NCT04114123

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,166

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

4.6 years

First QC Date

October 1, 2019

Last Update Submit

November 22, 2024

Conditions

Keywords

Reward-driven EatingInfantMaternal

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Julie Lumeng

    University of Michigan

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations