Body CompositionBITSNCT04306523
Early Genetic and Environmental Influences on Eating - The Baylor Infant Twins Study
An observational study of Body Composition and Executive Functioning, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to better understand the genetic and environmental etiology of early infant effortful control and infant feeding behaviors, and preschool executive functioning and eating behaviors. Read more about this study
- Who is it for?
- Ages 4 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Executive Functioning, Temperament
- What is being tested?
- Observation
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2024
- 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 4 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Twin infants
Who may be able to join
- Infants from a multiple pregnancy (twins only)
- Born at > 34 weeks gestation,
- Not less than 1800 grams birth weight
- No diagnosis of twin to twin transfusion syndrome, or intrauterine growth retardation
Who cannot join
- Singleton infant
- Gestational less than 34 weeks
- Birthweight less than 1800 grams
- Diagnosis of twin to twin transfusion syndrome, or intrauterine growth retardation
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: Early Genetic and Environmental Influences on Eating: The Baylor Infant Twin Study (BITS)
The purpose of this study is to better understand the genetic and environmental etiology of early infant effortful control and infant feeding behaviors, and preschool executive functioning and eating behaviors. An additional purpose is to establish whether these four constructs (infant effortful control; infant feeding behaviors; preschool executive functioning; and preschool eating behaviors) have shared genetic and / or environment etiologies.
Study objectives:
(1) Evaluate the extent to which genetic influences on infants' effortful control of behavior are modified by prenatal diet, exercise and stress (2) Estimate the extent to which infant effortful control of behavior predicts and shares genetic influences with preschool executive functioning, and preschool eating behaviors. (3) Identify which genes are associated with infant effortful control behavior, preschool executive functioning, and preschool eating behaviors. (4) Examine whether there is a pattern of bacteria in the gut microbiome which associates with infant effortful control of behavior, preschool executive functioning, and preschool eating behaviors.
Read the detailed description
The Baylor Infant Twin Study will conduct data collection at four time points. Three visits will occur at the Children's Nutrition Research Center (CNRC) Metabolic Research Unit at 4 months, 6 months and 12 months. At 4 and 6 months of age, a home visit will also be conducted. At 24 months of age, study related questionnaires will be sent by postal mail to be completed and returned to research study staff.
Details of each visit:
4 months: Mother and twin infants will be admitted to the Children's Nutrition Research Center (CNRC) Metabolic Research Unit (MRU) at four months corrected gestational age, written consent will be obtained. At the initial visit, procedures for each infant and mother will be completed. For each infant, the procedures to be completed at 4 months will be (1) an observation of the infant's feeding; for this procedure, while the mother is feeding a infant his/her formula or breast milk(bottle or by breast), a video camera will be recording the session. If needed, research staff will coordinate timing so that the infants are fed so that one follows the other. On the other hand, if the infants are usually fed together (tandem feeding of twin infants), the feeding bottles (or nursing at breast) will be given to each infant at the same time and mother will feed twin infants together during the feeding episode as she normally would do. (2) During the feeding episode, for infants who are being bottle fed, the mother will be asked to use an ordinary infant feeding bottle with an added special pressure sensor while infant sucks their regular feed from it. The device is a regular baby bottle that has a special pressure sensing chamber that measures the infant's sucking patterns, strength and consistency. The mother may decline using the bottle with sensors, or if tried with the infant but the infant refuses, the feeding will be resumed with the bottle brought by the mother. (3) Body composition of the infant will be measured using Dual-Energy X-Ray Absorptiometry (DXA) using a Hologic Delphi-A densitometer. These procedures provide estimates of total body bone, fat, and lean mass. (4) Observations of infant's behavior will be observed and recorded for 20 minutes in these situations: being shown a black and white checkerboard, listening to a ringing bell, listening and viewing a shaken ball/rattle, and being presented a ball/rattle, that is later taken away, a puppet game, peek-a-boo game, playing in a jungle gym, and infant viewing pictures on a computer screen. (5) The physical activity of the infant will be measured for about 1.5 hours by using three ActiGraph GT3X+ accelerometers (Pensacola, FL, USA), placed on each leg of the infant (below knee and above the ankle), another device on the infant's waist. (6) A microbiome sample from the infant will be obtained by study staff collecting fecal sample from diaper for the pattern of bacteria in infant's gut. (7) A urine sample will be obtained for epigenetic (methylation) analysis and will be collected by using a special bag that will be placed over the infant's genital area. (8) Finger nail samples will be obtained by gentle clipping for epigenetic (methylation) analysis. (9) A saliva sample for genetic DNA analysis will be collected. To collect the saliva sample, a staff member will gently rub a stick with a cotton end (similar to a Q-tip) against the infant's cheek for about 30 seconds.
The mother will be asked to complete questionnaires for each infant: Infant Behavior Questionnaire - Very Short Version, Milestones Questionnaire, Infant Feeding History Questionnaire, and Infant Eating Behavior Questionnaire. The mother will be asked to complete procedures at the initial visit. First, a maternal microbiome sample; the mother will be instructed how to collect her fecal sample in the MRU or at her home. Second, a maternal buccal cell sample will be collected from the mother by gently rubbing a stick with a cotton end (similar to a Q-tip) against mother's cheek for about 30 seconds. The mother will be asked to collect her own saliva in a container provided to her.
Home visit: Within a week a home visit will be scheduled to assess infants' behavior. The same process conducted in the laboratory will be conducted at home where infant's behavior will be observed and recorded for 20 minutes in these situations: being shown a black and white checkerboard, listening to a ringing bell, listening and viewing a shaken ball/rattle, and being presented a ball/rattle, that is later taken away, a puppet game, peek-a-boo game, playing in a jungle gym, and baby viewing pictures on a computer screen.
6 months: Behavior observation, physical activity and body composition measurement outlined above will be conducted. The mother will complete Infant Behavior Questionnaire - Very Short Version, Milestones Questionnaire, Infant Feeding History Questionnaire, and Infant Eating Behavior Questionnaire.
Home visit: Within a week a home visit will be scheduled to assess infants' behavior as outlined above.
12 months: Behavior observation, physical activity, body composition measurement outlined above will be conducted. Additionally, a feeding observation to asses food neophobia in twins will be conducted. The mother will be asked to offer a new food (Quinoa or Couscous) to the infant. Infant's response to the new food will be video recorded for 3 minutes. The mother will complete Infant Behavior Questionnaire - Very Short Version and Child Eating Behavior Questionnaire (CEBQ).
24 month: Mother will be sent (via mail) four Questionnaires for each child: Strength and Difficulty Questionnaire (SDQ), Milestone Questionnaire, Eating Behavior (Children's Eating Behavior Questionnaire (CEBQ)), Height And Weight Questionnaire. All questionnaires will be mailed and when completed the mother will return to research staff in a self-addressed envelope.
- Conditions
- Body Composition, Executive Functioning, Temperament
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
4 months: observation of infant feeding behavior, behavior/temperament; bio-specimen collection; body composition, sucking intensity/frequency, activity intensity/frequency; maternal reports of feeding and behavior/temperament; maternal biospecimen. 6 month: behavior/temperament assessment, physical activity, and body composition. 12 month: Feeding behavior, behavior/temperament assessment, physical activity, and body composition. 24 month: maternal reports of children's eating behavior, behavior/temperament.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | One group of 100 sets of twin infants, observed from 4 months of age until 2years of age. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Behavior Questionnaire (IBQ)
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Measured: 4 months
Infant Behavior Questionnaire (IBQ)
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Measured: 6 months
Infant Behavior Questionnaire (IBQ)
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Measured: 12 months
Rejection of novel food
Observer coded food neophobia will be assessed by video recording infant's reaction to a novel food. The coding will be based on the scale developed by, and utilized in, MOding, Birch and Stifter, 2014, Appetite
Measured: 12 months
Child Eating Behavior Questionnaire (CEBQ)
CEBQ is a parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. It is made up of eight eating behavior sub-scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness. A higher mean score for each specific sub-scale suggest the child shows a higher tendency toward the respective eating behavior. For example a higher mean score on food responsiveness suggests the child is food responsive.
