ObesityNCT03116334
Genetic Influences Between Cognitive Function and BMI
An observational study of Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
In this study the investigators will interrogate an existing data set to examine whether genetic variants contribute to an inverse association between weight status and cognitive function. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 869 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2016
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Individuals from the Texas twin Project dataset, who were twins and higher-order multiples previously recruited from the Houston and Austin Metropolitan areas, via flyers, the internet (study website) and contact through public school rosters
Who may be able to join
- All participants in the TTP database with executive functioning and BMI data, without a parent-reported medical disorder affecting growth
Who cannot join
- Parent-reported medical disorder affecting growth More than one sibling in the dataset (if triplets are present, only two randomly selecting siblings will be included).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77030
About this study
Official title: Shared Genetic Influences Between Cognitive Function and Body Mass Index (BMI) in the Texas Twin Project
In this study the investigators will interrogate an existing data set to examine whether genetic variants contribute to an inverse association between weight status and cognitive function. Investigators hypothesize that body mass index (BMI) will be inversely related to a number of variables measuring cognitive function, and that that this inverse relation will be at least partially attributable to genetic variants which influence both BMI and cognition.
Read the detailed description
Investigators will use existing data collected as part of the Texas Twin Project (TTP). TTP collected neuropsychological task data on cognition (executive functioning and general cognitive abilities) from a computerized test battery, as well as BMI data, on a sample of 869 twins. Investigators will use information from the known extent of genetic and environmental sharing between members of MZ (monozygotic; identical) and DZ (dizygotic; fraternal) twin pairs to quantify the genetic correlation between measures of cognition and BMI using biometric genetic modeling under the assumptions of the classical twin model. The specific aims are:
- To examine the association between BMI and executive functioning (EF) in a sample of 869 twin children, ages 7 to 15 years old, who participated in the Texas Twin Project (TTP)
- To gauge the specificity of EF-BMI relations relative to academic achievement and general cognitive abilities.
- To examine the relative contribution of genetic and environment influences to the inverse association between BMI and EF
- Conditions
- Obesity
- Keywords
- Obesity, BMI, executive functioning, general cognitive ability, twin study, heritability, cognition, GCTA
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning
This measure will be derived from a computerized test battery incorporating the Animal Stroop, Stop Signal, Mickey (an anti- Trail Making, Local-Global, Plus-Minus, Digit Span Backward, Symmetry Span, Listening Recall, 2-Back, Keeping Track, and Running Memory for Letters tasks. A latent factor of variance common to all these tasks will be used to indicate "higher order executive functioning".
Measured: 2 hours
Body mass index
Heights and weights were measured by trained study personnel and BMI will be calculated as weight in kilograms (kg) divided by height in centimeters (cm) squared.
Measured: 10 minutes
Secondary outcomes (2)
General Cognitive Ability
This was assessed using the WASI-II
Measured: 1 hour
Academic Achievement
This was assessed using the Woodcock-Johnson-III Calculations and Passage Comprehension tests
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startSep 2009
- Primary completionDec 2016
- Study completionDec 2016
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 Baylor College of MedicineThe 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
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Wood, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116334
- Sponsor's protocol ID
- H-37801
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This protocol involves secondary data analysis of existing studies. Data will not be shared with other investigators since they should obtain data from the primary sources.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Genetic Influences Between Cognitive Function and Body Mass Index (BMI) in the Texas Twin Project
- ClinicalTrials.gov ID
- NCT03116334
- Acronym / sponsor ID
- H-37801
- Conditions
- Obesity
- Keywords
- Obesity, BMI, executive functioning, general cognitive ability, twin study, heritability, cognition, GCTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
In this study the investigators will interrogate an existing data set to examine whether genetic variants contribute to an inverse association between weight status and cognitive function. Investigators hypothesize that body mass index (BMI) will be inversely related to a number of variables measuring cognitive function, and that that this inverse relation will be at least partially attributable to genetic variants which influence both BMI and cognition.
Detailed description
Investigators will use existing data collected as part of the Texas Twin Project (TTP). TTP collected neuropsychological task data on cognition (executive functioning and general cognitive abilities) from a computerized test battery, as well as BMI data, on a sample of 869 twins. Investigators will use information from the known extent of genetic and environmental sharing between members of MZ (monozygotic; identical) and DZ (dizygotic; fraternal) twin pairs to quantify the genetic correlation between measures of cognition and BMI using biometric genetic modeling under the assumptions of the classical twin model. The specific aims are:
- To examine the association between BMI and executive functioning (EF) in a sample of 869 twin children, ages 7 to 15 years old, who participated in the Texas Twin Project (TTP)
- To gauge the specificity of EF-BMI relations relative to academic achievement and general cognitive abilities.
- To examine the relative contribution of genetic and environment influences to the inverse association between BMI and EF
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Individuals from the Texas twin Project dataset, who were twins and higher-order multiples previously recruited from the Houston and Austin Metropolitan areas, via flyers, the internet (study website) and contact through public school rosters
Key inclusion criteria (1 listed)
- All participants in the TTP database with executive functioning and BMI data, without a parent-reported medical disorder affecting growth
Key exclusion criteria (1 listed)
- Parent-reported medical disorder affecting growth More than one sibling in the dataset (if triplets are present, only two randomly selecting siblings will be included).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Executive functioning
Time frame: 2 hours
This measure will be derived from a computerized test battery incorporating the Animal Stroop, Stop Signal, Mickey (an anti- Trail Making, Local-Global, Plus-Minus, Digit Span Backward, Symmetry Span, Listening Recall, 2-Back, Keeping Track, and Running Memory for Letters tasks. A latent factor of variance common to all these tasks will be used to indicate "higher order executive functioning".
Body mass index
Time frame: 10 minutes
Heights and weights were measured by trained study personnel and BMI will be calculated as weight in kilograms (kg) divided by height in centimeters (cm) squared.
2 secondary outcomes
General Cognitive Ability
Time frame: 1 hour
Academic Achievement
Time frame: 30 minutes
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 18 Apr 2017.
- Individual participant dataSharing planned: No. This protocol involves secondary data analysis of existing studies. Data will not be shared with other investigators since they should obtain data from the primary sources.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Baylor College of Medicine 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 1 inclusion and 1 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 18 Apr 2017. 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?
Executive functioning (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 18 Apr 2017.