- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598389
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
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
Interventional
Enrollment (Actual)
94
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Low energy-dense preload
|
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
|
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
|
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
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
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
Investigators
- 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.
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
October 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
May 8, 2012
First Submitted That Met QC Criteria
May 10, 2012
First Posted (Estimate)
May 15, 2012
Study Record Updates
Last Update Posted (Estimate)
May 15, 2012
Last Update Submitted That Met QC Criteria
May 10, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- K01DK078601 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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