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

NCT06455111 | Completed Results

• 2 other identifiers: H-41743R01DK129305
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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 (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

Keywords

Web-based dietary recalls; Automatic Self-Administered 24-Hour Dietary Assessment Tool; Keenoa; Framingham Heart Study cohort

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Keenoa

EXPERIMENTAL

Participants randomized to this arm will document a 3-day dietary assessment using Keenoa.

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.

Other: ASA24

Interventions

Keenoa OTHER

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.

Keenoa

ASA24 OTHER

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.

ASA24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

BU Chobanian & Avedisian School of Medicine, Framingham Heart Study

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Results Point of Contact

• Title: Nicole L Spartano, PhD
• Organization: Boston University School of Medicine Endocrinology, Diabetes, Nutrition & Weight Management

spartano@bu.edu

315-415-2040

Study Officials

• Nicole L Spartano, PhD

  BU Chobanian & Avedisian School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized block design will be implemented.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion: August 28, 2024
• Study Completion: September 20, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)