Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455111
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-07
Brief Title:
Evaluation of an Artificial Intelligence-Assisted Image-Based Dietary Assessment Tool in the Framingham Heart Study
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Evaluation of an Artificial Intelligence-Assisted Image-Based Dietary Assessment Tool in the Framingham Heart Study A Block Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK129305 | NIH | None | httpsreporternihgovquickSearchR01DK129305 |