NCT01905293

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
Last Updated

July 23, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

July 11, 2013

Last Update Submit

July 18, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total energy intake

    Up to 3 weeks

Secondary Outcomes (4)

  • Energy intake from food

    Up to 3 weeks

  • Energy intake from beverage

    Up to 3 weeks

  • Percent estimated energy requirement (%EER)

    Up to 3 weeks

  • Relative reinforcing value of food (RRVF)

    Up to 3 weeks

Study Arms (3)

100% portion size

EXPERIMENTAL

100% portion size condition

Other: Feeding Study

150% portion size

EXPERIMENTAL

150% portion size condition

Other: Feeding Study

200% portion size

EXPERIMENTAL

200% portion size condition

Other: Feeding Study

Interventions

100% portion size150% portion size200% portion size

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 10 years of age
  • normal-weight or obese
  • like most foods that were served in the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tanja VE Kral, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 23, 2013

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Last Updated

July 23, 2013

Record last verified: 2013-06

Locations