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

October 10, 2023 updated by: Carly R Pacanowski, University of Delaware

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19711
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1846581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Dataset

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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