Mother-Baby Study - Caloric Compensation Index (COMPX) | NCT06072664

Studies
Mother-Baby Study - Caloric Compensation Index (COMPX)

NCT06072664

Sponsor

University of Michigan

Status

Recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Eating Behavior

Interventions

Caloric Compensation Index (COMPX)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK134979	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2023Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Oct 2, 2023

First Submission Date that Met QC Criteria

Oct 2, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2025

Last Update Posted Date

Oct 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julie Lumeng, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caloric Compensation	Experimental	The researchers will enroll 150 children from the long-term observational study, NCT06039878.	Behavioral: Caloric Compensation Index (COMPX)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caloric Compensation Index (COMPX)	Behavioral	Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack	Caloric Compensation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The child is a participant in the observational study (NCT06039878).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alex Jeanpierre	Contact	734-531-9869		ajeanp@umich.edu

Overall Officials

Name	Affiliation	Role
Julie Lumeng, MD	University of Michigan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan	Recruiting	Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided