Obesity Clinical Trial
Official title:
Food at Home Study
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 |
Verified date | April 2024 |
Source | University of Minnesota |
Contact | Fanny Jimbo Llapa |
food-at-home[@]umn.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
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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