Assessment of Thoughts and Feelings Occurring During and After a Meal

March 26, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville
Kelsey Wallour and Dr. Hollie Raynor are doing a study to investigate the effect of focusing on certain thoughts and feelings during a meal on liking of items in the meal. A total of 36 women are anticipated to participate in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During the orientation, informed consent will be obtained, questionnaires about your thoughts and feelings will be completed, and height and weight will be measured to calculate BMI. Next, for the remaining eligible participants, both meal sessions will be scheduled within a two-week period, with the sessions scheduled within one hour of being at the same time of day. These sessions will be scheduled at dinnertime, between four pm and seven pm, with each session lasting approximately 75 minutes. Before leaving the orientation session, you will be instructed to not exercise on either of the days of the sessions. You will also be instructed to not eat four hours before either of your sessions, but to eat in a similar manner earlier in the day for each session.

You will be randomized to one of two groups in which you will be asked to think about different things during your meal.

Group 1: If you are randomized to this group, you will be asked to think about your feelings of hunger, fullness, and the sensory qualities of the food (such as texture, smell, flavor) as you eat your meal.

Group 2: If you are randomized to this group, you will be asked to think about how hot or cold you feel, and how tired you are feeling as you eat your meal.

At the start of each meal session, you will complete a food recall to record what you have consumed that day prior to the scheduled session. Also, a seven-day physical activity recall will be collected prior to beginning the meal. If you have not followed directions regarding eating and exercise, the session will be rescheduled.

Next you will rate your hunger, fullness, and liking of each food in the meal on a scale. Then you will be instructed to consume a bowl of chocolate pudding within five minutes. When you have completed the pudding, there will be a 30-minute rest period in which you will be allowed to read or study. After the rest period and before the meal begins, you will again rate on the scale your hunger, fullness, and liking of each food in the meal. Then you will be asked to silence or turn off any electronic devices, after which the researcher will facilitate a brief raisin eating exercise. After the raisin eating exercise, the researcher will bring in your meal. The meal will last for 30 minutes and will be videotaped, and you will eat until pleasantly full. At the end of the thirty minutes, the researcher will come in and remove the food and you will rate your feelings of hunger, fullness, and liking of the foods in the meal, and then you will be done with the session.

At the second session, the procedure will be exactly the same. In addition, you will complete several questionnaires about your thoughts and feelings after completion of the meal.

Please call Dr. Hollie Raynor at (865) 974-6259 if you have any questions about these procedures for the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Tennessee
      • Knoxville, Tennessee, United States, 37996-1920
        • Healthy Eating and Activity Laboratory (HEAL)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females aged 18-35 years old
  • BMI greater than or equal to 25 kg/m2
  • Unrestrained eater
  • Do not have unfavorable preference or allergy to foods used in the investigation
  • Do not have a health condition or use medication that affects eating or requires a therapeutic diet
  • Must agree to instructions to not eat or exercise in stated hours before the sessions
  • Must agree to come into HEAL for an orientation session, and two sessions where, each time, the participant will consume a preload followed by a thirty-minute ad libitum meal

Exclusion Criteria:

  • Are pregnant or breastfeeding
  • Are actively dieting to lose weight
  • Report binge eating
  • Do not meet one or more of the above mentioned eligibility requirements

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Food Feelings
If you are randomized to this group, you will be asked to think about your feelings of hunger, fullness, and the sensory qualities of the food (such as texture, smell, flavor) as you eat your meal.
Behavioral: Food Feelings
Experimental: Other Feelings
If you are randomized to this group, you will be asked to think about how hot or cold you feel, and how tired you are feeling as you eat your meal.
Behavioral: Other Feelings

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total grams of ad libitum meal consumed
Time Frame: 1 year
The foods that will be used in this investigation are Tyson Chicken Breast Tenders, Ore-Ida Tater Tots, Birds Eye Steamfresh Pure & Simple green beans, and fresh oranges. Participants will be provided with ad libitum amounts of the foods, and the foods will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the meal. The weight of the container will also be measured. Total grams of each food consumed during the session will be determined by subtracting pre- and post-consumption weight of food.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hollie Raynor, Ph.D., R.D., University of Tennessee
  • Principal Investigator: Kelsey Wallour, B.S.F.C.S., University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9230 B

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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