The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect

Diet, Healthy Clinical Trial

Official title:

The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309941
• Other study ID #: 1846581
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• 18-29 years old
• identify as female
• college student

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Affect
• Autonomic Nervous System
• Diet, Healthy
• Nutrition Therapy

Intervention

Other:
• Internal Cues Nutrition Messaging
Participants will view a 5 minute nutrition education video focused on intuitive eating principles.
• External Cues Nutrition Messaging
Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.