- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942589
Effect of Portion-control Training on Food Intake
October 20, 2016 updated by: Barbara J. Rolls, Penn State University
The purpose of this study is to test whether food intake in response to large portion sizes differs between women who have received portion-control training and women who have not received such training.
In a crossover design, women come to the laboratory on four occasions to eat a lunch of seven foods varying in energy density.
Across meals, all foods are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts).
Food and energy intake is determined for each meal.
Participants are from two groups: women who completed a one-year weight-loss trial in which they were trained in portion-control strategies, and women who had not received such training (community controls).
Study Overview
Study Type
Interventional
Enrollment (Actual)
105
Phase
- 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
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Laboratory for the Study of Human Ingestive Behavior
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-
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
Ages Eligible for Study
20 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Participant in the Portion-Control Strategies Trial (NCT01474759) OR
- Community control who regularly eats three meals per day
Exclusion Criteria:
- Score on the Eating Attitudes Test indicating symptoms of disordered eating
- Score on the Zung or Beck questionnaires indicating symptoms of depression
- Food allergies or restrictions
- Dislike for foods served in the study
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 100% Portions
Meal portion size: 100%
|
|
|
Experimental: 125% Portions
Meal portion size: 125%
|
|
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Experimental: 150% Portions
Meal portion size: 150%
|
|
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Experimental: 175% Portions
Meal portion size: 175%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in energy intake across subject groups
Time Frame: Weeks 1, 2, 3, and 4
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Calculated energy intake (kcal) based on weight and energy density of food consumed
|
Weeks 1, 2, 3, and 4
|
|
Difference in intake by weight across subject groups
Time Frame: Weeks 1, 2, 3, and 4
|
Weights (grams) of all food consumed
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Weeks 1, 2, 3, and 4
|
|
Difference in energy density consumed across subject groups
Time Frame: Weeks 1, 2, 3, and 4
|
Energy density (kcal/gram) of all food consumed
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Weeks 1, 2, 3, and 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratings of hunger and satiety across subject groups
Time Frame: Weeks 1, 2, 3, and 4
|
100-point visual analog scales
|
Weeks 1, 2, 3, and 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratings of food taste across subject groups
Time Frame: Week 5
|
100-point visual analog scales
|
Week 5
|
|
Ratings of food healthfulness across subject groups
Time Frame: Week 5
|
100-point visual analog scales
|
Week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
October 19, 2016
First Submitted That Met QC Criteria
October 20, 2016
First Posted (Estimate)
October 24, 2016
Study Record Updates
Last Update Posted (Estimate)
October 24, 2016
Last Update Submitted That Met QC Criteria
October 20, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PortionSize103
- R01DK059853 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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