Nutrition, HealthyNCT05623202
Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos
A study testing Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults in people with Nutrition, Healthy and Knowledge, Attitudes, Practice, run by San Diego State University.
Trial summary
Despite a large proportion exhibiting cardiovascular disease risk factors and experiencing food insecurity, U.S. Hispanics/Latinos demonstrate low cardiovascular mortality, which may indicate existing capital (e.g., assets) protecting health and diet. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Knowledge, Attitudes, Practice, Self Efficacy
- What is being tested?
- Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Hispanic/Latino
- Living full-time in San Diego County with no plan to move in next 3 months
- At or below 200% of Federal Poverty Line
Who cannot join
- Not Hispanic/Latino
- Living outside San Diego County
- Living only part-time in San Diego County
- Planning to move out of San Diego County in next 3 months
- >200% of Federal Poverty Line
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Intervention Study for Capacity-oriented Approaches to Food Security, Diet Quality, and Cardiovascular Disease Risk Among Hispanics/Latinos
Despite a large proportion exhibiting cardiovascular disease risk factors and experiencing food insecurity, U.S. Hispanics/Latinos demonstrate low cardiovascular mortality, which may indicate existing capital (e.g., assets) protecting health and diet. The goal of this study is to evaluate the feasibility and short-term efficacy of a pilot intervention aimed at improving diet quality through strengthening food- and diet-related capital and food security among low-income, Hispanic/Latino adults in San Diego, California. The pilot intervention will be integrated into an existing local health or nutrition program serving low-income Hispanic/Latino adults. Participants will be asked to:
- Complete questionnaires before and after the intervention
- Engage in nutrition education activities
- Engage in food access-related activities
- Being tested
- Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adultsBehavioural
The behavior-change intervention with low-income Hispanic/Latino adults will mobilize existing sources of human, material, social, and cultural capital at the individual, household, social, and community level, and will include a nutrition education component and a food access component.
| Study group | Role | What they receive |
|---|---|---|
| Capacity-oriented behavior-change intervention | Experimental | Not described Receives: Behavioral: Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
Food Behavior Checklist for Spanish-speaking participants
Measured: 3 months
Secondary outcomes (12)
Household food security status
U.S. Department of Agriculture 18-item Household Food Security Survey Module
Measured: 6 weeks, 3 months
Self-efficacy for food security
Self-efficacy for food security scale (Martin et al, 2016)
Measured: 6 weeks, 3 months
Food resource management knowledge
Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire
Measured: 6 weeks, 3 months
Food resource management knowledge
Knowledge of available local food resources (checklist)
Measured: 6 weeks, 3 months
Food resource management skills
Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire
Measured: 6 weeks, 3 months
Food resource management skills
Use/access of available local food resources (checklist)
Measured: 6 weeks, 3 months
Material capital
Perceived neighborhood food availability and affordability scale
Measured: 6 weeks, 3 months
Human capital
Life Orientation Test (optimism subscale)
Measured: 6 weeks, 3 months
Social capital
Neighborhood cohesion scale
Measured: 6 weeks, 3 months
Social capital
Family cohesion scale
Measured: 6 weeks, 3 months
Cultural capital
Familism scale
Measured: 6 weeks, 3 months
Cultural capital
Simpatia scale
Measured: 6 weeks, 3 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 2022
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623202
- Sponsor's protocol ID
- HL150406
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention Study for Capacity-oriented Approaches to Food Security, Diet Quality, and Cardiovascular Disease Risk Among Hispanics/Latinos
- ClinicalTrials.gov ID
- NCT05623202
- Acronym / sponsor ID
- HL150406
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2022 (actual)
- 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.
Despite a large proportion exhibiting cardiovascular disease risk factors and experiencing food insecurity, U.S. Hispanics/Latinos demonstrate low cardiovascular mortality, which may indicate existing capital (e.g., assets) protecting health and diet. The goal of this study is to evaluate the feasibility and short-term efficacy of a pilot intervention aimed at improving diet quality through strengthening food- and diet-related capital and food security among low-income, Hispanic/Latino adults in San Diego, California. The pilot intervention will be integrated into an existing local health or nutrition program serving low-income Hispanic/Latino adults. Participants will be asked to:
- Complete questionnaires before and after the intervention
- Engage in nutrition education activities
- Engage in food access-related activities
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capacity-oriented behavior-change intervention | Experimental | Behavioral: Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Hispanic/Latino
- Living full-time in San Diego County with no plan to move in next 3 months
- At or below 200% of Federal Poverty Line
Key exclusion criteria (5 listed)
- Not Hispanic/Latino
- Living outside San Diego County
- Living only part-time in San Diego County
- Planning to move out of San Diego County in next 3 months
- >200% of Federal Poverty Line
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 |
|---|---|---|
| Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adultsThe behavior-change intervention with low-income Hispanic/Latino adults will mobilize existing sources of human, material, social, and cultural capital at the individual, household, social, and community level, and will include a nutrition education component and a food access component. | Behavioural | Capacity-oriented behavior-change intervention |
Primary outcome
Diet quality
Time frame: 3 months
Food Behavior Checklist for Spanish-speaking participants
12 secondary outcomes
Household food security status
Time frame: 6 weeks, 3 months
Self-efficacy for food security
Time frame: 6 weeks, 3 months
Food resource management knowledge
Time frame: 6 weeks, 3 months
Food resource management knowledge
Time frame: 6 weeks, 3 months
Food resource management skills
Time frame: 6 weeks, 3 months
Food resource management skills
Time frame: 6 weeks, 3 months
Material capital
Time frame: 6 weeks, 3 months
Human capital
Time frame: 6 weeks, 3 months
Social capital
Time frame: 6 weeks, 3 months
Social capital
Time frame: 6 weeks, 3 months
Cultural capital
Time frame: 6 weeks, 3 months
Cultural capital
Time frame: 6 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Nutrition, Healthy
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults in people with Nutrition, Healthy and Knowledge, Attitudes, Practice, run by San Diego State University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda C McClain, PhD, MS (6195947272, amcclain@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.