NCT06039878

Mother-Baby Study - Observational

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 0 Days
• Healthy volunteers: Accepted

Summary

The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

Detailed description

This multi-year study was originally accurately registered as an observational study. The outcome measures are not measuring dependent variables based on the interventions; rather the interventions are experiments to categorize infant responses for the purpose of grouping infants according to their behaviors. There are small trials associated with the grant at National Clinical Trial numbers (NCT #s): NCT06072664, NCT06072651, and NCT06072638 to analyze behaviors at 18 and 36 months of age. However, because the NIH grant covering this study needs to be linked to a trial for computer smart logic purposes, and this overarching study connects with the most complete enrollment numbers, the record was modified in 2024 to show it as a trial.

Conditions

• Obesity, Childhood
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Bonding-Evoked Oxytocin	Mother participates in bonding activity with infant at ages 1, 3, and 6 months
BEHAVIORAL	Distress Relieving Effects of Sucrose	Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition
BEHAVIORAL	Hedonic Response to Sucrose	Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months
BEHAVIORAL	Typical versus Challenging Feeding-Social	Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not.
BEHAVIORAL	Caloric Compensation-Social	Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not.
BEHAVIORAL	Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)	When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months.

Timeline

• Start date: 2023-12-21
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2023-09-15
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States