The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
1 other identifier
interventional
300
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2022
CompletedOctober 11, 2023
October 1, 2023
11 months
February 10, 2022
October 10, 2023
Conditions
Keywords
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
EXPERIMENTALParticipants will view a five-minute video focusing on intuitive eating principles.
External Cues Messaging
ACTIVE COMPARATORParticipants will view a five-minute video focusing on traditional nutrition education principles.
Interventions
Participants will view a 5 minute nutrition education video focused on intuitive eating principles.
Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.
Eligibility Criteria
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
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.
PMID: 40781768DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Carly R Pacanowski, PhD RD
University of Delaware
- PRINCIPAL INVESTIGATOR
Christine Skubisz, PhD
University of Delaware
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
- 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
- Shared Documents
- STUDY PROTOCOL, ICF
Dataset