Mother-Baby Study - Caloric Compensation Index (COMPX)

NCT ID: NCT06072664

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2028-01-31

Brief Summary

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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

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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.

Conditions

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Eating Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Caloric Compensation

The researchers will enroll 150 children from the long-term observational study, NCT06039878.

Group Type EXPERIMENTAL

Caloric Compensation Index (COMPX)

Intervention Type BEHAVIORAL

Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack

Interventions

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Caloric Compensation Index (COMPX)

Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

0 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Julie Lumeng

Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Lumeng, MD

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alex Jeanpierre

Role: CONTACT

734-531-9869

Facility Contacts

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Alex Jeanpierre

Role: primary

734-531-9869

Other Identifiers

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R01DK134979

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00227836 CT3 (COMPX)

Identifier Type: -

Identifier Source: org_study_id

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