- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376439
Discordance of Obesity in Adolescent Sibilngs
October 1, 2020 updated by: Leonard Epstein, State University of New York at Buffalo
Non-shared Environments and Discordance of Obesity in Adolescent Sibilngs
This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).
Study Overview
Detailed Description
This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).
To accomplish this, siblings attend four laboratory sessions where they consume one of two types of kool-aid, smell the pizza, or rest quietly.
Siblings then eat a dinner meal.
Siblings also wear an activity monitor for one week and record their physical activity and sedentary activities in a habit book.
Study Type
Observational
Enrollment (Actual)
176
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
-
-
New York
-
Buffalo, New York, United States, 14214
- University at Buffalo
-
-
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
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Forty-eight sibling pairs (24 pairs of boys and 24 pairs of girls, 96 total adolescents) age 13 to 17 years who are discordant for overweight/obesity will be studied to assess potentially modifiable non-shared experiences within and outside the family environment that alter energy balance behaviors and contribute to adolescent overweight.
We will also measure the height and weight of up to 3 of their best friends.
Description
Inclusion Criteria:
- between 13-17 years old
- Have discordant same gender sibling (one is below 70th percentile, one is above 85th percentile
- Speak/read English
- Moderate or greater liking of study foods
Exclusion Criteria:
- No current diagnosis of a psychiatric or eating disorder.
- No dieting, dietary restrictions, or allergies that would interfere with study participation.
- No medications or conditions that could influence taste or appetite.
- No health concern or physical disability that would limit participation in physical activity.
- No endocrine or central nervous system disorder that could produce overweight.
- No current use of tobacco or nicotine products by the adolescent siblings.
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Siblings
Siblings will consume four test meals after 4 different exposures, including two types of koolaid, a control and a smell condition.
|
Participant drank two different types of kool-aid (sugar free and regular)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internal and external satiety calories consumed
Time Frame: Calories consumed are measured at week 1, week 2, week 3 and week 4.
|
Calories consumed during ad libitum meals are measured after consumption of a high energy dense preload and a low energy dense preload and also after an external cue (smell) and a control condition.
|
Calories consumed are measured at week 1, week 2, week 3 and week 4.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leonard Epstein, Ph.D., University at Buffalo
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
April 1, 2010
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 18, 2014
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
October 1, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1087494-1-54072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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