: 6 weeks
measure: Number of participants who feel healthier
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in self-reported blood pressure reading
timeFrame: Baseline to 6 weeks
measure: Change in self-reported blood glucose reading
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kimberly Battle, PhD, RN, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References: