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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06266533
Other study ID # Pro2023002473
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 21, 2024
Est. completion date July 1, 2024

Study information

Verified date March 2024
Source Rutgers, The State University of New Jersey
Contact Pamela Rothpletz-Puglia, EdD
Phone (973)972-8393
Email pr.puglia@shp.rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 education about ultra-processed food.


Description:

1. 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. 2. 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. 3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Conventional Ultra-processed Food Nutrition Education
The participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion.
Arts-based Ultra-processed Food Nutrition Education
The participants will receive an arts-based nutrition education session with video, animation, music, and discussion.

Locations

Country Name City State
United States Leaguers Inc. Head Start Newark New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 60 minutes
Primary 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. 6 months
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