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| ID | Type | Description | Link |
|---|---|---|---|
| 25ISA1474935 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| International Food Policy Research Institute | OTHER |
| Penn State University | OTHER |
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The goal of this feasibility study is to determine the adherence, acceptability, and usability of the behavioral intervention of a mobile AI application and its effects on food choices and diet quality. A secondary goal is to assess whether the app's accuracy or feasibility differs by food security status. Study participants are UC Davis students aged 18-24 years. The main question it aims to answer is:
- Does the gamified app version that delivers behavioral nudges have a higher adherence and acceptability rate, and does this translate to better dietary behaviors?
Participants will use either the intervention app (dietary assessment + gamification) or the control app (non-gamified, dietary assessment only) for six weeks to record all their food intake. Diet quality will be assessed at baseline and endline, and a Likert scale acceptability questionnaire will be administered at endline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group- Gamified app version; dietary assessment + gamification | Experimental | Participants will be randomly assigned at enrollment to the intervention group, which will receive a gamified app that delivers behavioral nudges and provides a daily report of caloric and nutrient intake. |
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| Control group- Limited app version, dietary assessment only | Active Comparator | Participants will be randomized at enrollment to the control group, which will receive a "limited" app version that only provides a daily report of caloric and nutrient intake, without delivering behavioral nudges. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A mobile application that uses AI to deliver behavioral nudges that encourage healthy food choices. | Other | As a mobile application for assessing dietary intake, the app provides a daily report of food intake- a core function that both the gamified and limited app versions have. The gamified version has the added functionality of delivering behavioral nudges that encourage healthy food selections. |
| Measure | Description | Time Frame |
|---|---|---|
| App acceptability by version assigned to participants | Acceptability will be assessed using a structured questionnaire based on a Likert scale from 1 (strongly agree) to 5 (strongly disagree) administered at the end of the study period. | Measured at endline: at the end of the 6 week period |
| App's usability by version assigned to participants | Focus group discussions will be conducted with a select group of participants to assess usability (i.e. facilitators and barriers to app usage) at the end of the study period. | Measured at endline: at the end of the 6 week period |
| App adherence rates by version assigned to participants | App usage adherence will be evaluated based on analytics data, with a 70% usage threshold defined for both the midline and endline assessments. | Assessed at midline (3 weeks) and endline (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Diet quality assessment by app version, measured using Healthy Eating Index scores at baseline and endline. | Determine changes in diet quality by app version. The Healthy Eating Index is scored from 0-100. The higher the score, the better the alignment of a diet with key recommendations in the Dietary Guidelines for Americans. | From enrollment till study completion at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christabel A Domfe, MS | Contact | 530-752-4630 | cadomfe@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren E Au, PhD, RDN | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis - Department of Nutrition | Davis | California | 95616 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2025 | Jul 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Pilot RCT | Jun 4, 2025 | Jul 8, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Validation study | Jun 4, 2025 | Jul 8, 2025 | ICF_002.pdf |
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| Limited app version for dietary assessment only | Other | This app version provides a daily report of energy and nutrient intake- available to those randomized to the control group |
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| App usability by food security status assessed using the USDA 10-item food security survey module | The validated USDA 10-item Food Security Survey Module will be used to capture food security over the prior 12 months and be administered at the recruitment visit. Moderation of app's usability by food security status will be assessed by including an interaction term between the app version and food security strata. Food security status is assigned as follows- Raw score zero: High food security; Raw score 1-2: Marginal food security; Raw score 3-5: Low food security; Raw score 6-10:Very low food security. | Food security assessed at baseline |
| App acceptability by food security status assessed using the USDA 10-item food security survey module | The validated USDA 10-item Food Security Survey Module will be used to capture food security over the prior 12 months and be administered at the recruitment visit. Moderation of app's acceptability by food security status will be assessed by including an interaction term between the app version and food security strata. Food security status is assigned as follows- Raw score zero: High food security; Raw score 1-2: Marginal food security; Raw score 3-5: Low food security; Raw score 6-10:Very low food security. | Food security assessed at baseline |
| App adherence rates by food security status assessed using the USDA 10-item food security survey module | The validated USDA 10-item Food Security Survey Module will be used to capture food security over the prior 12 months and be administered at the recruitment visit. Moderation of app's adherence rates by food security status will be assessed by including an interaction term between the app version and food security strata. Food security status is assigned as follows- Raw score zero: High food security; Raw score 1-2: Marginal food security; Raw score 3-5: Low food security; Raw score 6-10:Very low food security. | Food security assessed at baseline |