Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study

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.

Study Overview

• Status: Completed
• Conditions: Dietary Habits
• Intervention / Treatment: Other: Keenoa; Other: ASA24

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • BU Chobanian & Avedisian School of Medicine, Framingham Heart Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• FHS participants from the Gen 3 cohort who will attend the Exam 4 cycle

Exclusion Criteria:

• Participants with cognitive impairment which may prevent them from being able to complete diet records and follow instructions for continuous glucose monitor device wear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keenoa; Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nicole L Spartano, PhD, BU Chobanian & Avedisian School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Web-based dietary recalls; Automatic Self-Administered 24-Hour Dietary Assessment Tool; Keenoa; Framingham Heart Study cohort
• Other Study ID Numbers: H-41743; R01DK129305 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No