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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06286514
Other study ID # STUDY00019996
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date March 30, 2026

Study information

Verified date April 2024
Source University of Minnesota
Contact Fanny Jimbo Llapa
Email food-at-home@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date March 30, 2026
Est. primary completion date March 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Speak Spanish or English at home - 18 or older - primary grocery shopper or meal preparer Exclusion Criteria: - Any person younger than 18 - lacks the capacity to consent - does not purchase the majority of the groceries for the home

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This is an observational study

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usability of HFI core Primary participant tool completion time 1 month
Primary Acceptability of HFI core Primary participant satisfaction ratings of tool 1 month
Primary Concurrent criterion validity of HFI core Correlations of average HFI-core fruit and vegetable category availability scores between staff (gold standard) and primary participant completed tools 1 month
Primary Concurrent criterion validity of HFI core Correlations of average HFI-core obesogenic scores between staff (gold standard) and primary participant 1 month
Primary Convergent construct validity of HFI core Correlations of participants' average fruit and vegetable category availability scores from HFI core with participants' average corresponding servings of fruit and vegetables reported from average of two days of dietary recall (in native language) 1 month
Primary Convergent construct validity of HFI core Correlations of participants' average obesogenic food availability scores from HFI core with participants' BMI values 1 month
Primary Test-retest reliability of HFI core Correlation coefficient between participants' HFI obesogenic scores from HFI core at visit 1 and visit 2 1 month
Primary Usability of eHFI Primary participant tool completion time 1 month
Primary Acceptability of eHFI Primary participant satisfaction ratings of tool 1 month
Primary Concurrent criterion validity of eHFI Correlations of average eHFI fruit and vegetable category availability scores between staff (gold standard) and primary participant completed tools 1 month
Primary Concurrent criterion validity of eHFI Correlations of average eHFI obesogenic scores between staff (gold standard) and primary participant 1 month
Primary Convergent construct validity of eHFI Correlations of participants' average fruit and vegetable category availability scores from eHFI with participants' average corresponding servings of fruit and vegetables reported from average of two days of dietary recall (in native language) 1 month
Primary Convergent construct validity of eHFI Correlations of participants' average obesogenic food availability scores from eHFI with participants' BMI values 1 month
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