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NCT06072664 Clinical Trial

Mother-Baby Study - Caloric Compensation Index (COMPX)

Eating Behavior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06072664
Other study ID # HUM00227836 CT3 (COMPX)
Secondary ID R01DK134979
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2023
Est. completion date January 2028

Study information
Verified date April 2024
Source University of Michigan
Contact Alex Jeanpierre
Phone 734-531-9869
Email ajeanp@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days and older
Eligibility The child is a participant in the observational study (NCT06039878).

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Caloric Compensation Index (COMPX)
Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
University of Michigan National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload Up to approximately 36 months
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