Prevention of Chronic DiseaseNCT01475526
The Value of Our Health
A study testing El Valor de Nuestra Salud Store Intervention in people with Prevention of Chronic Disease and Prevention and Control, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Chronic Disease, Prevention and Control, Diet
- What is being tested?
- El Valor de Nuestra Salud Store Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University Research Foundation
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Prevention of Chronic Disease, Prevention and Control, Diet
- Being tested
- El Valor de Nuestra Salud Store Intervention
- Keywords
- grocery store, nutrition, Latino, Hispanic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
El Valor de Nuestra Salud Store InterventionOther
Changes to physical and social environment of grocery stores through implementation of the El Valor de Nuestra Salud intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | El Valor de Nuestra Salud Store Intervention Receives: Other: El Valor de Nuestra Salud Store Intervention |
| Control | No intervention | No intervention. Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fruit and vegetable consumption of store customers from baseline to 6-months as assessed by the NCI fruit and vegetable screener
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prevention of Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Guadalupe X. Ayala, San Diego State University
- Investigators
- Guadalupe X Ayala, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475526
- Sponsor's protocol ID
- R01CA140326
- Other IDs
- 5R01CA140326-02
- Status last verified
- Nov 2015
- First submitted
- 14 Nov 2011
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stuber JM, Beulens JW, Ayala GX, Crozier SR, Dijkstra SC, Lin SF, Vogel C, Mackenbach JD. Can nudge interventions targeting healthy food purchases in real-world grocery stores reduce diet-related health disparities? A pooled analysis of four controlled trials. Int J Behav Nutr Phys Act. 2024 Dec 3;21(1):137. doi: 10.1186/s12966-024-01687-3.
PubMed 39627771Ayala GX, Pickrel JL, Baquero B, Sanchez-Flack J, Lin SF, Belch G, Rock CL, Linnan L, Gittelsohn J, Ji M, Elder JP, Mayer J. The El Valor de Nuestra Salud clustered randomized controlled trial store-based intervention to promote fruit and vegetable purchasing and consumption. Int J Behav Nutr Phys Act. 2022 Feb 17;19(1):19. doi: 10.1186/s12966-021-01220-w.
PubMed 35177070
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- El Valor de Nuestra Salud (The Value of Our Health)
- ClinicalTrials.gov ID
- NCT01475526
- Acronym / sponsor ID
- R01CA140326
- Conditions
- Prevention of Chronic Disease, Prevention and Control, Diet
- Keywords
- grocery store, nutrition, Latino, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: El Valor de Nuestra Salud Store InterventionEl Valor de Nuestra Salud Store Intervention |
| Control | No intervention | –No intervention. Business as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| El Valor de Nuestra Salud Store InterventionChanges to physical and social environment of grocery stores through implementation of the El Valor de Nuestra Salud intervention. | Other | Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Derived from this study: PubMed 39627771Stuber JM, Beulens JW, Ayala GX, Crozier SR, Dijkstra SC, Lin SF, Vogel C, Mackenbach JD. Can nudge interventions targeting healthy food purchases in real-world grocery stores reduce diet-related health disparities? A pooled analysis of four controlled trials. Int J Behav Nutr Phys Act. 2024 Dec 3;21(1):137. doi: 10.1186/s12966-024-01687-3.
- Derived from this study: PubMed 35177070Ayala GX, Pickrel JL, Baquero B, Sanchez-Flack J, Lin SF, Belch G, Rock CL, Linnan L, Gittelsohn J, Ji M, Elder JP, Mayer J. The El Valor de Nuestra Salud clustered randomized controlled trial store-based intervention to promote fruit and vegetable purchasing and consumption. Int J Behav Nutr Phys Act. 2022 Feb 17;19(1):19. doi: 10.1186/s12966-021-01220-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guadalupe X Ayala, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing El Valor de Nuestra Salud Store Intervention in people with Prevention of Chronic Disease and Prevention and Control, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01475526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.