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Recruiting NCT07490652

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

No phase Interventional Hispanic Americans Chronic Disease Prevention Cancer Prevention Fruit and Vegetable Consumption

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Value of Our Health.
Who it may be relevant to
Registry conditions: Hispanic Americans, Chronic Disease Prevention, Cancer Prevention, Fruit and Vegetable Consumption. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 w

Primary outcome measures

  • 6-month Fruit and Vegetable Consumption [Time frame: Baseline, 6-month]
Secondary outcome measures (1)
  • 12-month Fruit and Vegetable Consumption [Time frame: Baseline, 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Northwest Communities Education Center/Radio KDNA — Granger
  • University of Washington — Seattle

Identifiers

NCT: NCT07490652 · STUDY00021082 · 5R01NR021642-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