ObesityNCT06286514
Food at Home Study
An observational study of Obesity and Diet, Healthy, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diet, Healthy
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Speak Spanish or English at home
- 18 or older
- primary grocery shopper or meal preparer
Who cannot join
- Any person younger than 18
- lacks the capacity to consent
- does not purchase the majority of the groceries for the home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Obesity, Diet, Healthy
- Being tested
- No intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Paper Validation | validate the paper version of the Home Food Inventory Receives: Other: No intervention | |
| electronic validation | validate the electronic version of the Home Food Inventory Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of HFI core
Primary participant tool completion time
Measured: 1 month
Acceptability of HFI core
Primary participant satisfaction ratings of tool
Measured: 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
Measured: 1 month
Concurrent criterion validity of HFI core
Correlations of average HFI-core obesogenic scores between staff (gold standard) and primary participant
Measured: 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)
Measured: 1 month
Convergent construct validity of HFI core
Correlations of participants' average obesogenic food availability scores from HFI core with participants' BMI values
Measured: 1 month
Test-retest reliability of HFI core
Correlation coefficient between participants' HFI obesogenic scores from HFI core at visit 1 and visit 2
Measured: 1 month
Usability of eHFI
Primary participant tool completion time
Measured: 1 month
Acceptability of eHFI
Primary participant satisfaction ratings of tool
Measured: 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
Measured: 1 month
Concurrent criterion validity of eHFI
Correlations of average eHFI obesogenic scores between staff (gold standard) and primary participant
Measured: 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)
Measured: 1 month
Convergent construct validity of eHFI
Correlations of participants' average obesogenic food availability scores from eHFI with participants' BMI values
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayne Fulkerson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286514
- Sponsor's protocol ID
- STUDY00019996
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food at Home Study
- ClinicalTrials.gov ID
- NCT06286514
- Acronym / sponsor ID
- STUDY00019996
- Conditions
- Obesity, Diet, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper Validation | – | Other: No interventionvalidate the paper version of the Home Food Inventory |
| electronic validation | – | Other: No interventionvalidate the electronic version of the Home Food Inventory |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- Speak Spanish or English at home
- 18 or older
- primary grocery shopper or meal preparer
Key exclusion criteria (3 listed)
- Any person younger than 18
- lacks the capacity to consent
- does not purchase the majority of the groceries for the home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Other | Paper Validation, electronic validation |
Primary outcome
Usability of HFI core
Time frame: 1 month
Primary participant tool completion time
Acceptability of HFI core
Time frame: 1 month
Primary participant satisfaction ratings of tool
Concurrent criterion validity of HFI core
Time frame: 1 month
Correlations of average HFI-core fruit and vegetable category availability scores between staff (gold standard) and primary participant completed tools
Concurrent criterion validity of HFI core
Time frame: 1 month
Correlations of average HFI-core obesogenic scores between staff (gold standard) and primary participant
Convergent construct validity of HFI core
Time frame: 1 month
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)
Convergent construct validity of HFI core
Time frame: 1 month
Correlations of participants' average obesogenic food availability scores from HFI core with participants' BMI values
Test-retest reliability of HFI core
Time frame: 1 month
Correlation coefficient between participants' HFI obesogenic scores from HFI core at visit 1 and visit 2
Usability of eHFI
Time frame: 1 month
Primary participant tool completion time
Acceptability of eHFI
Time frame: 1 month
Primary participant satisfaction ratings of tool
Concurrent criterion validity of eHFI
Time frame: 1 month
Correlations of average eHFI fruit and vegetable category availability scores between staff (gold standard) and primary participant completed tools
Concurrent criterion validity of eHFI
Time frame: 1 month
Correlations of average eHFI obesogenic scores between staff (gold standard) and primary participant
Convergent construct validity of eHFI
Time frame: 1 month
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)
Convergent construct validity of eHFI
Time frame: 1 month
Correlations of participants' average obesogenic food availability scores from eHFI with participants' BMI values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne Fulkerson principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diet, Healthy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of HFI core (time frame: 1 month). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.