Food InsecurityNCT05941403

Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting

A study testing Enhanced Produce Prescription Implementation in people with Food Insecurity, run by Brown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Food Insecurity
What is being tested?: Enhanced Produce Prescription Implementation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesUnited States
Study dates: 1 Jun 2023to 31 Dec 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Healthcare providers/staff Inclusion Criteria:

18 years of age or older
healthcare provider/staff member who makes referrals to produce prescriptions (VeggieRx)
fluent in English and/or Spanish

Healthcare providers/staff Exclusion Criteria

under age 18
have not been involved in referral process for produce prescriptions (VeggieRx)
are not fluent in English and/or Spanish

Patient Inclusion Criteria:

18 years of age or older
enrolled in the produce prescription program (VeggieRx)
fluent in English and/or Spanish

Patient Exclusion Criteria:

under age 18
declined to enroll in the produce prescription program (VeggieRx)
are not fluent in English and/or Spanish

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Brown Research on Implementation and Dissemination to Guide Evidence use (BRIDGE) Program
Providence, Rhode Island, 02912
Department of Behavioral and Social Sciences/School of Public Health
Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting: A Pilot Study

The goal of this pilot feasibility implementation trial is to assess preliminary feasibility and acceptability of a set of produce prescription implementation strategies. Produce prescription programs are one approach to addressing food insecurity, or the lack of adequate access to safe and nutritious foods. Produce prescriptions involve healthcare providers identifying patients at risk for food insecurity and writing prescriptions for those patients to receive subsidized vegetables. In this study, the investigators will work with a community advisory board to develop a set of enhanced implementation strategies (e.g., training, technical assistance) to support healthcare providers in delivering produce prescription programs. The investigators will assess the feasibility, acceptability, and appropriateness of these strategies. Pre-post changes in implementation outcomes (i.e., adoption) and effectiveness outcomes (i.e., food security) will be examined.

Read the detailed description

Healthcare providers/staff and patients will be recruited from allied Integra health centers. Following enrollment in the already existing produce prescription program ("VeggieRx"), participants will be asked if they would be interested in participating in the research study that entails surveys regarding the program. The investigators expect to recruit participants into the study starting shortly after patients get enrolled in the program. Potential participants will be informed that their decision about whether to participate in the research study will not affect their eligibility or enrollment in the VeggieRx program. They will also be informed that this study seeks to understand strategies to improve the current VeggieRx program. A research assistant will follow-up with interested patients/providers/staff and complete enrollment, consents, and a baseline assessment, either in the waiting room to complete on their own, over the phone or Zoom, OR if they choose to complete it on their own, the study team will send them the link to the consent and survey. It should be noted that participants can either choose to complete the surveys on their own through a survey link (which will be the default) or the surveys can be administered by the study staff. The study team hopes to collect baseline measures before the delivery of their first vegetables which typically begins the second week in July. While providers/staff will not be receiving vegetables, the study team also hopes to collect their baseline data when the program begins (by second week of July). Follow-up data collection for patients will occur after their final delivery (usually end of November) and provider/staff survey will also occur around that time. The study team will communicate with the program to find out when the last deliveries are occurring (not gathering any patient information, just overall timeline).

Baseline and final measures for participating patients are each expected to take approximately 15-20 minutes. In addition, VeggieRx participants will also complete a biweekly measure of engagement which will take approximately 2-minutes each time and will be sent via text message or email depending on participants' preferences throughout the duration of the 6-month VeggieRx delivery period. These questions will ask if they received their vegetable delivery, how much they liked the vegetables, how much they used them and if they fit with their families' eating habits.

As described above, providers and staff will be contacted via email/text/phone by the research assistant asking them to participate. They can complete measures with a research assistant or on their own. Baseline and follow-up surveys for providers/staff are each expected to take 10-20 min. All previously mentioned study procedures can take place in Spanish for patients whose primary language is Spanish by the research assistant research staff that is fluent in Spanish.

Conditions: Food Insecurity
Being tested: Enhanced Produce Prescription Implementation
Keywords: food insecurity, implementation science, produce prescription program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Produce Prescription ImplementationBehavioural
Practices make modifications to their usual produce prescription program based on an implementation blueprint. While the exact implementation strategies to be added will be defined based on qualitative data (data collection in progress), possible implementation strategies may include training or technical assistance.

Study groups in NCT05941403
Study group	Role	What they receive
Enhanced Produce Prescription Implementation	Experimental	The study team will develop an enhanced implementation blueprint to support uptake of the produce prescription (VeggieRx) intervention that is informed by advisory board input and includes multiple implementation strategies to address identified barriers to implementation. Receives: Behavioral: Enhanced Produce Prescription Implementation

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores on each item indicate higher engagement. Scores range from 4-20.
Measured: Baseline
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 2
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 4
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 6
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 8
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 10
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 12
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 14
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 16
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 18
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 20
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 22
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 24
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 26
Patient Engagement with the Produce Prescription Program Questionnaire
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Measured: Week 28
Acceptability of Intervention Measure
Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.
Measured: Baseline
Acceptability of Intervention Measure
Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.
Measured: 6 month follow up
Feasibility of Intervention Measure
Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.
Measured: Baseline
Feasibility of Intervention Measure
Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.
Measured: 6 month follow up
Intervention Appropriateness Measure
Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.
Measured: Baseline
Intervention Appropriateness Measure
Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.
Measured: 6 month follow up
Evidence-Based Practice Attitudes Scale
The Evidence-Based Practice Attitudes Scale measures providers' attitudes toward evidence-based practices - specifically produce prescription programs. Scores range from 0 (not at all) to 4 (to a very great extent); higher scores indicate more positive attitudes toward evidence-based practices. Scores are calculated as an average and range from 0-4.
Measured: 6-month follow up
Feasibility of Participant Enrollment
Proportion of participants who agree to enroll in the study out of those who are enrolled in the produce prescription program
Measured: Baseline
Implementation Climate Scale
This measure of implementation climate will assess the innovation-specific organizational climate for implementing produce prescription programs. Responses will be rated on a 4-point scale ranging from 0 (not at all) to 4 (very great extent). Higher responses indicate a stronger implementation climate. Scores are calculated as an average and range from 0-4.
Measured: 6 month follow up
Implementation Readiness: Organizational Readiness for Implementing Change
This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.
Measured: Baseline
Implementation Readiness: Organizational Readiness for Implementing Change
This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.
Measured: 6-month follow up

Secondary outcomes (9)

Adoption of Produce Prescriptions
Number of patients who enroll in the produce prescription program
Measured: Baseline
Adoption of Produce Prescriptions
Number of patients who enroll in the produce prescription program
Measured: 6 month follow up
Effectiveness: Food Security
Measured by the 6-item United States Department of Agriculture measure. Total scores range from 0-6, with lower scores indicating food security.
Measured: Baseline; 6 month follow up
Effectiveness: Food Security
Measured by the 6-item United States Department of Agriculture measure. Total scores range from 0-6, with lower scores indicating more food security.
Measured: Baseline
Effectiveness: Nutrition security
measured by the 4-item Nutrition Security measure. Responses range from "never" (0) to "always" (4). Items are scored by finding a mean of included items. Lower scores indicate more nutrition security.
Measured: 6 month follow up
Effectiveness: Patient Health Questionnaire-2
The 2-item Patient Health Questionnaire will be used to screen for depression. Responses range from 0 (not at all) to 3 (nearly every day). Scores greater than 3 suggest that major depressive disorder is likely.
Measured: baseline, 6-month follow up
Effectiveness: Patient Health Questionnaire-2
The 2-item Patient Health Questionnaire will be used to screen for depression. Responses range from 0 (not at all) to 3 (nearly every day). Scores greater than 3 suggest that major depressive disorder is likely.
Measured: 6-month follow up
Effectiveness: Dietary Screener Guide
Fruit and vegetable intake will be measured by the 10-item Dietary Screener Guide, in which participants will be asked to rate the frequency with which they have eaten a variety of foods. Responses range from "never" to "6 or more times per day." The measure is scored using a scoring algorithm that converts survey responses to estimates of average daily dietary intake for fruits and/or vegetables.
Measured: baseline, 6-month follow up
Effectiveness: Dietary Screener Guide
Fruit and vegetable intake will be measured by the 10-item Dietary Screener Guide, in which participants will be asked to rate the frequency with which they have eaten a variety of foods. Responses range from "never" to "6 or more times per day." The measure is scored using a scoring algorithm that converts survey responses to estimates of average daily dietary intake for fruits and/or vegetables.
Measured: 6-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202331 Dec 2023

First posted12 Jul 2023
Study start1 Jun 2023
Primary completion30 Nov 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Food InsecurityStudies 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05941403
Sponsor's protocol ID: STUDY00000018
Other IDs: 008225
Status last verified: May 2024
First submitted: 9 Jun 2023
Last updated: 31 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Given the small dataset, data will not be made publicly available. However, de-identified quantitative data will be made available to individual investigators following a written request to the study principal investigators.

Publications

Frank HE, Guzman LE, Ayalasomayajula S, Albanese A, Dunklee B, Harvey M, Bouchard K, Vadiveloo M, Yaroch AL, Scott K, Tovar A. Developing and testing a produce prescription implementation blueprint to improve food security in a clinical setting: a pilot study protocol. Pilot Feasibility Stud. 2024 Mar 23;10(1):51. doi: 10.1186/s40814-024-01467-7.
PubMed 38521931
Fu ES, Tovar A, Tsado N, Guzman LE, Albanese AM, Dunklee B, Scott K, Frank HE. Evaluating the impact of an implementation blueprint on a produce prescription program's implementation outcomes. Transl Behav Med. 2026 Jan 7;16(1):ibag039. doi: 10.1093/tbm/ibag039.
PubMed 42358189

