NCT05309941

Brief Summary

This randomized controlled trial will assess the effects of External Cues focused messaging (i.e., government recommendations of MyPlate) compared to Internal Cues focused messaging (i.e., intuitive eating). The investigators will collect data on within-person changes in psychological (e.g. affect) and physiological (e.g. heart rate variability) outcomes in female college students. Participants will be randomly assigned to one of two study conditions. In condition one, participants will view a five-minute video focusing on traditional nutrition education principles. In condition two, participants will view a five-minute video focusing on intuitive eating principles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

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

Study Start

First participant enrolled

January 20, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

February 10, 2022

Last Update Submit

October 10, 2023

Conditions

Keywords

nutrition messagingnutrition educationIntuitive Eating

Outcome Measures

Primary Outcomes (2)

  • Change in Heart Rate Variability (HRV)

    Heart rate variability measures the variation in time between each heartbeat. This will be measured using Firstbeat Electrocardiograms (ECGs) that participants will attach to their chest using two electrodes.

    HRV will be measured during a 3-minute baseline period and while watching a 5-minute intervention video.

  • Change in Affect

    Affect will be assessed using the Positive and Negative Affect Schedule (PANAS), an instrument that asks participants to rank the extent to which they are feeling each of 20 different emotions on a scale of 1-5. The PANAS produces a score from 10-50 for each Positive Affect and Negative Affect, with higher scores indicating higher levels of these states.

    The PANAS is administered before and immediately after viewing the video.

Study Arms (2)

Internal Cues Messaging

EXPERIMENTAL

Participants will view a five-minute video focusing on intuitive eating principles.

Other: Internal Cues Nutrition Messaging

External Cues Messaging

ACTIVE COMPARATOR

Participants will view a five-minute video focusing on traditional nutrition education principles.

Other: External Cues Nutrition Messaging

Interventions

Participants will view a 5 minute nutrition education video focused on intuitive eating principles.

Internal Cues Messaging

Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.

External Cues Messaging

Eligibility Criteria

Age18 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIndividuals who identify as female are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • identify as female
  • college student

You may not qualify if:

  • outside of the age range of 18-29 years
  • do not self-identify as female
  • not able to attend an in-person study visit at the University of Delaware

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

Related Publications (1)

  • Pacanowski CR, Vizthum D, Cash H, Katcher JA, Skubisz C. A weight-centric health message elicits higher body shame in those at risk for eating disorders. Appl Psychol Health Well Being. 2025 Aug;17(4):e70061. doi: 10.1111/aphw.70061.

Study Officials

  • Carly R Pacanowski, PhD RD

    University of Delaware

    PRINCIPAL INVESTIGATOR
  • Christine Skubisz, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants are not aware of the condition they are assigned to.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants attend a single study visit and are randomized to view one of two nutrition education videos.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 10, 2022

First Posted

April 4, 2022

Study Start

January 20, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Dataset

Shared Documents
STUDY PROTOCOL, ICF

Locations