NCT01909635

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

Same day

First QC Date

July 24, 2013

Last Update Submit

March 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (2)

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.

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.

Behavioral: Other Feelings

Interventions

Food FeelingsBEHAVIORAL
Food Feelings
Other FeelingsBEHAVIORAL
Other Feelings

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory (HEAL)

Knoxville, Tennessee, 37996-1920, United States

Location

Related Links

MeSH Terms

Conditions

BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal

Study Officials

  • Hollie Raynor, Ph.D., R.D.

    University of Tennessee

    PRINCIPAL INVESTIGATOR
  • Kelsey Wallour, B.S.F.C.S.

    University of Tennessee

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Hollie Raynor, Ph.D., R.D.

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations