NCT04995237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

July 30, 2021

Last Update Submit

April 28, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in number of vegetable servings consumed

    At each study visit, participants will self report average number of vegetable servings consumed daily.

    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.

    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

    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.

    6 weeks

  • Number of participants who feel healthier

    At each study visit, participants will be asked if they feel healthier (yes or no).

    6 weeks

Secondary Outcomes (2)

  • Change in self-reported blood pressure reading

    Baseline to 6 weeks

  • Change in self-reported blood glucose reading

    Baseline to 6 weeks

Study Arms (1)

Prescription Produce Plan (PPP)

EXPERIMENTAL

PPP provides access to fresh produce along with individual goal setting and education

Behavioral: PPP

Interventions

PPPBEHAVIORAL

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.

Prescription Produce Plan (PPP)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not interested in joining Richmond Health and Wellness Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Kimberly Battle, PhD, RN, FNP-BC

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 6, 2021

Study Start

August 5, 2021

Primary Completion

December 16, 2021

Study Completion

December 16, 2021

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations