Feeding BehaviorsNCT02942589
Effect of Portion-control Training on Food Intake
A study testing Meal portion size in people with Feeding Behaviors, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 66 years, women only
- Conditions the study is for
- Feeding Behaviors
- What is being tested?
- Meal portion size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2015
- 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 20 to 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in the Portion-Control Strategies Trial (NCT01474759) OR
- Community control who regularly eats three meals per day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
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).
- Conditions
- Feeding Behaviors
- Being tested
- Meal portion size
- Keywords
- Portion Size
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal portion sizeOther
| Study group | Role | What they receive |
|---|---|---|
| 100% Portions | Experimental | Meal portion size: 100% Receives: Other: Meal portion size |
| 125% Portions | Experimental | Meal portion size: 125% Receives: Other: Meal portion size |
| 150% Portions | Experimental | Meal portion size: 150% Receives: Other: Meal portion size |
| 175% Portions | Experimental | Meal portion size: 175% Receives: Other: Meal portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in energy intake across subject groups
Calculated energy intake (kcal) based on weight and energy density of food consumed
Measured: Weeks 1, 2, 3, and 4
Difference in intake by weight across subject groups
Weights (grams) of all food consumed
Measured: Weeks 1, 2, 3, and 4
Difference in energy density consumed across subject groups
Energy density (kcal/gram) of all food consumed
Measured: Weeks 1, 2, 3, and 4
Secondary outcomes (1)
Ratings of hunger and satiety across subject groups
100-point visual analog scales
Measured: Weeks 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding BehaviorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942589
- Sponsor's protocol ID
- PortionSize103
- Other IDs
- R01DK059853
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Portion-control Training on Food Intake
- ClinicalTrials.gov ID
- NCT02942589
- Acronym / sponsor ID
- PortionSize103
- Conditions
- Feeding Behaviors
- Keywords
- Portion Size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Oct 2016 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100% Portions | Experimental | Other: Meal portion sizeMeal portion size: 100% |
| 125% Portions | Experimental | Other: Meal portion sizeMeal portion size: 125% |
| 150% Portions | Experimental | Other: Meal portion sizeMeal portion size: 150% |
| 175% Portions | Experimental | Other: Meal portion sizeMeal portion size: 175% |
Who may qualify
- Ages
- 20 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant in the Portion-Control Strategies Trial (NCT01474759) OR
- Community control who regularly eats three meals per day
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Meal portion size | Other | 100% Portions, 125% Portions, 150% Portions, 175% Portions |
Primary outcome
Difference in energy intake across subject groups
Time frame: Weeks 1, 2, 3, and 4
Calculated energy intake (kcal) based on weight and energy density of food consumed
Difference in intake by weight across subject groups
Time frame: Weeks 1, 2, 3, and 4
Weights (grams) of all food consumed
Difference in energy density consumed across subject groups
Time frame: Weeks 1, 2, 3, and 4
Energy density (kcal/gram) of all food consumed
1 secondary outcome
Ratings of hunger and satiety across subject groups
Time frame: Weeks 1, 2, 3, and 4
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 24 Oct 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal portion size in people with Feeding Behaviors, run by Penn State 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 24 Oct 2016. 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?
Difference in energy intake across subject groups (time frame: Weeks 1, 2, 3, and 4). The study lists 3 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 24 Oct 2016.