Purpose

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?

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention condition
These stores will receive the intervention.
  • 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 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.

Recruiting Locations

Northwest Communities Education Center/Radio KDNA
Granger, Washington 98932
Contact:
Diana Diaz, MS
(509) 854-2222
ddiaz@kdna.org

University of Washington
Seattle, Washington 98195
Contact:
KeliAnne K Hara-Hubbard, MPH
206-616-9071
harak@uw.edu

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

KeliAnne K Hara-Hubbard, MPH
206-616-9071
harak@uw.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.