Appetitive BehaviorNCT04836416
Appetite Variability
An observational study of Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
This study will examine appetitive sensation variability and the relationship between appetitive sensations and energy intake. Investigators believe the methods for assessing and interpretation of appetitive sensations are problematic and mask the true influence of these sensations on eating. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Observational
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 31 Dec 2022
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- Age 18-65 years.
- Body weight fluctuation of <2.5 kg in the past 3 months.
Who cannot join
- Having an acute disease.
- Planning to initiate or terminate medication known to affect appetite.
- Planning to initiate or terminate lifestyle behaviors that could affect energy balance
- Age <18 or >65 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appetite Ratings and Eating Patterns
This study will examine appetitive sensation variability and the relationship between appetitive sensations and energy intake. Investigators believe the methods for assessing and interpretation of appetitive sensations are problematic and mask the true influence of these sensations on eating. This limits the development of guidelines for weight management. To gain a better understanding of the relationship, investigators will track hourly appetite sensations and map these to eating events via time-series analyses to gain new insights on the directionality and magnitude of these relationships. Also, investigators will also examine the association of apetitive ratings with age or gender. This will allow the development of more effective weight management recommendations.
Read the detailed description
Screening - The study will be advertised through various public media sources (social media, posted flyers, Purdue Today) and a verbal conversation. Participants responding to the advertisements will be scheduled for a screening visit. This meeting will begin with a full description of the study, and investigators will secure informed written consent. Participants will complete questionnaires eliciting demographic (age, biological sex, BMI, fat%), dietary (eating traits), and health (acute and chronic disease history) information. Height and weight will be measured. For those choosing to enroll, investigators will obtain baseline measurements to confirm eligibility. Individuals qualified and volunteering to participate in the trial will complete multiple questionnaires about eating habits ( Meal pattern questionnaire, Power of food scale, 0 Study Materials - Appetite Training Material.pdf 0 Study Materials - ASA24 instruction .pdf 0 Eating Trait questionnaires.pdf 0 Study Materials - Appetite Lexicon Quiz.docx 0 Hourly Appetite and Thirst Ratings.pdf 0 Study Timeline.pdf Emotional eating scale, Eating inventory, Food craving inventory, Adult eating behavior scales, Self-regulation of eating behavior questionnaire, Barrot Impulsiveness scale). Participants will also learn how to record their energy intake through the ASA-24 system. Then, participants will get training on the lexicon of appetite sensations with a video tutorial, followed by an online quiz to confirm their understanding of the concepts. At least 90% of correct responses are required to pass the appetite lexicon training. Failure to satisfactorily convey an understanding of the concepts will result in an offer to repeat the training two more times or be rejected from the study. Study Procedure - Enrolled participants will have a virtual meeting with a researcher (E. Cheon) once a week through Zoom to remind participants about the necessity and method for recording of appetite/thirst ratings, dietary recalls, and physical activity to be completed during three days (2 non-consecutive weekdays and
1 weekend day). Participants will be asked to report to the laboratory for instruction on recording appetitive sensations (hunger, fullness, thirst), food intake, physical activity at baseline (week1), week 9, and 17 on 3 days (2 non-consecutive weekdays and 1 weekend day). Ratings of hunger, fullness, and thirst will be recorded on their cell phones/computers via a web-based Qualtrics survey every waking hour for 3 days. All entries are time and date stamped to ensure the ratings are made at the intended times. Participants will be provided hourly alarms to ensure regular recording.
Concurrently, participants will keep a diet record with an ASA-24 system and free-living energy expenditure will be measured using a physical activity tracking application on the same days of appetite ratings.
- Conditions
- Appetitive Behavior
- Being tested
- Observational
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Young Adult/Normal | Age 18-35, BMI 18.5-24.9 Receives: Other: Observational | |
| Young Adult/Overweight and Obese | Age18-35, BMI greater than 25.0 Receives: Other: Observational | |
| Adult/Normal | Age 36-50, BMI 18.5-24.9 Receives: Other: Observational | |
| Adult/Overweight and Obese | Age 36-50, BMI greater than 25.0 Receives: Other: Observational | |
| Older Adult/Nornal | Age 51-65, BMI 18.5-24.9 Receives: Other: Observational | |
| Older Adult/Overweight and Obese | Age 51-65, BMI greater than 25.0 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger
A positive association between hunger and eating frequency.
Measured: 4 months
Thirst
A positive association between thirst and energy intake from beverages.
Measured: 4 Months
Fullness
A positive association between fullness and portion size.
Measured: 4 Months
Energy Intake
A positive association between combined hunger (determinant of eating frequency) and fullness (determinant of portion size) ratings and energy intake.
Measured: 4 Months
Age
A negative association between appetitive sensation intensities and age.
