Food SelectionNCT06266533
Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)
A study testing Conventional Ultra-processed Food Nutrition Education and Arts-based Ultra-processed Food Nutrition Education in people with Food Selection and Environmental Exposure, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Selection, Environmental Exposure
- What is being tested?
- Conventional Ultra-processed Food Nutrition Education and Arts-based Ultra-processed Food Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- African American or Black or bi-racial or multi-racial African American and Black mothers
- >18 years
- Female
- Legal guardian of a preschool-age child (3-5 years) participating in the Leaguers, Inc.
- Head Start programming.
Who cannot join
- Spanish-speaking
- Other racial and ethnic groups
- Fathers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dismantling the U.S. Social Norm of the "Kids' Food" Archetype That Includes Ultra-processed Foods Such as Chicken Nuggets and Fries in the Newark, NJ Community
This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.
Read the detailed description
- At baseline, describe how mothers of preschool-age children characterize food for children in their home and local environment and describe their knowledge of ultra-processed food.
- To test different ways of providing nutrition education for increasing knowledge about children's nutrition and ultra-processed foods. Hypothesis: Both groups will correctly identify more ultra-processed foods post-education.
- To learn in depth from mothers of preschool children about their perceptions of the food environmental culture (markets, advertising, health messaging, community norms, cultural norms, social norms) in Newark, NJ, through a series of focus group discussions about the mothers' photographs of the local food environment pre and post project.
- Conditions
- Food Selection, Environmental Exposure
- Being tested
- Conventional Ultra-processed Food Nutrition Education, Arts-based Ultra-processed Food Nutrition Education
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Ultra-processed Food Nutrition EducationBehavioural
The participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion.
Arts-based Ultra-processed Food Nutrition EducationBehavioural
The participants will receive an arts-based nutrition education session with video, animation, music, and discussion.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Nutrition Education | Active comparator | Conventional nutrition education Receives: Behavioral: Conventional Ultra-processed Food Nutrition Education |
| Arts-based Nutrition Education | Experimental | Arts-based nutrition education video production Receives: Behavioral: Arts-based Ultra-processed Food Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultra-Processed Food Knowledge
Participants will classify pictures of foods as ultra-processed or whole foods (adapted from Sarmiento-Santos, cited below) and as healthy or unhealthy. on a Pre and post-ultra-processed food knowledge questionnaire. Both sets of questions are yes or no categorical questions.
Measured: 60 minutes
Environmental assessment of ultra-processed food
Participant photographs of the local food environment. At two time points (pre and post educational intervention) participants will take photographs of the local food environment including grocery stores, restaurant menus, etc. The purpose of this is to learn from participants about how they perceive the local kids' food environment and if they observe differences after the intervention. Photo elicitation techniques will be used during a series of focus groups for participants to discuss the photographs they took. These data will be analyzed using a layered analysis of the photographs (appraisal, discussion with participant who took the photo, cross-photo comparison, and interpretation) pre and post educational intervention, and thematic analysis of the focus group transcripts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start21 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to a conventional nutrition education or an arts-based education group.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Rothpletz-Puglia, EdD, RD, Rutgers, The State University of New Jersey
- Investigators
- Pamela Rothpletz-Puglia, EdD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266533
- Sponsor's protocol ID
- Pro2023002473
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarmiento-Santos J, Souza MBN, Araujo LS, Pion JMV, Carvalho RA, Vanin FM. Consumers' Understanding of Ultra-Processed Foods. Foods. 2022 May 7;11(9):1359. doi: 10.3390/foods11091359.
PubMed 35564081Andreassen P, Christensen MK, Moller JE. Focused ethnography as an approach in medical education research. Med Educ. 2020 Apr;54(4):296-302. doi: 10.1111/medu.14045. Epub 2020 Feb 16.
PubMed 31850537Braun V, Clarke V. What can "thematic analysis" offer health and wellbeing researchers? Int J Qual Stud Health Well-being. 2014 Oct 16;9:26152. doi: 10.3402/qhw.v9.26152. eCollection 2014. No abstract available.