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting: A Pilot Study
ClinicalTrials.gov ID: NCT05941403
Acronym / sponsor ID: STUDY00000018
Conditions: Food Insecurity
Keywords: food insecurity, implementation science, produce prescription program
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: Peter G. Peterson Foundation
Study start: 1 Jun 2023 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 12 Jul 2023 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Enhanced Produce Prescription Implementation	Experimental	Behavioral: Enhanced Produce Prescription ImplementationThe study team will develop an enhanced implementation blueprint to support uptake of the produce prescription (VeggieRx) intervention that is informed by advisory board input and includes multiple implementation strategies to address identified barriers to implementation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Enhanced Produce Prescription ImplementationPractices make modifications to their usual produce prescription program based on an implementation blueprint. While the exact implementation strategies to be added will be defined based on qualitative data (data collection in progress), possible implementation strategies may include training or technical assistance.	Behavioural	Enhanced Produce Prescription Implementation

Primary outcome

Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Baseline
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores on each item indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 2
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 4
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 6
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 8
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 10
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 12
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 14
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 16
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 18
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 20
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 22
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 24
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 26
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Patient Engagement with the Produce Prescription Program Questionnaire
Time frame: Week 28
Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.
Acceptability of Intervention Measure
Time frame: Baseline
Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.
Acceptability of Intervention Measure
Time frame: 6 month follow up
Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.
Feasibility of Intervention Measure
Time frame: Baseline
Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.
Feasibility of Intervention Measure
Time frame: 6 month follow up
Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.
Intervention Appropriateness Measure
Time frame: Baseline
Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.
Intervention Appropriateness Measure
Time frame: 6 month follow up
Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.
Evidence-Based Practice Attitudes Scale
Time frame: 6-month follow up
The Evidence-Based Practice Attitudes Scale measures providers' attitudes toward evidence-based practices - specifically produce prescription programs. Scores range from 0 (not at all) to 4 (to a very great extent); higher scores indicate more positive attitudes toward evidence-based practices. Scores are calculated as an average and range from 0-4.
Feasibility of Participant Enrollment
Time frame: Baseline
Proportion of participants who agree to enroll in the study out of those who are enrolled in the produce prescription program
Implementation Climate Scale
Time frame: 6 month follow up
This measure of implementation climate will assess the innovation-specific organizational climate for implementing produce prescription programs. Responses will be rated on a 4-point scale ranging from 0 (not at all) to 4 (very great extent). Higher responses indicate a stronger implementation climate. Scores are calculated as an average and range from 0-4.
Implementation Readiness: Organizational Readiness for Implementing Change
Time frame: Baseline
This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.
Implementation Readiness: Organizational Readiness for Implementing Change
Time frame: 6-month follow up
This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.

9 secondary outcomes

Adoption of Produce Prescriptions
Time frame: Baseline
Adoption of Produce Prescriptions
Time frame: 6 month follow up
Effectiveness: Food Security
Time frame: Baseline; 6 month follow up
Effectiveness: Food Security
Time frame: Baseline
Effectiveness: Nutrition security
Time frame: 6 month follow up
Effectiveness: Patient Health Questionnaire-2
Time frame: baseline, 6-month follow up
Effectiveness: Patient Health Questionnaire-2
Time frame: 6-month follow up
Effectiveness: Dietary Screener Guide
Time frame: baseline, 6-month follow up
Effectiveness: Dietary Screener Guide
Time frame: 6-month follow up

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 31 May 2024.
Background: PubMed 38521931Frank HE, Guzman LE, Ayalasomayajula S, Albanese A, Dunklee B, Harvey M, Bouchard K, Vadiveloo M, Yaroch AL, Scott K, Tovar A. Developing and testing a produce prescription implementation blueprint to improve food security in a clinical setting: a pilot study protocol. Pilot Feasibility Stud. 2024 Mar 23;10(1):51. doi: 10.1186/s40814-024-01467-7.
Derived from this study: PubMed 42358189Fu ES, Tovar A, Tsado N, Guzman LE, Albanese AM, Dunklee B, Scott K, Frank HE. Evaluating the impact of an implementation blueprint on a produce prescription program's implementation outcomes. Transl Behav Med. 2026 Jan 7;16(1):ibag039. doi: 10.1093/tbm/ibag039.
Individual participant dataSharing planned: No. Given the small dataset, data will not be made publicly available. However, de-identified quantitative data will be made available to individual investigators following a written request to the study principal investigators.

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Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Healthy
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Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
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Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
Food Insecurity

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.

Hannah E Frank, PhD principal investigator

Brown University

Alison Tovar, PhD principal investigator

Brown University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Produce Prescription Implementation in people with Food Insecurity, run by Brown University at 2 sites 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?

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 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Patient Engagement with the Produce Prescription Program Questionnaire (time frame: Baseline). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941403, which also lists 2 linked publications.

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 31 May 2024.