NCT06266533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 24, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

February 5, 2024

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Conventional Nutrition Education

ACTIVE COMPARATOR

Conventional nutrition education

Behavioral: Conventional Ultra-processed Food Nutrition Education

Arts-based Nutrition Education

EXPERIMENTAL

Arts-based nutrition education video production

Behavioral: Arts-based Ultra-processed Food Nutrition Education

Interventions

The participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion.

Conventional Nutrition Education

The participants will receive an arts-based nutrition education session with video, animation, music, and discussion.

Arts-based Nutrition Education

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Spanish-speaking
  • Other racial and ethnic groups
  • Fathers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leaguers Inc. Head Start

Newark, New Jersey, 07102, United States

Location

Related Publications (3)

  • 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.

    PMID: 35564081BACKGROUND
  • 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.

    PMID: 31850537BACKGROUND
  • 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.

    PMID: 25326092BACKGROUND

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Pamela Rothpletz-Puglia, EdD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to a conventional nutrition education or an arts-based education group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 20, 2024

Study Start

February 21, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations