Mother-Baby Study - Eating in the Absence of Hunger (EAH)

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06072638

Collaborator

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

120

Enrollment

Location

Arm

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behavior	Behavioral: Eating in Absence of Hunger	N/A

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 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eating in the Absence of Hunger (single arm) The researchers will enroll 120 children from the long-term observational study, NCT06039878.	Behavioral: Eating in Absence of Hunger Researcher gives child free access to palatable foods following a satiating meal.

Arm

Intervention/Treatment

Experimental: Eating in the Absence of Hunger (single arm)

The researchers will enroll 120 children from the long-term observational study, NCT06039878.

Behavioral: Eating in Absence of Hunger

Researcher gives child free access to palatable foods following a satiating meal.

Outcome Measures

Primary Outcome Measures

Kilocalories consumed [Up to approximately 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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

Investigators

Study Chair: Julie Lumeng, MD, 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, University of Michigan

ClinicalTrials.gov Identifier:

NCT06072638

Other Study ID Numbers:

HUM00227836 CT1
R01DK134979

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Julie Lumeng, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, University of Michigan

eating behavior

Study Results

No Results Posted as of Oct 10, 2023