Trial Outcomes & Findings for Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study (NCT NCT06455111)
NCT ID: NCT06455111
Last Updated: 2025-08-13
Results Overview
Acceptability will be assessed using a quantitative satisfaction scale (0-5), where 0=not acceptable and 5=very acceptable. Higher scores suggest higher acceptability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-08-13
Participant Flow
Participant milestones
| Measure |
Keenoa
Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.
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.
|
ASA24
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.
ASA24: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
51
|
|
Overall Study
COMPLETED
|
53
|
47
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
Keenoa
Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.
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.
|
ASA24
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.
ASA24: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
4
|
Baseline Characteristics
Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study
Baseline characteristics by cohort
| Measure |
Keenoa
n=64 Participants
Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.
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.
|
ASA24
n=51 Participants
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.
ASA24: 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.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hon-Hispanic White
|
59 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Multiracial
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Unknown Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
51 participants
n=7 Participants
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 38 participants in the Keenoa group and 27 participants in the ASA24 group provided answers about acceptability used to analyze this outcome measure.
Acceptability will be assessed using a quantitative satisfaction scale (0-5), where 0=not acceptable and 5=very acceptable. Higher scores suggest higher acceptability.
Outcome measures
| Measure |
Keenoa
n=38 Participants
Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.
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.
|
ASA24
n=27 Participants
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.
ASA24: 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.
|
|---|---|---|
|
Acceptability of Dietary Assessment Method
|
3.3 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 0.99
|
PRIMARY outcome
Timeframe: 6 weeksThis 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.
Outcome measures
| Measure |
Keenoa
n=53 Participants
Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.
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.
|
ASA24
n=47 Participants
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.
ASA24: 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.
|
|---|---|---|
|
Completion of 3 Day Dietary Assessment With >= 600 kcal
|
23 Participants
|
27 Participants
|
Adverse Events
Keenoa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ASA24
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicole L Spartano, PhD
Boston University School of Medicine Endocrinology, Diabetes, Nutrition & Weight Management
Phone: 315-415-2040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place