Measured: 4 Months
Gender
No significant association between appetitive sensation intensities and gender.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Apr 2021
- Primary completion2 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836416
- Sponsor's protocol ID
- 2020-1651
- Status last verified
- May 2024
- First submitted
- 5 Apr 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Ratings and Eating Patterns
- ClinicalTrials.gov ID
- NCT04836416
- Acronym / sponsor ID
- 2020-1651
- Conditions
- Appetitive Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Apr 2021 (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 study will examine appetitive sensation variability and the relationship between appetitive sensations and energy intake. Investigators believe the methods for assessing and interpretation of appetitive sensations are problematic and mask the true influence of these sensations on eating. This limits the development of guidelines for weight management. To gain a better understanding of the relationship, investigators will track hourly appetite sensations and map these to eating events via time-series analyses to gain new insights on the directionality and magnitude of these relationships. Also, investigators will also examine the association of apetitive ratings with age or gender. This will allow the development of more effective weight management recommendations.
Detailed description
Screening - The study will be advertised through various public media sources (social media, posted flyers, Purdue Today) and a verbal conversation. Participants responding to the advertisements will be scheduled for a screening visit. This meeting will begin with a full description of the study, and investigators will secure informed written consent. Participants will complete questionnaires eliciting demographic (age, biological sex, BMI, fat%), dietary (eating traits), and health (acute and chronic disease history) information. Height and weight will be measured. For those choosing to enroll, investigators will obtain baseline measurements to confirm eligibility. Individuals qualified and volunteering to participate in the trial will complete multiple questionnaires about eating habits ( Meal pattern questionnaire, Power of food scale, 0 Study Materials - Appetite Training Material.pdf 0 Study Materials - ASA24 instruction .pdf 0 Eating Trait questionnaires.pdf 0 Study Materials - Appetite Lexicon Quiz.docx 0 Hourly Appetite and Thirst Ratings.pdf 0 Study Timeline.pdf Emotional eating scale, Eating inventory, Food craving inventory, Adult eating behavior scales, Self-regulation of eating behavior questionnaire, Barrot Impulsiveness scale). Participants will also learn how to record their energy intake through the ASA-24 system. Then, participants will get training on the lexicon of appetite sensations with a video tutorial, followed by an online quiz to confirm their understanding of the concepts. At least 90% of correct responses are required to pass the appetite lexicon training. Failure to satisfactorily convey an understanding of the concepts will result in an offer to repeat the training two more times or be rejected from the study. Study Procedure - Enrolled participants will have a virtual meeting with a researcher (E. Cheon) once a week through Zoom to remind participants about the necessity and method for recording of appetite/thirst ratings, dietary recalls, and physical activity to be completed during three days (2 non-consecutive weekdays and
1 weekend day). Participants will be asked to report to the laboratory for instruction on recording appetitive sensations (hunger, fullness, thirst), food intake, physical activity at baseline (week1), week 9, and 17 on 3 days (2 non-consecutive weekdays and 1 weekend day). Ratings of hunger, fullness, and thirst will be recorded on their cell phones/computers via a web-based Qualtrics survey every waking hour for 3 days. All entries are time and date stamped to ensure the ratings are made at the intended times. Participants will be provided hourly alarms to ensure regular recording.
Concurrently, participants will keep a diet record with an ASA-24 system and free-living energy expenditure will be measured using a physical activity tracking application on the same days of appetite ratings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Young Adult/Normal | – | Other: ObservationalAge 18-35, BMI 18.5-24.9 |
| Young Adult/Overweight and Obese | – | Other: ObservationalAge18-35, BMI greater than 25.0 |
| Adult/Normal | – | Other: ObservationalAge 36-50, BMI 18.5-24.9 |
| Adult/Overweight and Obese | – | Other: ObservationalAge 36-50, BMI greater than 25.0 |
| Older Adult/Nornal | – | Other: ObservationalAge 51-65, BMI 18.5-24.9 |
| Older Adult/Overweight and Obese | – | Other: ObservationalAge 51-65, BMI greater than 25.0 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- Age 18-65 years.
- Body weight fluctuation of <2.5 kg in the past 3 months.
Key exclusion criteria (4 listed)
- Having an acute disease.
- Planning to initiate or terminate medication known to affect appetite.
- Planning to initiate or terminate lifestyle behaviors that could affect energy balance
- Age <18 or >65 years.
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 |
|---|---|---|
| ObservationalObservational | Other | Adult/Normal, Adult/Overweight and Obese, Older Adult/Nornal, Older Adult/Overweight and Obese, Young Adult/Normal, Young Adult/Overweight and Obese |
Primary outcome
Hunger
Time frame: 4 months
A positive association between hunger and eating frequency.
Thirst
Time frame: 4 Months
A positive association between thirst and energy intake from beverages.
Fullness
Time frame: 4 Months
A positive association between fullness and portion size.
Energy Intake
Time frame: 4 Months
A positive association between combined hunger (determinant of eating frequency) and fullness (determinant of portion size) ratings and energy intake.
Age
Time frame: 4 Months
A negative association between appetitive sensation intensities and age.
Gender
Time frame: 4 Months
No significant association between appetitive sensation intensities and gender.
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 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Appetitive Behavior
Recruiting
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Appetitive Behavior, Obesity
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
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.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetitive Behavior, run by Purdue University 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 2 inclusion and 4 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 7 May 2024. 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?
Hunger (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.