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

Sponsor

University of Delaware (Other)

Overall Status

Recruiting

CT.gov ID

NCT05309941

Collaborator

(none)

300

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

90.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Dietetics Diet, Healthy Nutrition Therapy Affect Autonomic Nervous System	Other: Internal Cues Nutrition Messaging Other: External Cues Nutrition Messaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants attend a single study visit and are randomized to view one of two nutrition education videos.Participants attend a single study visit and are randomized to view one of two nutrition education videos.

Masking:

Single (Participant)

Masking Description:

The participants are not aware of the condition they are assigned to.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Internal Cues Messaging Participants will view a five-minute video focusing on intuitive eating principles.	Other: Internal Cues Nutrition Messaging Participants will view a 5 minute nutrition education video focused on intuitive eating principles.
Active Comparator: External Cues Messaging Participants will view a five-minute video focusing on traditional nutrition education principles.	Other: External Cues Nutrition Messaging Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.

Arm

Intervention/Treatment

Experimental: Internal Cues Messaging

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

Other: Internal Cues Nutrition Messaging

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

Active Comparator: External Cues Messaging

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

Other: External Cues Nutrition Messaging

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

Outcome Measures

Primary Outcome Measures

Change in Heart Rate Variability (HRV) [HRV will be measured during a 3-minute baseline period and while watching a 5-minute intervention video.]
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.
Change in Affect [The PANAS is administered before and immediately after viewing the video.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-29 years old
identify as female
student at University of Delaware

Exclusion Criteria:

outside of the age range of 18-29 years
do not self-identify as female
not a student at the University of Delaware

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Delaware	Newark	Delaware	United States	19711

Sponsors and Collaborators

University of Delaware

Investigators

Principal Investigator: Carly R Pacanowski, PhD RD, University of Delaware
Principal Investigator: Christine Skubisz, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carly R Pacanowski, Assistant Professor, University of Delaware

ClinicalTrials.gov Identifier:

NCT05309941

Other Study ID Numbers:

1846581

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carly R Pacanowski, Assistant Professor, University of Delaware

nutrition messaging

nutrition education

Intuitive Eating

Study Results

No Results Posted as of Apr 4, 2022