Clinical trial NCT06039878: Mother-Baby Study - Observational
Official title: Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Obesity
Keywords: weight gain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-15
Enrollment: 240
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Weight-for-length z-score
timeFrame: Up to 36 months (infant age)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Lumeng, MD
role: STUDY_CHAIR
References: