- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072651
Mother-Baby Study - Relative Reinforcing Value (RRV)
September 3, 2026 updated by: Julie Lumeng, University of Michigan
Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.
To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months.
In the observational study there are 300 participants (150 mothers and 150 children).
In this trial only data from the children is collected and therefore only 150 participants are listed.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
The child is a participant in the observational study (NCT06039878).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Relative Reinforcing Value
The researchers will enroll 150 children from the long-term observational study, NCT06039878.
|
Researcher gives child opportunity to press a button to earn three types of rewards: a high-reward food, a low-reward food, and a non-food reward.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Reinforcing Value (RRV) of food
Time Frame: Up to approximately 36 months
|
The RRV is measured using the number of button presses for each reward type relative to other reward types
|
Up to approximately 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Julie Lumeng, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2023
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
October 2, 2023
First Submitted That Met QC Criteria
October 2, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00227836 CT2
- R01DK134979 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.