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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05309941
Other study ID # 1846581
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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