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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR021642-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention condition | Experimental | These stores will receive the intervention. |
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| Control condition | No Intervention | The control condition stores will not receive the intervention during the measurement period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Value of Our Health | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
In order for an individual to participate in this study, the individual must meet all of the following criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KeliAnne K Hara-Hubbard, MPH | Contact | 206-616-9071 | harak@uw.edu | |
| Amy Hernandez, BS | Contact | amyh19@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Baquero, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Communities Education Center/Radio KDNA | Recruiting | Granger | Washington | 98932 | United States |
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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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.
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| Baseline, 12 months |
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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