NCT05623202

Brief 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. 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
3.7 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

November 1, 2022

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diet quality

    Food Behavior Checklist for Spanish-speaking participants

    3 months

Secondary Outcomes (12)

  • Household food security status

    6 weeks, 3 months

  • Self-efficacy for food security

    6 weeks, 3 months

  • Food resource management knowledge

    6 weeks, 3 months

  • Food resource management knowledge

    6 weeks, 3 months

  • Food resource management skills

    6 weeks, 3 months

  • +7 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Capacity-oriented behavior-change intervention

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Central Study Contacts

Amanda C McClain, PhD, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 21, 2022

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share