Eating Behaviors Among Weight-Discordant Siblings

May 10, 2012 updated by: Tanja Kral, University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study used a discordant sibling design to compare putative obesity-promoting eating traits among siblings, 5-12 years, who were raised in the same household, but were discordant for weight status (normal-weight: BMI-for-age between 5 and less than the 85th percentile; overweight/obese: BMI-for-age greater or equal to the 85th percentile). Forty-seven pairs of same-sex siblings (boys and girls) were recruited from the greater Philadelphia area to participate in a 4-week study during which their eating behaviors and body composition were assessed. The study tested the hypotheses that overweight/obese, compared to normal-weight, siblings exhibit 1) a weaker ability to compensate for calories, 2) a greater susceptibility towards eating in the absence of hunger, and 3) habitual dietary intakes that favor increased dietary energy density (kcal/g) and increased %energy derived from fat and caloric beverages. The use of a behavioral genetics design to study eating phenotypes among siblings is a unique approach to elucidate shared and non-shared environmental influences that can contribute to variations in weight status during childhood.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • same-sex;
  • weight discordant (normal-weight vs. overweight/obese);
  • meet age criteria;
  • like most foods that were served in the study.

Exclusion Criteria:

  • 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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low energy-dense preload
Other: Feeding study
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.
Experimental: High energy-dense preload
Other: Feeding study
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.
Experimental: No preload
Other: Feeding study
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Energy intake
Time Frame: Up to 4 weeks
%COMPX, EAH, dietary intake variables
Up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Single assessment at Week 4
Weight status (BMI-for-age percentile), BMI z-score, total body fat (%), waist circumference (cm), skinfold thickness (mm)
Single assessment at Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanja V.E. Kral, Ph.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K01DK078601 (U.S. NIH Grant/Contract)

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