- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07490652
Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KeliAnne K Hara-Hubbard, MPH
- Phone Number: 206-616-9071
- Email: harak@uw.edu
Study Contact Backup
- Name: Amy Hernandez, BS
- Email: amyh19@uw.edu
Study Locations
-
-
Washington
-
Granger, Washington, United States, 98932
- Recruiting
- Northwest Communities Education Center/Radio KDNA
-
Contact:
- Diana Diaz, MS
- Phone Number: (509) 854-2222
- Email: ddiaz@kdna.org
-
Contact:
- Leonardo Rios, RN
- Phone Number: 509-854-2222
- Email: lrios@kdna.org
-
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:
- Amy Hernandez, BS
- Email: amyh19@uw.edu
-
Principal Investigator:
- Barbara Baquero, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention condition
These stores will receive the intervention.
|
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Baquero, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00021082
- 5R01NR021642-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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