The Development of Reward Response to Food in Infancy
1 other identifier
observational
1,166
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedStudy Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2024
CompletedNovember 26, 2024
November 1, 2024
4.6 years
October 1, 2019
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association of trajectory membership and body mass index z-score (BMIz)
Trajectory membership could be "wanting", "salience", or "liking"
Time Frame: 24 months
Other Outcomes (8)
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
- +5 more other outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- Baby had severe perinatal or neonatal medical problems
- Baby currently has severe medical problems
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- American Heart Associationcollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Lumeng
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School, Professor of Nutritional Sciences
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 3, 2019
Study Start
November 13, 2019
Primary Completion
June 19, 2024
Study Completion
June 19, 2024
Last Updated
November 26, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- All data in the Deep Blue Data repository are available to anyone for download without restriction.
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.