NCT06286514

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

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 29, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

November 29, 2023

Last Update Submit

April 3, 2026

Conditions

ObesityDiet, Healthy

Outcome Measures

Primary Outcomes (13)

  • Usability of HFI core

    Primary participant tool completion time

    1 month

  • Acceptability of HFI core

    Primary participant satisfaction ratings of tool

    1 month

  • 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

  • Concurrent criterion validity of HFI core

    Correlations of average HFI-core obesogenic scores between staff (gold standard) and primary participant

    1 month

  • 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

  • Convergent construct validity of HFI core

    Correlations of participants' average obesogenic food availability scores from HFI core with participants' BMI values

    1 month

  • Test-retest reliability of HFI core

    Correlation coefficient between participants' HFI obesogenic scores from HFI core at visit 1 and visit 2

    1 month

  • Usability of eHFI

    Primary participant tool completion time

    1 month

  • Acceptability of eHFI

    Primary participant satisfaction ratings of tool

    1 month

  • 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

  • Concurrent criterion validity of eHFI

    Correlations of average eHFI obesogenic scores between staff (gold standard) and primary participant

    1 month

  • 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

  • Convergent construct validity of eHFI

    Correlations of participants' average obesogenic food availability scores from eHFI with participants' BMI values

    1 month

Study Arms (2)

Paper Validation

validate the paper version of the Home Food Inventory

Other: No intervention

electronic validation

validate the electronic version of the Home Food Inventory

Other: No intervention

Interventions

No interventionOTHER

This is an observational study

Paper Validationelectronic validation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults over 18 who speak either English or Spanish at home and who are responsible for the majority of the cooking or grocery shopping for their family. There will be 150 participants in the paper validation phase (75 who speak English at home and 75 who speak Spanish at home) and 200 participants in the validation of the electronic Home Food Inventory (eHFI) (100 who speak Spanish at home and 100 who speak English at home)

You may qualify if:

  • Speak Spanish or English at home
  • or older
  • primary grocery shopper or meal preparer

You may not qualify if:

  • Any person younger than 18
  • lacks the capacity to consent
  • does not purchase the majority of the groceries for the home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jayne Fulkerson

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion

November 10, 2025

Study Completion

November 10, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)