Mother-Baby Study - Caloric Compensation Index (COMPX)

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: Recruiting
• Conditions: Eating Behavior
• Intervention / Treatment: Behavioral: Caloric Compensation Index (COMPX)

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

• Study Contact: Name: Alex Jeanpierre; Phone Number: 734-531-9869; Email: ajeanp@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Julie Lumeng, MD
      • Contact: Alex Jeanpierre; Phone Number: 734-531-9869; Email: ajeanp@umich.edu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caloric Compensation; The researchers will enroll 150 children from the long-term observational study, NCT06039878.	Behavioral: Caloric Compensation Index (COMPX); Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Chair: Julie Lumeng, MD, University of Michigan

Study record dates

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 (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: eating behavior
• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Feeding Behavior
• Other Study ID Numbers: HUM00227836 CT3 (COMPX); 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