Hispanic AmericansNCT07490652
Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention
A study testing The Value of Our Health in people with Hispanic Americans and Chronic Disease Prevention, run by University of Washington at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hispanic Americans, Chronic Disease Prevention, Cancer Prevention
- What is being tested?
- The Value of Our Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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/50signsvisibleintoxication.pdf
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Hernandez, BS contact
United States2 sites, 2 recruiting
- Recruiting
Northwest Communities Education Center/Radio KDNA
Granger, Washington, 98932
Diana Diaz, MS, (509) 854-2222, ddiaz@kdna.org
Leonardo Rios, RN, 509-854-2222, lrios@kdna.org
- Recruiting
University of Washington
Seattle, Washington, 98195
KeliAnne K Hara-Hubbard, MPH, 206-616-9071, harak@uw.edu
Amy Hernandez, BS, amyh19@uw.edu
About this study
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?
Read the 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.
- Conditions
- Hispanic Americans, Chronic Disease Prevention, Cancer Prevention, Fruit and Vegetable Consumption
- Being tested
- The Value of Our Health
- Keywords
- Hispanic Americans, Rural Population, Fruit and Vegetable Consumption, Cancer Prevention, Chronic Disease Prevention, Latino Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Value of Our HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | These stores will receive the intervention. Receives: Behavioral: The Value of Our Health |
| Control condition | No intervention | The control condition stores will not receive the intervention during the measurement period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Fruit and Vegetable Consumption
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.
Measured: Baseline, 6-month
Secondary outcomes (1)
12-month Fruit and Vegetable Consumption
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.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start17 Apr 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hispanic AmericansStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a hybrid type I cluster randomized-controlled-trial design. Clustering is on the store level. Stores will be pair-matched and randomized to the intervention or control condition. Stores randomized to the intervention will receive it first. Participants in this study are assigned to either the intervention or delayed control group based on the random assignment of their affiliated store.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Barbara Baquero, University of Washington
- Investigators
- Barbara Baquero, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490652
- Sponsor's protocol ID
- STUDY00021082
- Other IDs
- 5R01NR021642-02
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention
- ClinicalTrials.gov ID
- NCT07490652
- Acronym / sponsor ID
- STUDY00021082
- Conditions
- Hispanic Americans, Chronic Disease Prevention, Cancer Prevention, Fruit and Vegetable Consumption
- Keywords
- Hispanic Americans, Rural Population, Fruit and Vegetable Consumption, Cancer Prevention, Chronic Disease Prevention, Latino Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Mar 2026 (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 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?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a hybrid type I cluster randomized-controlled-trial design. Clustering is on the store level. Stores will be pair-matched and randomized to the intervention or control condition. Stores randomized to the intervention will receive it first. Participants in this study are assigned to either the intervention or delayed control group based on the random assignment of their affiliated store.
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: The Value of Our HealthThese stores will receive the intervention. |
| Control condition | No intervention | –The control condition stores will not receive the intervention during the measurement period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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/50signsvisibleintoxication.pdf
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 |
|---|---|---|
| The Value of Our HealthThe 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. | Behavioural | Intervention condition |
Primary outcome
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.
1 secondary outcome
12-month Fruit and Vegetable Consumption
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Amy Hernandez, BS contact
Barbara Baquero, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Value of Our Health in people with Hispanic Americans and Chronic Disease Prevention, run by University of Washington 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?
The sponsor lists 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KeliAnne K Hara-Hubbard, MPH (206-616-9071, harak@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Fruit and Vegetable Consumption (time frame: Baseline, 6-month). 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 12 Aug 2026.