Behavior and Behavior MechanismsNCT01909635
Assessment of Thoughts and Feelings Occurring During and After a Meal
A study testing Food Feelings and Other Feelings in people with Behavior and Behavior Mechanisms and Food Habits, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms, Food Habits, Feeding Behavior
- What is being tested?
- Food Feelings and Other Feelings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2014
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory (HEAL)
Knoxville, Tennessee, 37996-1920
About this study
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.
Read the 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.
- Being tested
- Food Feelings, Other Feelings
- Medical subject headings
- Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food FeelingsBehavioural
Other FeelingsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Food Feelings | Experimental | 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. Receives: Behavioral: Food Feelings |
| Other Feelings | Experimental | 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. Receives: Behavioral: Other Feelings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total grams of ad libitum meal consumed
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2014 (estimated)
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Decision was made not to start the study before it was initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, Ph.D., R.D., Principal investigator, University of TennesseeKelsey Wallour, B.S.F.C.S., Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909635
- Sponsor's protocol ID
- 9230 B
- Status last verified
- Mar 2018
- First submitted
- 24 Jul 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thoughts and Feelings Occurring During and After a Meal
- ClinicalTrials.gov ID
- NCT01909635
- Acronym / sponsor ID
- 9230 B
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision was made not to start the study before it was initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jul 2014 (estimated)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Feelings | Experimental | Behavioral: Food FeelingsIf 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. |
| Other Feelings | Experimental | Behavioral: Other FeelingsIf 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Food Feelings | Behavioural | Food Feelings |
| Other Feelings | Behavioural | Other Feelings |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Healthy and Activity Lab InformationLink provided by the sponsor.
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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.
Hollie Raynor, Ph.D., R.D. principal investigator
University of Tennessee
Kelsey Wallour, B.S.F.C.S. principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Feelings and Other Feelings in people with Behavior and Behavior Mechanisms and Food Habits, run by The University of Tennessee, Knoxville 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 7 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: withdrawn, as of the sponsor's last update on 29 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Total grams of ad libitum meal consumed (time frame: 1 year). 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 29 Mar 2018.