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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05432271
Other study ID # 850263
Secondary ID R01DK113307
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2022
Est. completion date December 3, 2022

Study information

Verified date December 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the impact of 5 different types of front of package (FOP) food and beverage labels: 1) calorie labels [control], 2) green labels on healthy foods, 3) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 4) physical activity calorie equivalent labels, and 5) "High in" nutrient warning labels) on consumers' beverage and snack selections.


Description:

This project involves an online randomized experiment. We are working with an external survey company that will recruit 8,000 participants to complete an online survey in which they will be randomized to one of the five different label conditions: 1) calorie labels (control condition); 2) single green traffic light labels (on healthy foods); 3) multiple traffic light labels (red traffic light labels applied to less healthy foods, yellow applied to moderately healthy foods, and green on healthy foods); 4) physical activity labels (calorie content displayed in terms of physical activity equivalents); 5) "High in" warnings (applied to all products exceeding thresholds for calories, saturated fat, sugar, or sodium content). Participants will be instructed to select products to purchase in a mock vending machine. After purchasing their products, they will be asked to answer questions about their perceptions of the different labels.


Recruitment information / eligibility

Status Completed
Enrollment 8145
Est. completion date December 3, 2022
Est. primary completion date December 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants will be US adults - Ages 18 or older - With an over-sample of adults with lower educational attainment (some college or less) Exclusion Criteria: - Younger than 18 - Non-US - Educational quota filled

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure to calorie information
Calories for all beverages and foods
Exposure to healthy labels only
Green labels only for beverages and foods scored as healthy
Exposure to healthiness information
All beverages and foods labeled as either healthy (green), moderately healthy (yellow), or less healthy (red)
Exposure to physical activity equivalents
All beverages and foods labeled with physical activity required to burn their calories
Exposure to "high in" nutrient warning labels
Warning labels only for beverages and foods that exceed the thresholds for sugar, sodium, saturated fat, or calorie content

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Purchasing Beverages With Calories Participants will select a beverage to purchase from the online vending machine. Outcome is binary: purchased a beverage with calories or not. The survey will take up to 20 minutes.
Primary Calories Purchased From Beverages, if Beverage With Calories Chosen Participants will select a beverage to purchase from the online vending machine. Outcome is calories in beverage chosen to purchase - only for those participants who chose a beverage with calories. The survey will take up to 20 minutes.
Primary Calories Purchased From Snacks Participants will select a snack to purchase from the online vending machine. Outcome is calories in snacks chosen to purchase. The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Healthy Beverage Participants will select a beverage to purchase in the virtual store. Outcome is percentage of people selecting a healthy beverage (green labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Moderately Healthy Beverage Participants will select a beverage to purchase in the virtual store. Outcome is percentage of people selecting a moderately healthy beverage (yellow labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Less Healthy Beverage Participants will select a beverage to purchase in the virtual store. Outcome is percentage of people selecting a less healthy beverage (red labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Healthy Snack Participants will select a snack to purchase in the virtual store. Outcome is percentage of people selecting a healthy snack (green labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Moderately Healthy Snack Participants will select a snack to purchase in the virtual store. Outcome is percentage of people selecting a moderately healthy snack (yellow labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Likelihood of Selecting a Less Healthy Snack Participants will select a snack to purchase in the virtual store. Outcome is percentage of people selecting a less healthy snack (red labeled in the traffic light condition) The survey will take up to 20 minutes.
Secondary Saturated Fat Purchased From Beverages Participants will select a beverage to purchase from the online vending machine. Outcome is saturated fat in beverage chosen to purchase. The survey will take up to 20 minutes.
Secondary Sodium Purchased From Beverages Participants will select a beverage to purchase from the online vending machine. Outcome is sodium in beverage chosen to purchase. The survey will take up to 20 minutes.
Secondary Total Sugar Purchased From Beverages Participants will select a beverage to purchase from the online vending machine. Outcome is total sugar in beverage chosen to purchase. The survey will take up to 20 minutes.
Secondary Saturated Fat Purchased From Snacks Participants will select a snack to purchase from the online vending machine. Outcome is saturated fat in snack chosen to purchase. The survey will take up to 20 minutes.
Secondary Sodium Purchased From Snacks Participants will select a snack to purchase from the online vending machine. Outcome is sodium in snack chosen to purchase. The survey will take up to 20 minutes.
Secondary Total Sugar Purchased From Snacks Participants will select a snack to purchase from the online vending machine. Outcome is total sugar in snack chosen to purchase. The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Healthy Beverage This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Moderately Healthy Beverage This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Less Healthy Beverage This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Healthy Snack This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Moderately Healthy Snack This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Perceived Healthiness of a Less Healthy Snack This variable will be measured on a 5-point Likert scale ranging from "very unhealthy" to "very healthy". The survey will take up to 20 minutes.
Secondary Noticing Trial Labels Participants will respond "yes," "no," or "not sure" to the item: "When you were selecting a beverage and a snack, did you notice any other nutrition labels on or next to the products?" The survey will take up to 20 minutes.
Secondary Degree of Perceived Label Influence on Beverage Selection Participants will respond on a 5-point scale ranging from "Not at all" to "A great deal" to the item: "How much did you use this label to help you decide what beverage to buy?" The survey will take up to 20 minutes.
Secondary Degree of Perceived Label Influence on Snack Selection Participants will respond on a 5-point scale ranging from "Not at all" to "A great deal" to the item: "How much did you use this label to help you decide what snack to buy?" The survey will take up to 20 minutes.
Secondary Trust in Labels Item: "How much do you trust or distrust the information on this label?". Responses will be measured on a 5-point Likert scale from "completely distrust" to "completely trust". The survey will take up to 20 minutes.
Secondary Reactance to Labels We will examine the average reactance to the label (said the label is trying to manipulate me, or annoys me). Each reactance item will be scored on a 5-pt likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Attention to Labels Item: "How much does this label grab your attention?". Responses will be measured on a 5-point Likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Learned From Labels Item: "To what extent did you learn something new from this label?". Responses will be measured on a 5-point Likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Thinking About Health Effects Item: "How much does this label make you think about the health effects of food and beverages?". Responses will be measured on a 5-point Likert scale from "not at all" to "a great deal" The survey will take up to 20 minutes.
Secondary Perceived Discouragement We will examine if they said the label discourages them from choosing unhealthy products. This item will be scored on a 5-pt likert scale from "not at all" to "a great deal" The survey will take up to 20 minutes.
Secondary Perceived Encouragement We will examine if they said the label encourages them to choose healthy products. This item will be scored on a 5-pt likert scale from "not at all" to "a great deal" The survey will take up to 20 minutes.
Secondary Negative Emotional Reactions We will examine the average negative emotional response to the label (said the label made them feel worried, scared, guilty, ashamed, or sad). Each emotion will be scored on a 5-pt likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Perceived Control in Response to Labels Participants will respond to the item "Overall does this label make you feel…" with one of 3 responses: "less in control of making healthy eating decisions", "more in control of healthy eating decisions", or "neither less nor more in control of making healthy eating decisions" The survey will take up to 20 minutes.
Secondary Perceived Personal Stigmatization Participants will respond to the item "How personally stigmatized does this label make you feel?" on a 5-pt likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Perceived Obesity Stigma We will examine the average stigma response to the label (the label stigmatizes people with obesity, the label increases blame toward people for being overweight). Each stigma item will be scored on a 5-pt likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
Secondary Disgust Toward People With Obesity Participants will respond to the item "How disgusted do people with obesity make you feel?" on a 5-pt likert scale from "not at all" to "a great deal". The survey will take up to 20 minutes.
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