The Value of Our Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Guadalupe X. Ayala, San Diego State University
ClinicalTrials.gov Identifier:
NCT01475526
First received: November 14, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

El Valor de Nuestra Salud [The Value of Our Health] is a 5-year study (2010-2014) involving grocery stores in San Diego County funded by the National Cancer Institute. The purpose of the study is to determine whether an in-store program can promote healthy foods through grocery stores. Eighteen stores in San Diego County will participate in El Valor de Nuestra Salud. The stores that participate in this study will be randomly assigned to either the intervention (program and evaluation) or control (evaluation only) group. We will test various strategies to promote healthy food shopping among customers of small-to-medium size Latino/Hispanic grocery stores. These strategies include changes to the store environment, food marketing efforts, and training of sales associates. Our evaluation protocol will determine whether the project is successful at improving aspects of the store and the employees, as well as whether customers shop for and eat healthier food products. The primary aim of the study is to evaluate the impact of the El Valor de Nuestra Salud intervention on consumption of fruits and vegetables among store customers.


Condition Intervention
Prevention of Chronic Disease
Other: El Valor de Nuestra Salud Store Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: El Valor de Nuestra Salud (The Value of Our Health)

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Changes in fruit and vegetable consumption of store customers from baseline to 6-months as assessed by the NCI fruit and vegetable screener [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: October 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
El Valor de Nuestra Salud Store Intervention
Other: El Valor de Nuestra Salud Store Intervention
Changes to physical and social environment of grocery stores through implementation of the El Valor de Nuestra Salud intervention.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must be one of the main food shoppers of the household
  • Must shop at study store at least once per week
  • Must already be a purchaser of food products from this store
  • Must be Latino
  • Must speak Spanish and/or English
  • Must be able to read in Spanish
  • Must eat 4 or less cups of fruits and vegetables per day
  • Must plan on living in San Diego County for at least the next 12 months

Exclusion Criteria:

  • Must not have any dietary restrictions limiting consumption of fruits and vegetables
  • Participating customers cannot shop at other study stores in that wave more than once a month
  • Participating customers cannot shop at intervention stores from previous waves more than once a month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475526

Locations
United States, California
San Diego State University Research Foundation
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Guadalupe X Ayala, PhD San Diego State University
  More Information

Additional Information:
No publications provided

Responsible Party: Guadalupe X. Ayala, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT01475526     History of Changes
Other Study ID Numbers: R01 CA140326, 5R01CA140326-02
Study First Received: November 14, 2011
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
grocery store
nutrition
Latino
Hispanic

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014