Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention

April 15, 2026 updated by: Barbara Baquero, University of Washington
The goal of this clinical trial is to adapt and implement The Value of Our Health (Our Value), a program to promote eating fruit and vegetables, for people living in rural areas. The program will be offered in small, independent grocery stores and delivered by community health workers. The main question this study will answer is: Do customers who shop at stores receiving Our Value eat more fruits and vegetables than customers of other stores?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this trial, researchers seek to augment the benefits of Our Value by adding community health workers (CHWs) to deliver the intervention and adapting and testing its effectiveness in rural communities in central Washington State. People in these rural areas experience social and structural barriers to the consumption of fruits and vegetables (FV), such as limited access to fresh, varied, affordable FV and long commutes to food retailers. Yet, these communities also have a strong identity and supportive community networks; thus, our partners endorsed training CHWs to deliver the intervention. CHWs are known for effective delivery of health promotion interventions to reduce health disparities; they are recognized as trusted and respected leaders in rural communities.

To test the implementation and effectiveness of the adapted intervention, researchers use a hybrid type I cluster-randomized controlled trial (RCT) study design and apply the Retail Food Environment and Customer Interactions Model and RE-AIM framework. The study will occur in three rural counties in Washington State.

To evaluate the effects of the intervention on customers, the research team will conduct customer surveys to measure fruit and vegetable purchasing and eating.

The proposed study will contribute to reducing access to FV-related chronic disease health disparities in rural areas through behavioral-, store-, and community-level intervention. The study will shed light on the nuances, resources, and challenges of conducting health promotion and disease prevention research in rural areas. The results will provide new tools and evidence for researchers and practitioners to translate and implement evidence-based interventions in rural communities, and community-level health promotion interventions to reduce health disparities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: KeliAnne K Hara-Hubbard, MPH
  • Phone Number: 206-616-9071
  • Email: harak@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Granger, Washington, United States, 98932
        • Recruiting
        • Northwest Communities Education Center/Radio KDNA
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Elizabeth Torres, BA
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • KeliAnne K Hara-Hubbard, MPH
          • Phone Number: 206-616-9071
          • Email: harak@uw.edu
        • Contact:
        • Principal Investigator:
          • Barbara Baquero, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

In order for an individual to participate in this study, the individual must meet all of the following criteria:

  • Identify as Latino or Hispanic
  • Be at least 18 years or older
  • Live in Benton, Franklin, or Yakima county for at least 6 months and plan to remain there for the next 12 months
  • Visit this store at least once per week
  • Be primary household shopper (conducting 50% of shopping duties)
  • Eat 4 or less servings of fruits and vegetables per week Only one participant per household will be recruited to ensure the independence of observations.

Exclusion criteria:

Subjects who do not meet the inclusion criteria above will be excluded from the study. If any subject shows 3 or more visual signs of intoxication or impairment, they will be excluded from the study. The study team member will assess visual signs of intoxication during recruitment using the Oregon Liquor & Cannabis Commission 50 Signs of Visual Intoxication assessment. A link to these signs can be found here: https://www.oregon.gov/olcc/docs/publications/50_signs_visible_intoxication.pdf

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention condition
These stores will receive the intervention.
Behavioral: The Value of Our Health
The Value of Our Health is a 12-month program. Community health workers (CHWs) lead the first six months of structural and social change activities, followed by six months of store manager and employee-led activities, and technical assistance from CHWs. During the first 6 months, CHWs will work directly with the store staff to plan for structural changes at the store to promote fruit and vegetable (FV) purchasing and consumption. CHWs will deliver store staff training to promote FVs. CHWs will welcome customers into the program at the store by offering social and structural change strategies directed to customers and reinforced by store managers and employees. CHWs will work with employees to deliver a Point of Purchase campaign highlighting recipes and fresh FV sold in the stores. Employees will receive newsletters that reinforce their training. During months 7-12, CHWs will visit the store to support the maintenance of social and structural changes made in the first 6 months.
No Intervention: Control condition
The control condition stores will not receive the intervention during the measurement period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-month Fruit and Vegetable Consumption
Time Frame: Baseline, 6-month
The validated NCI Fruit and Vegetable (FV) All-Day Screener will be used to measure daily servings of FV consumed in the past month at baseline and at 6-months. The 19-item screener has been used in several large epidemiological and intervention studies is correlated with four 24-hr dietary recalls for both men (r=.59) and women (r=.56). The instrument provides ten response options for each food item ranging from "never" to "5 or more times a day." The screener also includes portion-size estimates, which have been shown to increase the accuracy of the estimates in predicting actual FV intake. The screener produces a final continuous score that reflects daily FV servings. Researchers will use food models to assist with portion estimations consistent with previous research.
Baseline, 6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
12-month Fruit and Vegetable Consumption
Time Frame: Baseline, 12 months
The validated NCI Fruit and Vegetable (FV) All-Day Screener will be used to measure daily servings of FV consumed in the past month at baseline and at 12-months. The 19-item screener has been used in several large epidemiological and intervention studies is correlated with four 24-hr dietary recalls for both men (r=.59) and women (r=.56). The instrument provides ten response options for each food item ranging from "never" to "5 or more times a day." The screener also includes portion-size estimates, which have been shown to increase the accuracy of the estimates in predicting actual FV intake. The screener produces a final continuous score that reflects daily FV servings. Researchers will use food models to assist with portion estimations consistent with previous research.
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara Baquero, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021082
  • 5R01NR021642-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified quantitative data, which will include participant characteristics, CHW characteristics, and organizational demographics will be preserved and accessible. Interview recordings, organizational observations, and individual-level participant data will not be shared directly to protect privacy. However, findings from all scientific data will be shared first with the research team and participating community organizations, then will be made available to community members including tienda owners, employees, and customers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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