- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266533
Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)
July 21, 2025 updated by: Pamela Rothpletz-Puglia, EdD, RD, Rutgers, The State University of New Jersey
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
38
Phase
- 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
-
-
New Jersey
-
Newark, New Jersey, United States, 07102
- Leaguers Inc. Head Start
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Spanish-speaking
- Other racial and ethnic groups
- Fathers
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Nutrition Education
Conventional nutrition education
|
The participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion.
|
|
Experimental: Arts-based Nutrition Education
Arts-based nutrition education video production
|
The participants will receive an arts-based nutrition education session with video, animation, music, and discussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
60 minutes
|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pamela Rothpletz-Puglia, EdD, Rutgers, The State University of New Jersey
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
- 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.
- Andreassen 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.
- Braun 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.
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)
February 21, 2024
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
February 5, 2024
First Submitted That Met QC Criteria
February 12, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
July 24, 2025
Last Update Submitted That Met QC Criteria
July 21, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Pro2023002473
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
product manufactured in and exported from the U.S.
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.
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