ObesityNCT01905293
Individual Differences in Children's Susceptibility to Overeating
A study testing Feeding Study in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The portion size of foods has been identified as an important determinant of energy intake in children. It remains to be determined to what extent child weight status and the relative reinforcing value of food may interact with the obesogenic food environment to affect energy intake. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Feeding Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2012
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8 to 10 years of age
- normal-weight or obese
- like most foods that were served in the study
Who cannot join
- serious medical conditions or medication use known to affect appetite, food intake, and body weight
- developmental or psychiatric conditions
- learning disability
- sight or hearing impairment
- food allergies or nutrient intolerances (including lactose intolerance)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The portion size of foods has been identified as an important determinant of energy intake in children. It remains to be determined to what extent child weight status and the relative reinforcing value of food may interact with the obesogenic food environment to affect energy intake. The primary aim of this study was to compare energy intake at a meal in normal-weight and obese children when the portion size of palatable, energy-dense foods and a sugar-sweetened beverage was systematically increased. We hypothesized that increasing the portion size of all foods and the beverage at a meal will lead to a significant increase in energy intake in both normal-weight and obese children. Obese children, however, will show a significantly greater increase in energy intake than will normal-weight children. A second aim of this study was to test if children's response to increases in portion size was affected by how reinforcing they find food to be. We hypothesized that, when controlling for BMI, children who find food very reinforcing relative to nonfood alternatives will show a significantly greater increase in energy intake than will children who find food less reinforcing.
Read the detailed description
The prevalence of childhood and adolescent obesity has reached an all-time high. There is a pressing need to better understand the behavioral mechanisms that control appetite and eating in children and to identify children who are most susceptible to overeating in the current obesogenic food environment. Obesogenic environments offer convenient access to large portions of palatable, energy-dense foods. The portion size of foods has been identified as an important determinant of energy intake in adults and children. While portion size effects have been found in heterogenous groups of healthy individuals, some evidence points to possible individual differences in the magnitude of children's responsiveness to large food portions. For example, data from a previous laboratory study suggest that overweight and obese children may be particularly vulnerable to overeating when presented with large food portions. Further, the magnitude of a portion size effect on intake may also depend on how reinforcing (or rewarding) children find food to be. It is possible that the relative reinforcing value of food may interact with environmental cues, such as the portion size of food, to affect children's energy intake when large portions of palatable, energy-dense foods are available. The primary aim of this study is to compare the effects of increasing the portion size of all foods and a beverage served at a meal on energy intake in normal-weight and obese children. A second aim is to test if children who find food very reinforcing relative to an appealing nonfood alternative will show a significantly greater increase in energy intake in response to increasing portion sizes than will children who find food less reinforcing. The findings from this study are expected to extend previous findings to test how environmental factors, such as food portion size, may interact with individual differences in weight status or food reinforcement to affect energy intake in children.
- Conditions
- Obesity
- Being tested
- Feeding Study
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding StudyOther
| Study group | Role | What they receive |
|---|---|---|
| 100% portion size | Experimental | 100% portion size condition Receives: Other: Feeding Study |
| 150% portion size | Experimental | 150% portion size condition Receives: Other: Feeding Study |
| 200% portion size | Experimental | 200% portion size condition Receives: Other: Feeding Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake
Measured: Up to 3 weeks
Secondary outcomes (4)
Energy intake from food
Measured: Up to 3 weeks
Energy intake from beverage
Measured: Up to 3 weeks
Percent estimated energy requirement (%EER)
Measured: Up to 3 weeks
Relative reinforcing value of food (RRVF)
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja VE Kral, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905293
- Sponsor's protocol ID
- R03DK091492
- Status last verified
- Jun 2013
- First submitted
- 11 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Children's Susceptibility to Overeating
- ClinicalTrials.gov ID
- NCT01905293
- Acronym / sponsor ID
- R03DK091492
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- First posted
- 23 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.
The portion size of foods has been identified as an important determinant of energy intake in children. It remains to be determined to what extent child weight status and the relative reinforcing value of food may interact with the obesogenic food environment to affect energy intake. The primary aim of this study was to compare energy intake at a meal in normal-weight and obese children when the portion size of palatable, energy-dense foods and a sugar-sweetened beverage was systematically increased. We hypothesized that increasing the portion size of all foods and the beverage at a meal will lead to a significant increase in energy intake in both normal-weight and obese children. Obese children, however, will show a significantly greater increase in energy intake than will normal-weight children. A second aim of this study was to test if children's response to increases in portion size was affected by how reinforcing they find food to be. We hypothesized that, when controlling for BMI, children who find food very reinforcing relative to nonfood alternatives will show a significantly greater increase in energy intake than will children who find food less reinforcing.
Detailed description
The prevalence of childhood and adolescent obesity has reached an all-time high. There is a pressing need to better understand the behavioral mechanisms that control appetite and eating in children and to identify children who are most susceptible to overeating in the current obesogenic food environment. Obesogenic environments offer convenient access to large portions of palatable, energy-dense foods. The portion size of foods has been identified as an important determinant of energy intake in adults and children. While portion size effects have been found in heterogenous groups of healthy individuals, some evidence points to possible individual differences in the magnitude of children's responsiveness to large food portions. For example, data from a previous laboratory study suggest that overweight and obese children may be particularly vulnerable to overeating when presented with large food portions. Further, the magnitude of a portion size effect on intake may also depend on how reinforcing (or rewarding) children find food to be. It is possible that the relative reinforcing value of food may interact with environmental cues, such as the portion size of food, to affect children's energy intake when large portions of palatable, energy-dense foods are available. The primary aim of this study is to compare the effects of increasing the portion size of all foods and a beverage served at a meal on energy intake in normal-weight and obese children. A second aim is to test if children who find food very reinforcing relative to an appealing nonfood alternative will show a significantly greater increase in energy intake in response to increasing portion sizes than will children who find food less reinforcing. The findings from this study are expected to extend previous findings to test how environmental factors, such as food portion size, may interact with individual differences in weight status or food reinforcement to affect energy intake in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100% portion size | Experimental | Other: Feeding Study100% portion size condition |
| 150% portion size | Experimental | Other: Feeding Study150% portion size condition |
| 200% portion size | Experimental | Other: Feeding Study200% portion size condition |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8 to 10 years of age
- normal-weight or obese
- like most foods that were served in the study
Key exclusion criteria (5 listed)
- serious medical conditions or medication use known to affect appetite, food intake, and body weight
- developmental or psychiatric conditions
- learning disability
- sight or hearing impairment
- food allergies or nutrient intolerances (including lactose intolerance)
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 |
|---|---|---|
| Feeding Study | Other | 100% portion size, 150% portion size, 200% portion size |
Primary outcome
Total energy intake
Time frame: Up to 3 weeks
4 secondary outcomes
Energy intake from food
Time frame: Up to 3 weeks
Energy intake from beverage
Time frame: Up to 3 weeks
Percent estimated energy requirement (%EER)
Time frame: Up to 3 weeks
Relative reinforcing value of food (RRVF)
Time frame: Up to 3 weeks
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 23 Jul 2013.
- National Institute of Diabetes and Digestive and Kidney DiseasesLink 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.
Tanja VE Kral, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding Study in people with Obesity, run by University of Pennsylvania 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 3 inclusion and 5 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 23 Jul 2013. 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?
Total energy intake (time frame: Up to 3 weeks). 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 23 Jul 2013.