Quality of LifePPPNCT04995237
RHWP Prescription Produce Plan
A study testing PPP in people with Quality of Life, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- PPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not interested in joining Richmond Health and Wellness Program
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Richmond Health and Wellness Program (RHWP) Prescription Produce Plan (PPP) Pilot Study
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.
Read the 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:
- Complete a total of five (5) surveys and the consent process during the enrollment visit lasting approximately 30 to 60 minutes.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Quality of Life
- Being tested
- PPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPPBehavioural
Participants will be provided with a weekly bag of produce, information about how to cook the produce, assistance in setting quality of life goals, and individualized teaching to support meeting participant's set goals.
| Study group | Role | What they receive |
|---|---|---|
| Prescription Produce Plan (PPP) | Experimental | PPP provides access to fresh produce along with individual goal setting and education Receives: Behavioral: PPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of vegetable servings consumed
At each study visit, participants will self report average number of vegetable servings consumed daily.
Measured: Baseline to 6 weeks
Number of participants who met weight management goals
At each study visit, participants will self report whether or not they met their weight management goal which they set during the previous study visits.
Measured: 6 weeks
Number of participants who met blood glucose levels goals
For participants who already monitor their blood glucose, at each study visit, participants will self report whether or not they met their glucose level goals which they set during the previous study visits
Measured: 6 weeks
Number of participants who met blood pressure reduction goals
At each study visit, participants will self report whether or not they met their blood pressure reduction goal which they set during the previous study visits.
Measured: 6 weeks
Number of participants who feel healthier
At each study visit, participants will be asked if they feel healthier (yes or no).
Measured: 6 weeks
Secondary outcomes (2)
Change in self-reported blood pressure reading
Participants will be provided with an automatic blood pressure machine, shown how to use it with, and given a handout with instructions on how to record and monitor their blood pressure at home. Participant will self-report the results of their blood pressure reading during the study visits.
Measured: Baseline to 6 weeks
Change in self-reported blood glucose reading
For participants who already monitor their blood glucose, participants will self-report the results of their blood glucose reading during the study visits.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start5 Aug 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Battle, PhD, RN, FNP-BC, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995237
- Sponsor's protocol ID
- HM20022162
- Acronym
- PPP
- Status last verified
- Apr 2023
- First submitted
- 30 Jul 2021
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Richmond Health and Wellness Program (RHWP) Prescription Produce Plan (PPP) Pilot Study
- ClinicalTrials.gov ID
- NCT04995237
- Acronym / sponsor ID
- PPP / HM20022162
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Complete a total of five (5) surveys and the consent process during the enrollment visit lasting approximately 30 to 60 minutes.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescription Produce Plan (PPP) | Experimental | Behavioral: PPPPPP provides access to fresh produce along with individual goal setting and education |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- not interested in joining Richmond Health and Wellness Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPPParticipants will be provided with a weekly bag of produce, information about how to cook the produce, assistance in setting quality of life goals, and individualized teaching to support meeting participant's set goals. | Behavioural | Prescription Produce Plan (PPP) |
Primary outcome
Change in number of vegetable servings consumed
Time frame: Baseline to 6 weeks
At each study visit, participants will self report average number of vegetable servings consumed daily.
Number of participants who met weight management goals
Time frame: 6 weeks
At each study visit, participants will self report whether or not they met their weight management goal which they set during the previous study visits.
Number of participants who met blood glucose levels goals
Time frame: 6 weeks
For participants who already monitor their blood glucose, at each study visit, participants will self report whether or not they met their glucose level goals which they set during the previous study visits
Number of participants who met blood pressure reduction goals
Time frame: 6 weeks
At each study visit, participants will self report whether or not they met their blood pressure reduction goal which they set during the previous study visits.
Number of participants who feel healthier
Time frame: 6 weeks
At each study visit, participants will be asked if they feel healthier (yes or no).
2 secondary outcomes
Change in self-reported blood pressure reading
Time frame: Baseline to 6 weeks
Change in self-reported blood glucose reading
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Battle, PhD, RN, FNP-BC principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPP in people with Quality of Life, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of vegetable servings consumed (time frame: Baseline to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.