DieteticsNCT05309941
The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
A study testing Internal Cues Nutrition Messaging and External Cues Nutrition Messaging in people with Dietetics and Diet, Healthy, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietetics, Diet, Healthy, Nutrition Therapy
- What is being tested?
- Internal Cues Nutrition Messaging and External Cues Nutrition Messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 years old
- identify as female
- college student
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dietetics, Diet, Healthy, Nutrition Therapy, Affect, Autonomic Nervous System
- Being tested
- Internal Cues Nutrition Messaging, External Cues Nutrition Messaging
- Keywords
- nutrition messaging, nutrition education, Intuitive Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Cues Nutrition MessagingOther
Participants will view a 5 minute nutrition education video focused on intuitive eating principles.
External Cues Nutrition MessagingOther
Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.
| Study group | Role | What they receive |
|---|---|---|
| Internal Cues Messaging | Experimental | Participants will view a five-minute video focusing on intuitive eating principles. Receives: Other: Internal Cues Nutrition Messaging |
| External Cues Messaging | Active comparator | Participants will view a five-minute video focusing on traditional nutrition education principles. Receives: Other: External Cues Nutrition Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The PANAS is administered before and immediately after viewing the video.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start20 Jan 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DieteticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants attend a single study visit and are randomized to view one of two nutrition education videos.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly R Pacanowski, University of Delaware
- Investigators
- Carly R Pacanowski, PhD RD, Principal investigator, University of DelawareChristine Skubisz, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309941
- Sponsor's protocol ID
- 1846581
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset
Publications
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.
PubMed 40781768
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
- ClinicalTrials.gov ID
- NCT05309941
- Acronym / sponsor ID
- 1846581
- Conditions
- Dietetics, Diet, Healthy, Nutrition Therapy, Affect, Autonomic Nervous System
- Keywords
- nutrition messaging, nutrition education, Intuitive Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants attend a single study visit and are randomized to view one of two nutrition education videos.
| Arm | Type | Receives |
|---|---|---|
| Internal Cues Messaging | Experimental | Other: Internal Cues Nutrition MessagingParticipants will view a five-minute video focusing on intuitive eating principles. |
| External Cues Messaging | Active comparator | Other: External Cues Nutrition MessagingParticipants will view a five-minute video focusing on traditional nutrition education principles. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-29 years old
- identify as female
- college student
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Cues Nutrition MessagingParticipants will view a 5 minute nutrition education video focused on intuitive eating principles. | Other | Internal Cues Messaging |
| External Cues Nutrition MessagingParticipants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading. | Other | External Cues Messaging |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 40781768Pacanowski 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.
- Individual participant dataSharing planned: Yes. Dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly R Pacanowski, PhD RD principal investigator
University of Delaware
Christine Skubisz, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Cues Nutrition Messaging and External Cues Nutrition Messaging in people with Dietetics and Diet, Healthy, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.