Clinical trial NCT04114123: The Development of Reward Response to Food in Infancy
Official title: The Development of Reward Response to Food in Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
Keywords: Reward-driven Eating
Infant
Maternal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-10-03
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The researchers will enroll infants and their mothers (age limit given is for minimum age for mothers) from the community and from sites allowed and approved by the IRB like pediatric clinics and childcare centers. They will be recruiting participants living within a 50 mile radius around Ann Arbor, MI.

Brief summary: In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 18 months. The researchers hope to use this knowledge to help inform obesity prevention programs.

Detailed description: The study will comprise two arms and each arm has a different time perspective. The longitudinal arm is prospective in nature and the cross-sectional arm has a cross-sectional time perspective. The video observation is completed at a single time point (although standardized by inclusion criteria).

Eligibility criteria: For the Longitudinal Arm:

Inclusion Criteria

* Baby is alive
* Baby is 6 to 16 weeks old at time of enrollment
* Baby and mother receive care at Michigan Medicine, and specifically:

  * Baby was born at Michigan medicine
  * Baby has had a 2 month well child check
  * Mother received prenatal care at Michigan Medicine
  * Mother has a linked patient profile to baby's profile
  * Baby has a length and weight measurement on record
* Mother is English speaking

Exclusion Criteria

* Baby is a foster child
* Baby was still in hospital 4 days after birth
* Baby has severe perinatal or neonatal medical problems
* Baby has severe developmental delays
* Multiple births

For the Cross Sectional:

Inclusion Criteria

* Enrolled in longitudinal arm of study
* Eligible to complete all three protocols (Two Oatmeal and Reaching) as per protocol screeners
* Baby is alive
* Baby is 5 to 7 months old at the time of enrollment
* Mother is biological mother
* Mother is legal guardian
* Mother is English speaking

Exclusion Criteria

* Baby had severe perinatal or neonatal medical problems
* Baby currently has severe medical problems
* Baby has severe developmental delays
* Mom had severe complications during pregnancy
* Multiple Births
* Food allergies

Primary outcomes:
measure: Association of trajectory membership and body mass index z-score (BMIz)
timeFrame: Time Frame: 24 months
Secondary outcomes:
Other outcomes:
measure: Association of reward-driven eating component wanting with maternal and infant characteristics
timeFrame: Up to 18 months
measure: Association of reward-driven eating component salience with maternal and infant characteristics
timeFrame: Up to 18 months
measure: Association of reward-driven eating component liking with maternal and infant characteristics
timeFrame: Up to 18 months
measure: Association of maternal and infant characteristics and weight-for-length z-score (WLZ)
timeFrame: 2 months through 24 months
measure: Association of infant reward-driven eating and weight-for-length z-score (WLZ)
timeFrame: 2 months through 24 months
measure: Association of infant reward-driven eating and infant diet
timeFrame: Up to 18 months
measure: Association of infant reward-driven eating and infant weight-for-length z-score (WLZ)
timeFrame: 6 months through 24 months
measure: Association of infant diet and infant weight-for-length z-score (WLZ)
timeFrame: 6 months through 24 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Lumeng
role: PRINCIPAL_INVESTIGATOR
References: