The Development of Reward Response to Food in Infancy

Eating Behavior Clinical Trial

Official title:

The Development of Reward Response to Food in Infancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04114123
• Other study ID #: HUM00164906
• Status: Active, not recruiting
• Start date: November 13, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1166
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of reward-driven eating component wanting with maternal and infant characteristics		Up to 18 months
Other	Association of reward-driven eating component salience with maternal and infant characteristics		Up to 18 months
Other	Association of reward-driven eating component liking with maternal and infant characteristics		Up to 18 months
Other	Association of maternal and infant characteristics and weight-for-length z-score (WLZ)		2 months through 24 months
Other	Association of infant reward-driven eating and weight-for-length z-score (WLZ)		2 months through 24 months
Other	Association of infant reward-driven eating and infant diet		Up to 18 months
Other	Association of infant reward-driven eating and infant weight-for-length z-score (WLZ)		6 months through 24 months
Other	Association of infant diet and infant weight-for-length z-score (WLZ)		6 months through 24 months
Primary	Association of trajectory membership and body mass index z-score (BMIz)	Trajectory membership could be "wanting", "salience", or "liking"	Time Frame: 24 months