Obesity, AdolescentNCT04905498
Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making
A study testing Commercial Advertising Literacy Training in people with Obesity, Adolescent, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how food commercials influence food choices in children and their parents. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Commercial Advertising Literacy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 7 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Developmental Decision Making Study
The purpose of this study is to evaluate how food commercials influence food choices in children and their parents.
Read the 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.
- Conditions
- Obesity, Adolescent
- Being tested
- Commercial Advertising Literacy Training, Control
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial Advertising Literacy TrainingBehavioural
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."
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Children were exposed to food commercials without narratives. Receives: Behavioral: Control |
| Intervention | Experimental | Children were exposed to narrative statements that were shown and read aloud in between commercials played. Receives: Behavioral: Commercial Advertising Literacy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Choice Change
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.
Measured: Pre (day 0) and post intervention (day 7-10).
Food Tastiness Change
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.
Measured: Pre (day 0) and post intervention (day 7-10).
Food Health Change
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.
Measured: Pre (day 0) and post intervention (day 7-10).
Secondary outcomes (1)
Level of Self-Control, as Measured by the Self-Control Scale
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.
Measured: Children completed this item at the baseline visit (pre intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start7 Jan 2019
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Missouri, Kansas City
- Responsible party
- Sponsor
- Investigators
- Amanda S Bruce, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905498
- Sponsor's protocol ID
- STUDY00003631
- Other IDs
- 8UG1OD024943-02
- Status last verified
- Mar 2023
- First submitted
- 24 May 2021
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha OR, Killian HJ, Davis AM, Lim SL, Bruce JM, Sotos JJ, Nelson SC, Bruce AS. Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making. Front Psychol. 2020 Dec 2;11:599663. doi: 10.3389/fpsyg.2020.599663. eCollection 2020.
PubMed 33343472
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Decision Making Study
- ClinicalTrials.gov ID
- NCT04905498
- Acronym / sponsor ID
- STUDY00003631
- Conditions
- Obesity, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Missouri, Kansas City
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how food commercials influence food choices in children and their parents.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlChildren were exposed to food commercials without narratives. |
| Intervention | Experimental | Behavioral: Commercial Advertising Literacy TrainingChildren were exposed to narrative statements that were shown and read aloud in between commercials played. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial Advertising Literacy TrainingChildren 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." | Behavioural | Intervention |
| ControlChildren 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. | Behavioural | Control |
Primary outcome
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.
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.
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.
1 secondary outcome
Level of Self-Control, as Measured by the Self-Control Scale
Time frame: Children completed this item at the baseline visit (pre intervention).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33343472Ha OR, Killian HJ, Davis AM, Lim SL, Bruce JM, Sotos JJ, Nelson SC, Bruce AS. Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making. Front Psychol. 2020 Dec 2;11:599663. doi: 10.3389/fpsyg.2020.599663. eCollection 2020.
- FrontiersLink provided by the sponsor.
- PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda S Bruce, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial Advertising Literacy Training in people with Obesity, Adolescent, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Choice Change (time frame: Pre (day 0) and post intervention (day 7-10).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.