ObesityNCT02376439
Discordance of Obesity in Adolescent Sibilngs
An observational study of Obesity, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Kool-aid
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Obesity
- Being tested
- Kool-aid
- Keywords
- siblings, overweight, adolescent
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kool-aidOther
Participant drank two different types of kool-aid (sugar free and regular)
| Study group | Role | What they receive |
|---|---|---|
| Siblings | Siblings will consume four test meals after 4 different exposures, including two types of koolaid, a control and a smell condition. Receives: Other: Kool-aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal and external satiety calories consumed
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.
Measured: Calories consumed are measured at week 1, week 2, week 3 and week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard Epstein, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376439
- Sponsor's protocol ID
- 1087494-1-54072
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2014
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-shared Environments and Discordance of Obesity in Adolescent Sibilngs
- ClinicalTrials.gov ID
- NCT02376439
- Acronym / sponsor ID
- 1087494-1-54072
- Conditions
- Obesity
- Keywords
- siblings, overweight, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siblings | – | Other: Kool-aidSiblings will consume four test meals after 4 different exposures, including two types of koolaid, a control and a smell condition. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kool-aidParticipant drank two different types of kool-aid (sugar free and regular) | Other | Siblings |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Epstein, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal and external satiety calories consumed (time frame: Calories consumed are measured at week 1, week 2, week 3 and week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.