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NCT06039878Active, not recruiting

Mother-Baby Study - Observational

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
250 (actual)
First submitted
10 Sept 2023
Start date
21 Dec 2023
Primary completion date
Feb 2029
Lead sponsor
University of Michigan
Diseases
Obesity
NCT number
NCT06039878

What you commit to

  • Study type: Interventional
  • Participants enrolled: 250
  • From 21 Dec 2023 to the primary completion date, Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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)

Age in the registry: 0 days to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.