PubMed 25326092
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dismantling the U.S. Social Norm of the "Kids' Food" Archetype That Includes Ultra-processed Foods Such as Chicken Nuggets and Fries in the Newark, NJ Community
- ClinicalTrials.gov ID
- NCT06266533
- Acronym / sponsor ID
- Pro2023002473
- Conditions
- Food Selection, Environmental Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.
Detailed description
- At baseline, describe how mothers of preschool-age children characterize food for children in their home and local environment and describe their knowledge of ultra-processed food.
- To test different ways of providing nutrition education for increasing knowledge about children's nutrition and ultra-processed foods. Hypothesis: Both groups will correctly identify more ultra-processed foods post-education.
- To learn in depth from mothers of preschool children about their perceptions of the food environmental culture (markets, advertising, health messaging, community norms, cultural norms, social norms) in Newark, NJ, through a series of focus group discussions about the mothers' photographs of the local food environment pre and post project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to a conventional nutrition education or an arts-based education group.
| Arm | Type | Receives |
|---|---|---|
| Conventional Nutrition Education | Active comparator | Behavioral: Conventional Ultra-processed Food Nutrition EducationConventional nutrition education |
| Arts-based Nutrition Education | Experimental | Behavioral: Arts-based Ultra-processed Food Nutrition EducationArts-based nutrition education video production |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- African American or Black or bi-racial or multi-racial African American and Black mothers
- >18 years
- Female
- Legal guardian of a preschool-age child (3-5 years) participating in the Leaguers, Inc.
Key exclusion criteria (3 listed)
- Spanish-speaking
- Other racial and ethnic groups
- Fathers
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 |
|---|---|---|
| Conventional Ultra-processed Food Nutrition EducationThe participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion. | Behavioural | Conventional Nutrition Education |
| Arts-based Ultra-processed Food Nutrition EducationThe participants will receive an arts-based nutrition education session with video, animation, music, and discussion. | Behavioural | Arts-based Nutrition Education |
Primary outcome
Ultra-Processed Food Knowledge
Time frame: 60 minutes
Participants will classify pictures of foods as ultra-processed or whole foods (adapted from Sarmiento-Santos, cited below) and as healthy or unhealthy. on a Pre and post-ultra-processed food knowledge questionnaire. Both sets of questions are yes or no categorical questions.
Environmental assessment of ultra-processed food
Time frame: 6 months
Participant photographs of the local food environment. At two time points (pre and post educational intervention) participants will take photographs of the local food environment including grocery stores, restaurant menus, etc. The purpose of this is to learn from participants about how they perceive the local kids' food environment and if they observe differences after the intervention. Photo elicitation techniques will be used during a series of focus groups for participants to discuss the photographs they took. These data will be analyzed using a layered analysis of the photographs (appraisal, discussion with participant who took the photo, cross-photo comparison, and interpretation) pre and post educational intervention, and thematic analysis of the focus group transcripts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 35564081Sarmiento-Santos J, Souza MBN, Araujo LS, Pion JMV, Carvalho RA, Vanin FM. Consumers' Understanding of Ultra-Processed Foods. Foods. 2022 May 7;11(9):1359. doi: 10.3390/foods11091359.
- Background: PubMed 31850537Andreassen P, Christensen MK, Moller JE. Focused ethnography as an approach in medical education research. Med Educ. 2020 Apr;54(4):296-302. doi: 10.1111/medu.14045. Epub 2020 Feb 16.
- Background: PubMed 25326092Braun V, Clarke V. What can "thematic analysis" offer health and wellbeing researchers? Int J Qual Stud Health Well-being. 2014 Oct 16;9:26152. doi: 10.3402/qhw.v9.26152. eCollection 2014. No abstract available.
- 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.
Pamela Rothpletz-Puglia, EdD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Ultra-processed Food Nutrition Education and Arts-based Ultra-processed Food Nutrition Education in people with Food Selection and Environmental Exposure, run by Rutgers, The State University of New Jersey 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 6 inclusion and 3 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 24 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultra-Processed Food Knowledge (time frame: 60 minutes). The study lists 2 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 NCT06266533, which also lists 3 linked publications.
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 24 Jul 2025.