Dietary HabitsNCT06455111
Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study
A study testing Keenoa and ASA24 in people with Dietary Habits, run by Boston University at 1 site in United States.
Trial summary
Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Keenoa and ASA24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FHS participants from the Gen 3 cohort who will attend the Exam 4 cycle
Who cannot join
- Participants with cognitive impairment which may prevent them from being able to complete diet records and follow instructions for continuous glucose monitor device wear.
Trial locations and contacts
1 site in 1 country.
United States1 site
BU Chobanian & Avedisian School of Medicine, Framingham Heart Study
Boston, Massachusetts, 02118
About this study
Official title: Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study: A Block Randomized Controlled Trial
Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Further utilizing food recognition technologies to capture real-time food intake may aid in overcoming limitations of existing methods. Keenoa, an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data.
Primarily, the investigators will assess acceptability and usability of Keenoa compared with the traditional, web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in the Framingham Heart Study Third Generation-based cohorts at examination 4. The investigators will also determine the proportion of participants who complete all three days of dietary assessment, either through Keenoa or ASA24. Further, the investigators will relate dietary determinants of glycemic variability (e.g., percent carbohydrate, fiber intake, etc.), obtained from each dietary assessment tool, to the continuous glucose monitor (CGM)-derived outcomes.
With a randomized block design, this study will take place as part of the Framingham Heart Study (FHS) glucose study (R01 DK129305). Currently participants from the Third Generation-based cohorts are asked at their fourth examination to wear Dexcom G6 Pro continuous glucose monitor on either their arm or abdomen for a duration of at least 4 days. During this time, participants are asked to complete 3 consecutive days of dietary record through ASA24. For this trial, the investigators will randomize the dietary assessment tool weekly between ASA24 and Keenoa, therefore, depending on the week of administration, participants will be randomized to either a 3 days dietary record via ASA24 or a 3-day dietary record through Keenoa. This trial will last a total of 6 weeks.
- Conditions
- Dietary Habits
- Being tested
- Keenoa, ASA24
- Keywords
- Web-based dietary recalls, Automatic Self-Administered 24-Hour Dietary Assessment Tool, Keenoa, Framingham Heart Study cohort
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeenoaOther
Keenoa is an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data. Serving as a visual food diary, individuals can upload a picture of their meal, choose the food items eaten using a preselected food list available by the app, and confirm the portion size with the presented visual aids.
ASA24Other
The Automated Self-Administered 24-Hour (ASA24) dietary recall or record is a free, web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.
| Study group | Role | What they receive |
|---|---|---|
| Keenoa | Experimental | Participants randomized to this arm will document a 3-day dietary assessment using Keenoa. Receives: Other: Keenoa |
| ASA24 | Active comparator | Participants randomized to this arm will document a 3-day dietary assessment using the web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Receives: Other: ASA24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Dietary Assessment Method
Acceptability will be assessed using a quantitative satisfaction scale (0-5), where 0=not acceptable and 5=very acceptable. Higher scores suggest higher acceptability.
Measured: 6 weeks
Completion of 3 Day Dietary Assessment With >= 600 kcal
This outcome will be assessed by the number and percentage of participants who complete all 3 days of diet assessments with >= 600 kcal. The higher the percentage the greater the completion rate.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jul 2024
- Primary completion28 Aug 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized block design will be implemented.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole L Spartano, PhD, Principal investigator, BU Chobanian & Avedisian School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455111
- Sponsor's protocol ID
- H-41743
- Other IDs
- R01DK129305
- Status last verified
- Aug 2025
- First submitted
- 7 Jun 2024
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study: A Block Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06455111
- Acronym / sponsor ID
- H-41743
- Conditions
- Dietary Habits
- Keywords
- Web-based dietary recalls, Automatic Self-Administered 24-Hour Dietary Assessment Tool, Keenoa, Framingham Heart Study cohort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Further utilizing food recognition technologies to capture real-time food intake may aid in overcoming limitations of existing methods. Keenoa, an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data.
Primarily, the investigators will assess acceptability and usability of Keenoa compared with the traditional, web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in the Framingham Heart Study Third Generation-based cohorts at examination 4. The investigators will also determine the proportion of participants who complete all three days of dietary assessment, either through Keenoa or ASA24. Further, the investigators will relate dietary determinants of glycemic variability (e.g., percent carbohydrate, fiber intake, etc.), obtained from each dietary assessment tool, to the continuous glucose monitor (CGM)-derived outcomes.
With a randomized block design, this study will take place as part of the Framingham Heart Study (FHS) glucose study (R01 DK129305). Currently participants from the Third Generation-based cohorts are asked at their fourth examination to wear Dexcom G6 Pro continuous glucose monitor on either their arm or abdomen for a duration of at least 4 days. During this time, participants are asked to complete 3 consecutive days of dietary record through ASA24. For this trial, the investigators will randomize the dietary assessment tool weekly between ASA24 and Keenoa, therefore, depending on the week of administration, participants will be randomized to either a 3 days dietary record via ASA24 or a 3-day dietary record through Keenoa. This trial will last a total of 6 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized block design will be implemented.
| Arm | Type | Receives |
|---|---|---|
| Keenoa | Experimental | Other: KeenoaParticipants randomized to this arm will document a 3-day dietary assessment using Keenoa. |
| ASA24 | Active comparator | Other: ASA24Participants randomized to this arm will document a 3-day dietary assessment using the web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- FHS participants from the Gen 3 cohort who will attend the Exam 4 cycle
Key exclusion criteria (1 listed)
- Participants with cognitive impairment which may prevent them from being able to complete diet records and follow instructions for continuous glucose monitor device wear.
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 |
|---|---|---|
| KeenoaKeenoa is an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data. Serving as a visual food diary, individuals can upload a picture of their meal, choose the food items eaten using a preselected food list available by the app, and confirm the portion size with the presented visual aids. | Other | Keenoa |
| ASA24The Automated Self-Administered 24-Hour (ASA24) dietary recall or record is a free, web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. | Other | ASA24 |
Primary outcome
Acceptability of Dietary Assessment Method
Time frame: 6 weeks
Acceptability will be assessed using a quantitative satisfaction scale (0-5), where 0=not acceptable and 5=very acceptable. Higher scores suggest higher acceptability.
Completion of 3 Day Dietary Assessment With >= 600 kcal
Time frame: 6 weeks
This outcome will be assessed by the number and percentage of participants who complete all 3 days of diet assessments with >= 600 kcal. The higher the percentage the greater the completion rate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Dietary Habits
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.
Nicole L Spartano, PhD principal investigator
BU Chobanian & Avedisian School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keenoa and ASA24 in people with Dietary Habits, run by Boston University 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 1 inclusion and 1 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 13 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability of Dietary Assessment Method (time frame: 6 weeks). The study lists 2 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 13 Aug 2025.