NCT01598389

Brief Summary

The purpose of this study was to compare weight-discordant siblings in eating in the absence of hunger, caloric compensation, and the quality of their habitual diet. The investigator hypothesized that, within families and controlling for age differences, overweight and obese siblings would show greater eating in the absence of hunger, poorer caloric compensation, and poorer diet quality (e.g., increased percent of energy from fat and caloric beverages) compared to normal-weight siblings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2008

Typical duration 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

October 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.6 years

First QC Date

May 8, 2012

Last Update Submit

May 10, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    %COMPX, EAH, dietary intake variables

    Up to 4 weeks

Secondary Outcomes (1)

  • Body composition

    Single assessment at Week 4

Study Arms (3)

Low energy-dense preload

EXPERIMENTAL
Other: Feeding study

High energy-dense preload

EXPERIMENTAL
Other: Feeding study

No preload

EXPERIMENTAL
Other: Feeding study

Interventions

In a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls.

High energy-dense preloadLow energy-dense preloadNo preload

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • same-sex;
  • weight discordant (normal-weight vs. overweight/obese);
  • meet age criteria;
  • 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;
  • 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 Publications (1)

  • Kral TV, Allison DB, Birch LL, Stallings VA, Moore RH, Faith MS. Caloric compensation and eating in the absence of hunger in 5- to 12-y-old weight-discordant siblings. Am J Clin Nutr. 2012 Sep;96(3):574-83. doi: 10.3945/ajcn.112.037952. Epub 2012 Aug 1.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tanja V.E. 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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations