Early Genetic and Environmental Influences on Eating - The Baylor Infant Twins Study

NCT04306523 | Completed

• 1 other identifier: H-36097
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Body Composition; Executive Functioning; Temperament

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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

  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.

  24 months

• Laboratory Temperament Assessment Battery (Lab-Tab)

  Lab-Tab is an assessment of infant temperament using laboratory observations

  4 months

• Laboratory Temperament Assessment Battery (Lab-Tab)

  Lab-Tab is an assessment of infant temperament using laboratory observations

  6 months

• Laboratory Temperament Assessment Battery (Lab-Tab)

  Lab-Tab is an assessment of infant temperament using laboratory observations

  12 months

Secondary Outcomes (11)

• Body composition

  4 months

• Body composition

  6 months

• Body composition

  12 months

• Height

  4 months

• Height

  6 months

Study Arms (1)

Observational Cohort

One group of 100 sets of twin infants, observed from 4 months of age until 2years of age.

Other: Observation

Interventions

Observation OTHER

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.

Observational Cohort

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Twin infants

You may qualify if:

• 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

You may not qualify if:

• Singleton infant
• Gestational less than 34 weeks
• Birthweight less than 1800 grams
• Diagnosis of twin to twin transfusion syndrome, or intrauterine growth retardation

Sponsors & Collaborators

• Baylor College of Medicine: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

infant: urine sample, fecal sample, fingernails, buccal /saliva sample maternal: buccal sample, saliva sample, fecal sample

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Alexis C Wood, PhD

  Children's Nutrition Research Center, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: March 13, 2020
• Study Start: October 1, 2015
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)