Measured: 24 months
Laboratory Temperament Assessment Battery (Lab-Tab)
Lab-Tab is an assessment of infant temperament using laboratory observations
Measured: 4 months
Laboratory Temperament Assessment Battery (Lab-Tab)
Lab-Tab is an assessment of infant temperament using laboratory observations
Measured: 6 months
Laboratory Temperament Assessment Battery (Lab-Tab)
Lab-Tab is an assessment of infant temperament using laboratory observations
Measured: 12 months
Secondary outcomes (11)
Body composition
Percentage body fat using DXA scan
Measured: 4 months
Body composition
Percentage body fat using DXA scan
Measured: 6 months
Body composition
Percentage body fat using DXA scan
Measured: 12 months
Height
Child's recumbent length in centimeters will be measured
Measured: 4 months
Height
Child's recumbent length in centimeters will be measured
Measured: 6 months
Height
Child's recumbent length in centimeters will be measured
Measured: 12 months
Weight
Child's weight in kilograms will be measured using digital scale
Measured: 4 months
Weight
Child's weight in kilograms will be measured using digital scale
Measured: 6 months
Weight
Child's weight in kilograms will be measured using digital scale
Measured: 12 months
Microbiome analysis of fecal samples from infant, child, and mother
The bacterial pattern of the infant, child's, and maternal samples of stool will be assayed.
Measured: 4 months
Genetic and Epigenetic analyses of selected genes
The presence of selected genes related to effortful control, executive functioning, and eating behavior will be assayed from saliva and buccal samples; The epigenetic (methylation) status of selected genes will be compared in urine and fingernail samples of infants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startOct 2015
- Primary completionJul 2024
- Study completionJul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Alexis Wood, Baylor College of Medicine
- Investigators
- Alexis C Wood, PhD, Principal investigator, Children's Nutrition Research Center, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306523
- Sponsor's protocol ID
- H-36097
- Acronym
- BITS
- Status last verified
- Jul 2024
- First submitted
- 30 Jan 2020
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data of individuals will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Genetic and Environmental Influences on Eating: The Baylor Infant Twin Study (BITS)
- ClinicalTrials.gov ID
- NCT04306523
- Acronym / sponsor ID
- BITS / H-36097
- Conditions
- Body Composition, Executive Functioning, Temperament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Oct 2015
- Primary completion
- Jul 2024 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 13 Mar 2020 (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.
The purpose of this study is to better understand the genetic and environmental etiology of early infant effortful control and infant feeding behaviors, and preschool executive functioning and eating behaviors. An additional purpose is to establish whether these four constructs (infant effortful control; infant feeding behaviors; preschool executive functioning; and preschool eating behaviors) have shared genetic and / or environment etiologies.
Study objectives:
(1) Evaluate the extent to which genetic influences on infants' effortful control of behavior are modified by prenatal diet, exercise and stress (2) Estimate the extent to which infant effortful control of behavior predicts and shares genetic influences with preschool executive functioning, and preschool eating behaviors. (3) Identify which genes are associated with infant effortful control behavior, preschool executive functioning, and preschool eating behaviors. (4) Examine whether there is a pattern of bacteria in the gut microbiome which associates with infant effortful control of behavior, preschool executive functioning, and preschool eating behaviors.
Detailed description
The Baylor Infant Twin Study will conduct data collection at four time points. Three visits will occur at the Children's Nutrition Research Center (CNRC) Metabolic Research Unit at 4 months, 6 months and 12 months. At 4 and 6 months of age, a home visit will also be conducted. At 24 months of age, study related questionnaires will be sent by postal mail to be completed and returned to research study staff.
Details of each visit:
4 months: Mother and twin infants will be admitted to the Children's Nutrition Research Center (CNRC) Metabolic Research Unit (MRU) at four months corrected gestational age, written consent will be obtained. At the initial visit, procedures for each infant and mother will be completed. For each infant, the procedures to be completed at 4 months will be (1) an observation of the infant's feeding; for this procedure, while the mother is feeding a infant his/her formula or breast milk(bottle or by breast), a video camera will be recording the session. If needed, research staff will coordinate timing so that the infants are fed so that one follows the other. On the other hand, if the infants are usually fed together (tandem feeding of twin infants), the feeding bottles (or nursing at breast) will be given to each infant at the same time and mother will feed twin infants together during the feeding episode as she normally would do. (2) During the feeding episode, for infants who are being bottle fed, the mother will be asked to use an ordinary infant feeding bottle with an added special pressure sensor while infant sucks their regular feed from it. The device is a regular baby bottle that has a special pressure sensing chamber that measures the infant's sucking patterns, strength and consistency. The mother may decline using the bottle with sensors, or if tried with the infant but the infant refuses, the feeding will be resumed with the bottle brought by the mother. (3) Body composition of the infant will be measured using Dual-Energy X-Ray Absorptiometry (DXA) using a Hologic Delphi-A densitometer. These procedures provide estimates of total body bone, fat, and lean mass. (4) Observations of infant's behavior will be observed and recorded for 20 minutes in these situations: being shown a black and white checkerboard, listening to a ringing bell, listening and viewing a shaken ball/rattle, and being presented a ball/rattle, that is later taken away, a puppet game, peek-a-boo game, playing in a jungle gym, and infant viewing pictures on a computer screen. (5) The physical activity of the infant will be measured for about 1.5 hours by using three ActiGraph GT3X+ accelerometers (Pensacola, FL, USA), placed on each leg of the infant (below knee and above the ankle), another device on the infant's waist. (6) A microbiome sample from the infant will be obtained by study staff collecting fecal sample from diaper for the pattern of bacteria in infant's gut. (7) A urine sample will be obtained for epigenetic (methylation) analysis and will be collected by using a special bag that will be placed over the infant's genital area. (8) Finger nail samples will be obtained by gentle clipping for epigenetic (methylation) analysis. (9) A saliva sample for genetic DNA analysis will be collected. To collect the saliva sample, a staff member will gently rub a stick with a cotton end (similar to a Q-tip) against the infant's cheek for about 30 seconds.
The mother will be asked to complete questionnaires for each infant: Infant Behavior Questionnaire - Very Short Version, Milestones Questionnaire, Infant Feeding History Questionnaire, and Infant Eating Behavior Questionnaire. The mother will be asked to complete procedures at the initial visit. First, a maternal microbiome sample; the mother will be instructed how to collect her fecal sample in the MRU or at her home. Second, a maternal buccal cell sample will be collected from the mother by gently rubbing a stick with a cotton end (similar to a Q-tip) against mother's cheek for about 30 seconds. The mother will be asked to collect her own saliva in a container provided to her.
Home visit: Within a week a home visit will be scheduled to assess infants' behavior. The same process conducted in the laboratory will be conducted at home where infant's behavior will be observed and recorded for 20 minutes in these situations: being shown a black and white checkerboard, listening to a ringing bell, listening and viewing a shaken ball/rattle, and being presented a ball/rattle, that is later taken away, a puppet game, peek-a-boo game, playing in a jungle gym, and baby viewing pictures on a computer screen.
6 months: Behavior observation, physical activity and body composition measurement outlined above will be conducted. The mother will complete Infant Behavior Questionnaire - Very Short Version, Milestones Questionnaire, Infant Feeding History Questionnaire, and Infant Eating Behavior Questionnaire.
Home visit: Within a week a home visit will be scheduled to assess infants' behavior as outlined above.
12 months: Behavior observation, physical activity, body composition measurement outlined above will be conducted. Additionally, a feeding observation to asses food neophobia in twins will be conducted. The mother will be asked to offer a new food (Quinoa or Couscous) to the infant. Infant's response to the new food will be video recorded for 3 minutes. The mother will complete Infant Behavior Questionnaire - Very Short Version and Child Eating Behavior Questionnaire (CEBQ).
24 month: Mother will be sent (via mail) four Questionnaires for each child: Strength and Difficulty Questionnaire (SDQ), Milestone Questionnaire, Eating Behavior (Children's Eating Behavior Questionnaire (CEBQ)), Height And Weight Questionnaire. All questionnaires will be mailed and when completed the mother will return to research staff in a self-addressed envelope.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Other: ObservationOne group of 100 sets of twin infants, observed from 4 months of age until 2years of age. |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Twin infants
Key inclusion criteria (4 listed)
- Infants from a multiple pregnancy (twins only)
- Born at > 34 weeks gestation,
- Not less than 1800 grams birth weight
- No diagnosis of twin to twin transfusion syndrome, or intrauterine growth retardation
Key exclusion criteria (4 listed)
- Singleton infant
- Gestational less than 34 weeks
- Birthweight less than 1800 grams
- Diagnosis of twin to twin transfusion syndrome, or intrauterine growth retardation
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 |
|---|---|---|
| Observation4 months: observation of infant feeding behavior, behavior/temperament; bio-specimen collection; body composition, sucking intensity/frequency, activity intensity/frequency; maternal reports of feeding and behavior/temperament; maternal biospecimen. 6 month: behavior/temperament assessment, physical activity, and body composition. 12 month: Feeding behavior, behavior/temperament assessment, physical activity, and body composition. 24 month: maternal reports of children's eating behavior, behavior/temperament. | Other | Observational Cohort |
Primary outcome
Infant Behavior Questionnaire (IBQ)
Time frame: 4 months
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Infant Behavior Questionnaire (IBQ)
Time frame: 6 months
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Infant Behavior Questionnaire (IBQ)
Time frame: 12 months
IBQ is a mother-reported Infant temperament scale comprised of 37 items that measure the frequency of range of specified infant behaviors over the last two weeks that assess three aspects of temperament 1. Positive affectivity/surgency (PAS), 2. Negative emotionality (NEG), and 3. Orienting and regulatory capacity (ORC) on a scale ranging from 1-7. A higher score indicates a higher frequency of behavior and a lower score indicates a lower frequency of the behavior.
Rejection of novel food
Time frame: 12 months
Observer coded food neophobia will be assessed by video recording infant's reaction to a novel food. The coding will be based on the scale developed by, and utilized in, MOding, Birch and Stifter, 2014, Appetite
Child Eating Behavior Questionnaire (CEBQ)
Time frame: 24 months
CEBQ is a parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. It is made up of eight eating behavior sub-scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness. A higher mean score for each specific sub-scale suggest the child shows a higher tendency toward the respective eating behavior. For example a higher mean score on food responsiveness suggests the child is food responsive.
Laboratory Temperament Assessment Battery (Lab-Tab)
Time frame: 4 months
Lab-Tab is an assessment of infant temperament using laboratory observations
Laboratory Temperament Assessment Battery (Lab-Tab)
Time frame: 6 months
Lab-Tab is an assessment of infant temperament using laboratory observations
Laboratory Temperament Assessment Battery (Lab-Tab)
Time frame: 12 months
Lab-Tab is an assessment of infant temperament using laboratory observations
11 secondary outcomes
Body composition
Time frame: 4 months
Body composition
Time frame: 6 months
Body composition
Time frame: 12 months
Height
Time frame: 4 months
Height
Time frame: 6 months
Height
Time frame: 12 months
Weight
Time frame: 4 months
Weight
Time frame: 6 months
Weight
Time frame: 12 months
Microbiome analysis of fecal samples from infant, child, and mother
Time frame: 4 months
Genetic and Epigenetic analyses of selected genes
Time frame: 12 months
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 29 Jul 2024.
- Individual participant dataSharing planned: No. No data of individuals will be shared
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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.
Alexis C Wood, PhD principal investigator
Children's Nutrition Research Center, Baylor College of Medicine
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 Body Composition and Executive Functioning, 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 4 inclusion and 4 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 29 Jul 2024. 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?
Infant Behavior Questionnaire (IBQ) (time frame: 4 months). The study lists 8 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 29 Jul 2024.