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OpenTrials
Active, Not Recruiting

NCT Number: NCT06039878

Mother-Baby Study - Observational

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Provision of signed and dated informed consent form by mother for herself and infant
  • Stated willingness by mother to comply with all study procedures and availability for the duration of the study
  • Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and child's birth date
  • Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set.
  • 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)
  • Biological mother is legal guardian by maternal report
  • Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time)
  • 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:

  • Limited English proficiency in the mother; this is necessary because the questionnaires have only been validated in English-speaking populations.
  • 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
  • Mother < 18.0 years old at time of consent prior to infant's first data collection window
  • 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).
  • Significant medical problems in the mother as reported by the mother and assessed for significance by PI Lumeng (i.e., cancer, lupus)
  • Mother or infant taking medications likely to have significant effect on biological measures in study (e.g., steroids)
  • Family lives more than 1.5 hour driving distance from the University of Michigan. This is necessary to ensure study feasibility.
  • 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.
  • Child is product of multiple gestation (i.e., twins, triplets)
  • Significant complications for mother or infant during the pregnancy as assessed by PI Lumeng (e.g., eclampsia, preterm premature rupture of membranes)
  • 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)

Treatment and study plan

Bonding-Evoked Oxytocin

Behavioral

Mother participates in bonding activity with infant at ages 1, 3, and 6 months

Distress Relieving Effects of Sucrose

Behavioral

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

Hedonic Response to Sucrose

Behavioral

Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months

Typical versus Challenging Feeding-Social

Behavioral

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.

Caloric Compensation-Social

Behavioral

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.

Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)

Behavioral

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.

Primary outcomes

  1. Weight-for-length z-score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 15, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.