NCT07490652

Brief 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. 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?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress10%
Apr 2026May 2029

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 18, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

Hispanic AmericansRural PopulationFruit and Vegetable ConsumptionCancer PreventionChronic Disease PreventionLatino Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6-month

Secondary Outcomes (1)

  • 12-month Fruit and Vegetable Consumption

    Baseline, 12 months

Study Arms (2)

Intervention condition

EXPERIMENTAL

These stores will receive the intervention.

Behavioral: The Value of Our Health

Control condition

NO INTERVENTION

The control condition stores will not receive the intervention during the measurement period.

Interventions

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.

Intervention condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwest Communities Education Center/Radio KDNA

Granger, Washington, 98932, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Study Officials

  • Barbara Baquero, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KeliAnne K Hara-Hubbard, MPH

CONTACT

Amy Hernandez, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director of Public Health-Global Health Major

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations