- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329452
Menu to Meal (M2M) Menu Labeling Intervention Study
Menu to Meal (M2M): Evaluating the Effectiveness of a Digital Nutritional Labeling Intervention in Hispanic Restaurant Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description:
This study aims to design and evaluate a culturally tailored, bilingual menu labeling intervention incorporating AR and AI features in small, independently owned Hispanic restaurants. The intervention seeks to promote informed food ordering by targeting psychosocial constructs known to influence food choice. Three sequential conditions will be implemented: (1) baseline with standard menus and no nutrition labels, (2) paper menus with visible bilingual nutrition labels, and (3) a digital AR/AI-enhanced menu.
Guided by the Theory of Planned Behavior and Social Cognitive Theory, the study focuses on constructs such as decision-making confidence, self-efficacy, subjective norms, and perceived behavioral control. The two primary objectives are to (1) develop a culturally informed digital menu labeling tool and (2) evaluate its effectiveness compared with standard and paper menu formats in shaping psychosocial factors and actual ordering behavior.
Participants will be recruited during restaurant visits and exposed to the menu condition corresponding to their visit timing. Surveys will be administered before ordering to assess psychosocial factors, label awareness, and behavioral intentions. A formative needs assessment conducted prior to implementation will ensure cultural and linguistic appropriateness. Findings will provide evidence on the effectiveness of innovative, theory-informed digital interventions in promoting informed food choices in culturally specific restaurant settings not subject to federal nutrition labeling requirements.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyunjung Lee, PhD
- Phone Number: 979-321-7084
- Email: grace.lee@ag.tamu.edu
Study Contact Backup
- Name: Chinanu Gubor, MS
- Email: cggubor@tamu.edu
Study Locations
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Texas
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Bryan, Texas, United States, 77802
- Recruiting
- Local Restaurant Site
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Contact:
- Chinanu Gubor, MS
- Email: cggubor@tamu.edu
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Contact:
- Hyunjung Lee, PhD
- Email: grace.lee@ag.tamu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Patrons dining at participating Hispanic restaurants during designated study hours
- Able to read and speak English or Spanish
- Willing and able to provide informed consent
- Pregnant women are eligible to participate, as the study procedures pose minimal risk
Exclusion Criteria:
- Minors under 18 years of age
- Individuals with visual or cognitive impairments that prevent interaction with the menu formats or AR/AI technology
- Individuals who have participated in a prior phase of the study
- Restaurant staff involved in study implementation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline condition
Standard menu with no nutrition information.
|
|
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Active Comparator: Paper menu condition
Bilingual paper menus display numeric and icon-based nutrition information, including calories, saturated fat, and sodium.
|
Paper menu with bilingual nutrition labels
|
|
Experimental: AR/AI digital menu condition
Mobile app providing interactive nutrition information and personalized guidance based on dietary preferences.
|
AR/AI-enhanced digital menu giving interactive nutrition guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes Toward Healthy Menu Choices
Time Frame: Immediately after the intervention (menu exposure)
|
Attitudes toward selecting healthier menu items, assessed using a study-developed questionnaire informed by the Theory of Planned Behavior. The questionnaire consists of agreement-scale items evaluating whether choosing healthier foods is important, beneficial, and enjoyable. Measurement Tool: Study-developed Attitudes Toward Healthy Menu Choices Questionnaire (5-point agreement Likert scale) Scale Description and Coding:
Unit of Measure: Mean attitude score (range: 1 to 5) Scale Range and Direction: Scores range from 1 to 5. Higher scores indicate more positive attitudes toward choosing healthier menu items. |
Immediately after the intervention (menu exposure)
|
|
Intention to Make Healthier Food Choices
Time Frame: Immediately after the intervention (menu exposure)
|
Intention to choose healthier menu items, assessed using a study-developed questionnaire informed by the Theory of Planned Behavior. Measurement Tool: Study-developed Healthy Eating Intention Questionnaire (5-point agreement Likert scale) Scale Description and Coding:
Unit of Measure: Intention score (range: 1 to 5) Scale Range and Direction: Scores range from 1 to 5. Higher scores indicate stronger intention to choose healthier menu items. |
Immediately after the intervention (menu exposure)
|
|
Perceived Behavioral Control Over Healthy Menu Choices
Time Frame: Immediately after the intervention (menu exposure)
|
Perceived behavioral control over choosing healthier menu items, assessed using a study-developed questionnaire informed by the Theory of Planned Behavior. Measurement Tool: Study-developed Perceived Behavioral Control Questionnaire (5-point agreement Likert scale) Scale Description and Coding:
Unit of Measure: Perceived behavioral control score (range: 1 to 5) Scale Range and Direction: Scores range from 1 to 5. Higher scores indicate greater perceived control over choosing healthier menu items. |
Immediately after the intervention (menu exposure)
|
|
Self-Efficacy for Using Nutrition Information When Ordering
Time Frame: Immediately after the intervention (menu exposure)
|
Self-efficacy for using nutrition information to guide food choices, assessed using a study-developed questionnaire informed by Social Cognitive Theory. Measurement Tool: Study-developed Nutrition Information Self-Efficacy Questionnaire (5-point agreement Likert scale) Scale Description and Coding:
Unit of Measure: Mean self-efficacy score (range: 1 to 5) Scale Range and Direction: Scores range from 1 to 5. Higher scores indicate greater confidence in using nutrition information to make food choices. |
Immediately after the intervention (menu exposure)
|
|
Awareness of Nutrition Information on the Menu
Time Frame: Immediately after the intervention (menu exposure)
|
Awareness of nutrition information on the menu, assessed using a study-developed self-report item asking whether the participant noticed or looked at nutrition information while viewing the menu. Measurement Tool: Study-developed Awareness of Nutrition Information Item (binary response) Scale Description and Coding: 0 = No, did not notice or look at nutrition information 1 = Yes, noticed or looked at nutrition information Unit of Measure: Percentage of participants reporting awareness (response = 1) Scale Range and Direction: Values range from 0 to 1. A value of 1 indicates awareness of nutrition information. How the Percentage Is Derived: The percentage is calculated as the proportion of participants with a response of 1 (Yes) among all participants who completed the questionnaire. |
Immediately after the intervention (menu exposure)
|
|
Use of Nutrition Information to Inform Menu Selection
Time Frame: Immediately after the intervention (menu exposure)
|
Use of nutrition information to inform menu selection, assessed using a study-developed self-report item asking the extent to which nutrition information influenced the participant's food choice. Measurement Tool: Study-developed Nutrition Information Influence Item (5-point Likert scale) Scale Description and Coding:
Unit of Measure: Percentage of participants reporting use of nutrition information, defined as responses of 4 or 5 Scale Range and Direction: Scores range from 1 to 5. Higher values indicate greater influence of nutrition information on choice. How the Percentage Is Derived: The percentage is calculated as the proportion of participants with responses of 4 or 5 among all participants who completed the questionnaire. |
Immediately after the intervention (menu exposure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Energy Ordered per Customer Order
Time Frame: Immediately after the intervention (menu exposure)
|
Total energy content of menu items ordered by each participant, calculated using receipt-based ordering data linked to laboratory-tested and standardized recipe-based nutrient analysis conducted as part of the Menu2Meal (M2M) intervention. Measurement Tool: Receipt-based nutrient calculation using laboratory-tested and standardized nutrient databases Unit of Measure: Mean kilocalories (kcal) per customer order |
Immediately after the intervention (menu exposure)
|
|
Saturated Fat Content of Menu Items Ordered
Time Frame: Immediately after the intervention (menu exposure)
|
Total saturated fat content of menu items ordered by each participant, calculated by summing grams of saturated fat from all items ordered, using laboratory-tested and standardized recipe-based nutrient values. Measurement Tool: Receipt-based nutrient calculation using laboratory-tested and standardized nutrient databases Unit of Measure: Mean grams (g) of saturated fat per customer order |
Immediately after the intervention (menu exposure)
|
|
Sodium Content of Menu Items Ordered
Time Frame: Immediately after the intervention (menu exposure)
|
Total sodium content of menu items ordered by each participant, calculated by summing milligrams of sodium from all items ordered, using laboratory-tested and standardized recipe-based nutrient values. Measurement Tool: Receipt-based nutrient calculation using laboratory-tested and standardized nutrient databases Unit of Measure: Mean milligrams (mg) of sodium per customer order |
Immediately after the intervention (menu exposure)
|
|
Dietary Fiber Content of Menu Items Ordered
Time Frame: Immediately after the intervention (menu exposure)
|
Total dietary fiber content of menu items ordered by each participant, calculated by summing grams of dietary fiber from all items ordered, using laboratory-tested and standardized recipe-based nutrient values. Measurement Tool: Receipt-based nutrient calculation using laboratory-tested and standardized nutrient databases Unit of Measure: Mean grams (g) of dietary fiber per customer order |
Immediately after the intervention (menu exposure)
|
|
Added Sugar Content of Menu Items Ordered
Time Frame: Immediately after the intervention (menu exposure)
|
Total added sugar content of menu items ordered by each participant, calculated by summing grams of added sugars from all items ordered, using laboratory-tested and standardized recipe-based nutrient values. Measurement Tool: Receipt-based nutrient calculation using laboratory-tested and standardized nutrient databases Unit of Measure: Mean grams (g) of added sugars per customer order |
Immediately after the intervention (menu exposure)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyunjung Lee, PhD, Department of Nutrition, Texas A&M University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Saturated fat
- Behavioral intervention
- Health literacy
- Health disparities
- Sodium intake
- Food choice
- Augmented reality (AR)
- Artificial intelligence (AI)
- Dietary behavior
- Digital health intervention
- nutrition labeling
- menu labeling
- Hispanic population
- Chronic disease prevention
- Calorie intake
- Restaurant nutrition
- Theory of Planned Behavior (TPB)
- Social Cognitive Theory (SCT)
- Behavioral Nutrition
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Overweight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Behavior, Animal
- Obesity
- Diabetes Mellitus, Type 2
- Cardiovascular Diseases
- Feeding Behavior
Other Study ID Numbers
- STUDY2025-1204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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