Observing mother-baby interactions related to obesity risk

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

This study looks at how mothers and babies interact during the first year of life to see how these relationships and feeding habits might affect the baby's risk of becoming overweight.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 0 Days and up
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT06039878 on ClinicalTrials.gov

What this trial studies

This observational study investigates the mechanisms behind emotional development, attachment, and feeding behaviors in infants during their first year of life, focusing on how these factors relate to obesity risk. It aims to categorize infant responses to various interventions, including bonding-evoked oxytocin and distress-relieving effects of sucrose, to better understand their eating behaviors and dietary intake. The study also examines the influence of maternal feeding practices on child adiposity and overall health outcomes. By linking these observations to maternal behaviors, the research seeks to identify patterns that could inform future interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are mother-infant dyads where the infant is between 37 to 42 weeks gestational age and meets specific weight criteria.

Not a fit: Patients who may not benefit from this study include those whose infants are born preterm or have significant health issues affecting feeding.

Why it matters

Potential benefit: If successful, this study could provide insights into early interventions that may reduce the risk of obesity in children.

How similar studies have performed: Other studies have shown success in understanding the relationship between early feeding behaviors and obesity risk, making this approach promising.

Eligibility criteria

To be eligible to participate in this study, they mother-child dyad must meet all of the following criteria:

1. Provision of signed and dated informed consent form by mother for herself and infant
2. Stated willingness by mother to comply with all study procedures and availability for the duration of the study
3. Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and child's birth date
4. Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set.
5. Mother is biological mother both genetically and gestationally by maternal report (i.e., conception with her own (versus donor) egg and she was pregnant (versus a surrogate)
6. Biological mother is legal guardian by maternal report
7. Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time)
8. Infant has fed at least 2.0 ounces in one feeding from an artificial nipple and bottle by maternal report or mother reports planning to do prior to first task requiring artificial nipple and bottle during age 1.0 month data collection window

Any dyad who meets any of the following criteria will be excluded from participation in this study:

1. Limited English proficiency in the mother; this is necessary because the questionnaires have only been validated in English-speaking populations.
2. Participation in another study involving treatment or intervention focused on mother or child emotion or attachment, child eating behavior, child dietary intake, or child growth
3. Mother \< 18.0 years old at time of consent prior to infant's first data collection window
4. Significant medical problems in the child or known diagnosis as reported by the mother that has significant potential to affect current or future eating, growth or development in the child as evaluated by PI Lumeng (e.g., cystic fibrosis, cleft palate, trisomy 13).
5. Significant medical problems in the mother as reported by the mother and assessed for significance by PI Lumeng (i.e., cancer, lupus)
6. Mother or infant taking medications likely to have significant effect on biological measures in study (e.g., steroids)
7. Family lives more than 1.5 hour driving distance from the University of Michigan. This is necessary to ensure study feasibility.
8. Family plans to move outside 1.5 hour driving distance from the University of Michigan before end of age 36-month data collection window. This is necessary to ensure study feasibility.
9. Child is product of multiple gestation (i.e., twins, triplets)
10. Significant complications for mother or infant during the pregnancy as assessed by PI Lumeng (e.g., eclampsia, preterm premature rupture of membranes)
11. Significant complications for mother or infant during the perinatal period as assessed by PI Lumeng (e.g., sepsis, hemorrhage requiring transfusion, persistent pulmonary hypertension of the newborn)

All participants must be enrolled in all parts of the Mother-Baby study (1 Observational study and 4 Clinical Trials)

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Alex Jeanpierre

Conditions Obesity, Childhood; Obesity; weight gain