Mother-Baby Study - Observational

Not Applicable

Recruiting

• Conditions: Obesity; Obesity, Childhood
• Interventions: Behavioral: Bonding-Evoked Oxytocin; Behavioral: Distress Relieving Effects of Sucrose; Behavioral: Hedonic Response to Sucrose; Behavioral: Typical versus Challenging Feeding-Social; Behavioral: Caloric Compensation-Social; Behavioral: Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)

• Registration Number: NCT06039878
• Lead Sponsor: University of Michigan

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-15
• Study Start: 2023-12-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mother-Infant Dyad	Caloric Compensation-Social	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Mother-Infant Dyad	Hedonic Response to Sucrose	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Mother-Infant Dyad	Distress Relieving Effects of Sucrose	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Mother-Infant Dyad	Bonding-Evoked Oxytocin	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Mother-Infant Dyad	Typical versus Challenging Feeding-Social	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Mother-Infant Dyad	Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)	The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).

Primary Outcome Measures

Name	Time	Method
Weight-for-length z-score	Up to 36 months (infant age)	Infants will be weighed and length will be measured recumbent using an infantometer. Weight-for-length will be calculated and z-scored against World Health Organization growth charts

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States