Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making

March 28, 2023 updated by: University of Kansas Medical Center

Developmental Decision Making Study

The purpose of this study is to evaluate how food commercials influence food choices in children and their parents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed research will investigate food decision-making in youth. Childhood obesity is a risk factor for health issues, thus preventing adverse effects of childhood obesity by promoting healthy eating habits and providing effective interventions are important. Television food commercials advertising calorie-dense and high in salt and sugar foods are known to contribute unhealthy food choices and obesity. Thus the proposed study will examine how the advertising intervention focusing on increasing advertising knowledge and changing affective attitudes toward commercials impacts susceptability to commercials and food decisions in youth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children had to be between 8-12.9 years old (including 8 year olds, NOT including 13 year olds.
  • Had to be able to speak English as their primary language.
  • Self-reported normal hearing and vision.

Exclusion Criteria:

  • Did not speak English
  • Data from children with history of neurological conditions, clinically significant psychopathology, or learning disabilities reported by parents (e.g., Attention Deficit Hyperactivity Disorder, depression) will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Children were exposed to food commercials without narratives.
Behavioral: Control
Children were shown food commercials that were the same length as the other group but did not receive any information about whether the content was truthful.
Experimental: Intervention
Children were exposed to narrative statements that were shown and read aloud in between commercials played.
Behavioral: Commercial Advertising Literacy Training
Children were shown food commercials and in between those commercials they saw and heard statements such as "These foods won't make you happy" and "Those foods are so unhealthy."

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Food Choice Change
Time Frame: Pre (day 0) and post intervention (day 7-10).
Children rated on a 4-point Likert scale (1-Strong No, 2-No, 3-Yes, 4-Strong Yes) about whether they would choose to eat 60 different foods (30 unhealthy, 30 healthy) on a computer program. Higher values for unhealthy foods represented unhealthier food choices and higher values for healthy foods represented healthier food choices. The mean scores for unhealthy food choices were compared between pre- and post-intervention, and the mean scores for healthy food choices were compared between pre- and post-intervention.
Pre (day 0) and post intervention (day 7-10).
Food Tastiness Change
Time Frame: Pre (day 0) and post intervention (day 7-10).
Children rated on a 4 point Likert scale (1-Very Bad, 2-Bad, 3-Good, 4-Very Good) about how tasty 60 different foods (30 unhealthy, 30 healthy) were on a computer program. A regression coefficient (beta) of food taste was estimated at an individual level by fitting a linear regression model where taste and health ratings predicted food choices for each child. Higher estimated regression coefficients represented higher decision weights of food taste attributes in food choices. The mean estimated regression coefficients were compared between pre- and post-intervention.
Pre (day 0) and post intervention (day 7-10).
Food Health Change
Time Frame: Pre (day 0) and post intervention (day 7-10).
Children rated on a 4 point Likert scale (1-Very Unhealthy, 2-Unhealthy, 3-Healthy, 4-Very Healthy) about how healthy 60 different foods (30 unhealthy, 30 healthy) were on a computer program. A regression coefficient (beta) of food healthiness was estimated at an individual level by fitting a linear regression model where taste and health ratings predicted food choices for each child. Higher estimated regression coefficients represented higher decision weights of food healthiness attributes in food choices. The mean estimated regression coefficients were compared between pre- and post-intervention.
Pre (day 0) and post intervention (day 7-10).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of Self-Control, as Measured by the Self-Control Scale
Time Frame: Children completed this item at the baseline visit (pre intervention).
Children completed the 36-item self-control scale. Each item is rated on a 5-point Likert scale from 1 (not at all like me) to 5 (very much like me). A total score (i.e., 36 response scores were summed) was computed for each child. The total score ranged between 36 (minimum) and 180 (maximum). The higher total score represented higher (better) perceived self-control. No subscales were used.
Children completed this item at the baseline visit (pre intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
University of Missouri, Kansas City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda S Bruce, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003631
  • 8UG1OD024943-02 (U.S. NIH Grant/Contract)

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings