The Value of Our Health

Diet Clinical Trial

Official title:

El Valor de Nuestra Salud (The Value of Our Health)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475526
• Other study ID #: R01CA140326
• Secondary ID: 5R01CA140326-02
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: November 16, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Diet
• Prevention and Control
• Prevention of Chronic Disease

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.

Locations

Country	Name	City	State
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fruit and vegetable consumption of store customers from baseline to 6-months as assessed by the NCI fruit and vegetable screener		Baseline, 6 months	No

External Links

•   El Valor de Nuestra Salud is housed within the Institute for Behavioral and Community Health at SDSU