Mother-Baby Study - Observational

Launched by UNIVERSITY OF MICHIGAN · Sep 10, 2023

Keywords

ClinConnect Summary

The Mother-Baby Study is looking at how weight gain in a baby’s first year might lead to obesity later in life. Researchers want to understand how emotions, attachment between mother and child, and how they eat together can affect a child’s growth and eating habits. This is an observational trial, meaning they will be watching and gathering information rather than providing treatments or interventions. The study is currently recruiting families with infants aged 0 to 12 months, and it welcomes participants of all genders.

To participate, mothers and their infants must meet certain criteria. For example, mothers need to be the biological and legal guardians of their child and must be available for study activities. The infant should be born within normal weight ranges and must have been fed from a bottle at least once. However, families who have certain medical issues or live too far from the study site in Michigan may not be eligible. Participants can expect to complete questionnaires and provide information about their feeding practices and the baby’s growth over time. This study aims to gather valuable insights that could help in understanding and preventing childhood obesity.

Gender

ALL

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)