The Development of Reward Response to Food in Infancy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Behavior

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).

• Study Type: Observational
• Enrollment (Actual): 1166

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Longitudinal; The researchers will be evaluating baseline indicators of wanting salience and liking between 2 and 6 month olds, with the goal of following up with these families at 24 months and beyond by reviewing the dyads' medical charts. The researchers will also examine direct and indirect associations between reward-driven eating, and maternal and infant characteristics and infant weight-for-length.
Cross-sectional; The researchers will as the mother to answer questionnaires and participate in up to two video taped behavioral protocols when the infant is 6 months old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of trajectory membership and body mass index z-score (BMIz)	Trajectory membership could be "wanting", "salience", or "liking"	Time Frame: 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Association of reward-driven eating component wanting with maternal and infant characteristics	2 months through 24 months
Association of reward-driven eating component salience with maternal and infant characteristics	2 months through 24 months
Association of reward-driven eating component liking with maternal and infant characteristics	2 months through 24 months
Association of maternal and infant characteristics and weight-for-length z-score (WLZ)	2 months through 24 months
Association of infant reward-driven eating and weight-for-length z-score (WLZ)	2 months through 24 months
Association of infant reward-driven eating and infant diet	6 months through 24 months
Association of infant reward-driven eating and infant weight-for-length z-score (WLZ)	6 months through 24 months
Association of infant diet and infant weight-for-length z-score (WLZ)	6 months through 24 months

Other Outcome Measures

Outcome Measure	Time Frame
Association of maternal and infant characteristics and weight-for-length z-score (WLZ)	2 months through 24 months
Association of infant reward-driven eating and weight-for-length z-score (WLZ)	2 months through 24 months
Association of infant reward-driven eating and infant weight-for-length z-score (WLZ)	6 months through 24 months
Association of infant diet and infant weight-for-length z-score (WLZ)	6 months through 24 months
Association of reward-driven eating component wanting with maternal and infant characteristics	Up to 18 months
Association of reward-driven eating component salience with maternal and infant characteristics	Up to 18 months
Association of reward-driven eating component liking with maternal and infant characteristics	Up to 18 months
Association of infant reward-driven eating and infant diet	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Julie Lumeng, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Infant; Maternal; Reward-driven Eating
• Other Study ID Numbers: HUM00164906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research will generate demographic, anthropometric, dietary, behavioral questionnaire, and coded behavioral data. (Note the researchers will not make video data available.) The data will be stored as Statistical Package for the Social Sciences (SPSS) or Statistical Analysis System (SAS) files. Meta data will also be included in the selected repositories.The meta data will include the data dictionaries, which describe the generation of all variables, as well as the protocol manuals describing the behavioral protocols used to generate the variables.
• IPD Sharing Time Frame: Data submitted to Deep Blue Data will be reviewed after 10 years to determine if a dataset should be retained and will be subject to further, periodic, reviews thereafter.
• IPD Sharing Access Criteria: All data in the Deep Blue Data repository are available to anyone for download without restriction.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No