- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623202
Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos
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
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amanda C McClain, PhD, MS
- Phone Number: 6195947272
- Email: amcclain@sdsu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capacity-oriented behavior-change intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet quality
Time Frame: 3 months
|
Food Behavior Checklist for Spanish-speaking participants
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Household food security status
Time Frame: 6 weeks, 3 months
|
U.S. Department of Agriculture 18-item Household Food Security Survey Module
|
6 weeks, 3 months
|
Self-efficacy for food security
Time Frame: 6 weeks, 3 months
|
Self-efficacy for food security scale (Martin et al, 2016)
|
6 weeks, 3 months
|
Food resource management knowledge
Time Frame: 6 weeks, 3 months
|
Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire
|
6 weeks, 3 months
|
Food resource management knowledge
Time Frame: 6 weeks, 3 months
|
Knowledge of available local food resources (checklist)
|
6 weeks, 3 months
|
Food resource management skills
Time Frame: 6 weeks, 3 months
|
Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire
|
6 weeks, 3 months
|
Food resource management skills
Time Frame: 6 weeks, 3 months
|
Use/access of available local food resources (checklist)
|
6 weeks, 3 months
|
Material capital
Time Frame: 6 weeks, 3 months
|
Perceived neighborhood food availability and affordability scale
|
6 weeks, 3 months
|
Human capital
Time Frame: 6 weeks, 3 months
|
Life Orientation Test (optimism subscale)
|
6 weeks, 3 months
|
Social capital
Time Frame: 6 weeks, 3 months
|
Neighborhood cohesion scale
|
6 weeks, 3 months
|
Social capital
Time Frame: 6 weeks, 3 months
|
Family cohesion scale
|
6 weeks, 3 months
|
Cultural capital
Time Frame: 6 weeks, 3 months
|
Familism scale
|
6 weeks, 3 months
|
Cultural capital
Time Frame: 6 weeks, 3 months
|
Simpatia scale
|
6 weeks, 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HL150406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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