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Mother-Baby Study - Observational

Mother-Baby Study - Observational

Recruiting
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Phase N/A

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Overview

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.

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

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 is the mother's first live birth (i.e., first born) by maternal report
  9. 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 age 1.0 month 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)

Study details
    Obesity
    Childhood
    Obesity

NCT06039878

University of Michigan

14 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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