Mother-Baby Study - Observational
- Conditions
- Obesity, ChildhoodObesity
- Registration Number
- NCT06039878
- Lead Sponsor
- University of Michigan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
To be eligible to participate in this study, they mother-child dyad must meet all of the<br>following criteria:<br><br> 1. Provision of signed and dated informed consent form by mother for herself and infant<br><br> 2. Stated willingness by mother to comply with all study procedures and availability<br> for the duration of the study<br><br> 3. Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and<br> child's birth date<br><br> 4. Infant birth weight by maternal report appropriate (= 3rd percentile and = 97th<br> percentile) for gestational age and sex based on US Natality Data set.<br><br> 5. Mother is biological mother both genetically and gestationally by maternal report<br> (i.e., conception with her own (versus donor) egg and she was pregnant (versus a<br> surrogate)<br><br> 6. Biological mother is legal guardian by maternal report<br><br> 7. Biological mother is full time custodial guardian by maternal report (versus sharing<br> custody such that infant does not live with her full time)<br><br> 8. Infant has fed at least 2.0 ounces in one feeding from an artificial nipple and<br> bottle by maternal report or mother reports planning to do prior to first task<br> requiring artificial nipple and bottle during age 1.0 month data collection window<br><br>Any dyad who meets any of the following criteria will be excluded from participation in<br>this study:<br><br> 1. Limited English proficiency in the mother; this is necessary because the<br> questionnaires have only been validated in English-speaking populations.<br><br> 2. Participation in another study involving treatment or intervention focused on mother<br> or child emotion or attachment, child eating behavior, child dietary intake, or<br> child growth<br><br> 3. Mother < 18.0 years old at time of consent prior to infant's first data collection<br> window<br><br> 4. Significant medical problems in the child or known diagnosis as reported by the<br> mother that has significant potential to affect current or future eating, growth or<br> development in the child as evaluated by PI Lumeng (e.g., cystic fibrosis, cleft<br> palate, trisomy 13).<br><br> 5. Significant medical problems in the mother as reported by the mother and assessed<br> for significance by PI Lumeng (i.e., cancer, lupus)<br><br> 6. Mother or infant taking medications likely to have significant effect on biological<br> measures in study (e.g., steroids)<br><br> 7. Family lives more than 1.5 hour driving distance from the University of Michigan.<br> This is necessary to ensure study feasibility.<br><br> 8. Family plans to move outside 1.5 hour driving distance from the University of<br> Michigan before end of age 36-month data collection window. This is necessary to<br> ensure study feasibility.<br><br> 9. Child is product of multiple gestation (i.e., twins, triplets)<br><br> 10. Significant complications for mother or infant during the pregnancy as assessed by<br> PI Lumeng (e.g., eclampsia, preterm premature rupture of membranes)<br><br> 11. Significant complications for mother or infant during the perinatal period as<br> assessed by PI Lumeng (e.g., sepsis, hemorrhage requiring transfusion, persistent<br> pulmonary hypertension of the newborn)<br><br>All participants must be enrolled in all parts of the Mother-Baby study (1 Observational<br>study and 4 Clinical Trials)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight-for-length z-score
- Secondary Outcome Measures
Name Time Method