- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475526
The Value of Our Health
November 16, 2015 updated by: Guadalupe X. Ayala, San Diego State University
El Valor de Nuestra Salud (The Value of Our Health)
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.
Sixteen 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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Sixteen stores in San Diego County participated in El Valor de Nuestra Salud.
The stores that participated in this study were randomly assigned to either the intervention (program and evaluation) or control (evaluation only) group.
We tested various strategies to promote healthy food shopping among customers of small-to-medium size Latino/Hispanic grocery stores.
These strategies included changes to the store environment, food marketing efforts, and training of sales associates.
Our evaluation protocol is designed to determine whether the project was successful at improving aspects of the store and the employees, as well as whether customers shop for and eat healthier food products.
Customers were recruited as they enter the store to participate in project interviews and objective weight measures at baseline, 6-months post-baseline, and 12-months post-baseline.
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.
Study Type
Interventional
Enrollment (Actual)
370
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- San Diego State University Research Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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
No intervention.
Business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Guadalupe X Ayala, PhD, San Diego State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 14, 2011
First Submitted That Met QC Criteria
November 18, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Estimate)
November 17, 2015
Last Update Submitted That Met QC Criteria
November 16, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA140326 (U.S. NIH Grant/Contract)
- 5R01CA140326-02 (U.S. NIH Grant/Contract)
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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