Dietary Habits
Conditions
Keywords
Web-based dietary recalls, Automatic Self-Administered 24-Hour Dietary Assessment Tool, Keenoa, Framingham Heart Study cohort
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.
Interventions
OTHERKeenoa
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.
OTHERASA24
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A randomized block design will be implemented.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Dietary Assessment Method | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| 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. | 51 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 11 | 4 |
Baseline characteristics
| Characteristic | Keenoa | ASA24 | Total |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 7.9 | 58.4 years STANDARD_DEVIATION 9 | 58.1 years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized Hispanic/Latino | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hon-Hispanic White | 59 Participants | 47 Participants | 106 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Multiracial | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic Unknown Race | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 64 participants | 51 participants | 115 participants |
| Sex: Female, Male Female | 35 Participants | 27 Participants | 62 Participants |
| Sex: Female, Male Male | 29 Participants | 24 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 47 |
| other Total, other adverse events | 0 / 53 | 0 / 47 |
| serious Total, serious adverse events | 0 / 53 | 0 / 47 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: 38 participants in the Keenoa group and 27 participants in the ASA24 group provided answers about acceptability used to analyze this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Keenoa | Acceptability of Dietary Assessment Method | 3.3 units on a scale | Standard Deviation 1.1 |
| ASA24 | Acceptability of Dietary Assessment Method | 3.1 units on a scale | Standard Deviation 0.99 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Keenoa | Completion of 3 Day Dietary Assessment With >= 600 kcal | 23 Participants |
| ASA24 | Completion of 3 Day Dietary Assessment With >= 600 kcal | 27 Participants |