The Development of Reward Response to Food in Infancy

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04114123
• Collaborator: American Heart Association (Other)
• Enrollment: 2,500
• Location: 1
• Anticipated Duration (Months): 58.6
• Patients Per Site Per Month: 42.7

Study Details

Study Description

Brief Summary

In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 24 months. The researchers hope to use this knowledge to help inform obesity prevention programs.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: The Development of Reward Response to Food in Infancy
• Actual Study Start Date: Nov 13, 2019
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Association of trajectory membership and body mass index z-score (BMIz) [24 months]

   Trajectory membership could be "wanting", "salience", or "liking"

Secondary Outcome Measures

1. Association of reward-driven eating component wanting with maternal and infant characteristics [2 months through 24 months]

2. Association of reward-driven eating component salience with maternal and infant characteristics [2 months through 24 months]

3. Association of reward-driven eating component liking with maternal and infant characteristics [2 months through 24 months]

4. Association of maternal and infant characteristics and weight-for-length z-score (WLZ) [2 months through 24 months]

5. Association of infant reward-driven eating and weight-for-length z-score (WLZ) [2 months through 24 months]

6. Association of infant reward-driven eating and infant diet [6 months through 24 months]

7. Association of infant reward-driven eating and infant weight-for-length z-score (WLZ) [6 months through 24 months]

8. Association of infant diet and infant weight-for-length z-score (WLZ) [6 months through 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

For the Longitudinal Arm:

Inclusion Criteria

• Baby is alive

• Baby is 6 to 12 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

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

• Baby and mother continue to receive primary care at Michigan Medicine, specifically:

• Baby has had a recent well child check (4 month and / or 6 month)

• Mother has a linked patient profile to baby's profile

• Eligible to complete both 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• American Heart Association

Investigators

• Principal Investigator: Julie Lumeng, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julie Lumeng, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School, Professor of Nutritional Sciences, University of Michigan
• ClinicalTrials.gov Identifier: NCT04114123
• Other Study ID Numbers: HUM00164906
• First Posted: Oct 3, 2019
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julie Lumeng, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School, Professor of Nutritional Sciences, University of Michigan: Reward-driven Eating; Infant; Maternal

Study Results

No Results Posted as of Oct 11, 2021