Validation of a Digital Visual Analogue Scale for Appetite Measurement

Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study

The objective of the study is to validate a newly developed digital visual analog scales with a mobile app for measuring human appetite and compare it with a traditional paper-based visual analog scales for appetite measurement.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Breakfast meal

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55427
      • Remote study, no physical facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults 18-70 years.
• Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
• Understand the study procedures.
• Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
• Willing to follow study procedures on test days.
• Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.
• Willing to provide informed consent to participate in the study.

Exclusion Criteria:

• Pregnant or lactating women, or women who are planning to become pregnant during the study
• Known food allergies, sensitivity, or intolerance to any food or food ingredients
• Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
• Taking medications that affect appetite, metabolism, or blood pressure
• Presence of acute diseases or infection
• Presence or history of chronic diseases
• Diagnosed with eating disorders
• Restraint eaters
• Lost or gained 5 pounds or more in the past 3 months
• On a weight-loss diet, or undergoing intermittent fasting
• COVID-19 infection in the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breakfast meal with 460 kcal	Other: Breakfast meal; A meal consisting of breakfast biscuits and water.
Active Comparator: Breakfast meal with 230 kcal	Other: Breakfast meal; A meal consisting of breakfast biscuits and water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve for Hunger 0-240 min	Area Under the Curve for Hunger 0-240 min	0-240 min
Area Under the Curve for Fullness 0-240 min	Area Under the Curve for Fullness 0-240 min	0-240 min
Area Under the Curve for Desire to Eat 0-240 min	Area Under the Curve for Desire to Eat 0-240 min	0-240 min
Area Under the Curve for Prospective Consumption 0-240 min	Area Under the Curve for Prospective Consumption 0-240 min	0-240 min
Area Under the Curve for Satiety 0-240 min	Area Under the Curve for Satiety 0-240 min	0-240 min

Collaborators and Investigators

• Sponsor: General Mills

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022/03/11

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