xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039878</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00227836</org_study_id>
      <secondary_id>R01DK134979</secondary_id>
      <nct_id>NCT06039878</nct_id>
    </id_info>
    <brief_title>Mother-Baby Study - Observational</brief_title>
    <official_title>Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The rate of weight gain in the first year of life is risk factor for future obesity. The&#xD;
        study will test (1) a model of l mechanisms underlying the development of emotion,&#xD;
        attachment, and nutritive intake; and (2) the association with maternal feeding behavior,&#xD;
        child eating behavior, dietary intake, and adiposity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Weight-for-length z-score</measure>
      <time_frame>Up to 36 months (infant age)</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Obesity, Childhood</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
      <description>The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Bonding-Evoked Oxytocin</intervention_name>
      <description>Mother participates in bonding activity with infant at ages 1, 3, and 6 months</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Distress Relieving Effects of Sucrose</intervention_name>
      <description>Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Hedonic Response to Sucrose</intervention_name>
      <description>Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Typical versus Challenging Feeding-Social</intervention_name>
      <description>Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not.</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Caloric Compensation-Social</intervention_name>
      <description>Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not.</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)</intervention_name>
      <description>When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months.</description>
      <arm_group_label>Mother-Infant Dyad</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The researchers will enroll 120 infants and their mothers (120 dyads, 240 total&#xD;
          participants). Infants will be of both genders and mothers will be of female gender only.&#xD;
          Infants will enroll at 1 month and participate to age 36 months.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          To be eligible to participate in this study, they mother-child dyad must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form by mother for herself and infant&#xD;
  &#xD;
            2. Stated willingness by mother to comply with all study procedures and availability for&#xD;
               the duration of the study&#xD;
  &#xD;
            3. Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and&#xD;
               child's birth date&#xD;
  &#xD;
            4. Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th&#xD;
               percentile) for gestational age and sex based on US Natality Data set.&#xD;
  &#xD;
            5. Mother is biological mother both genetically and gestationally by maternal report&#xD;
               (i.e., conception with her own (versus donor) egg and she was pregnant (versus a&#xD;
               surrogate)&#xD;
  &#xD;
            6. Biological mother is legal guardian by maternal report&#xD;
  &#xD;
            7. Biological mother is full time custodial guardian by maternal report (versus sharing&#xD;
               custody such that infant does not live with her full time)&#xD;
  &#xD;
            8. Infant is the mother's first live birth (i.e., first born) by maternal report&#xD;
  &#xD;
            9. Infant has fed at least 2.0 ounces in one feeding from an artificial nipple and bottle&#xD;
               by maternal report or mother reports planning to do prior to first task requiring&#xD;
               artificial nipple and bottle during age 1.0 month data collection window&#xD;
  &#xD;
          Any dyad who meets any of the following criteria will be excluded from participation in&#xD;
          this study:&#xD;
  &#xD;
            1. Limited English proficiency in the mother; this is necessary because the&#xD;
               questionnaires have only been validated in English-speaking populations.&#xD;
  &#xD;
            2. Participation in another study involving treatment or intervention focused on mother&#xD;
               or child emotion or attachment, child eating behavior, child dietary intake, or child&#xD;
               growth&#xD;
  &#xD;
            3. Mother &lt; 18.0 years old at time of consent prior to infant's age 1.0 month data&#xD;
               collection window&#xD;
  &#xD;
            4. Significant medical problems in the child or known diagnosis as reported by the mother&#xD;
               that has significant potential to affect current or future eating, growth or&#xD;
               development in the child as evaluated by PI Lumeng (e.g., cystic fibrosis, cleft&#xD;
               palate, trisomy 13).&#xD;
  &#xD;
            5. Significant medical problems in the mother as reported by the mother and assessed for&#xD;
               significance by PI Lumeng (i.e., cancer, lupus)&#xD;
  &#xD;
            6. Mother or infant taking medications likely to have significant effect on biological&#xD;
               measures in study (e.g., steroids)&#xD;
  &#xD;
            7. Family lives more than 1.5 hour driving distance from the University of Michigan. This&#xD;
               is necessary to ensure study feasibility.&#xD;
  &#xD;
            8. Family plans to move outside 1.5 hour driving distance from the University of Michigan&#xD;
               before end of age 36-month data collection window. This is necessary to ensure study&#xD;
               feasibility.&#xD;
  &#xD;
            9. Child is product of multiple gestation (i.e., twins, triplets)&#xD;
  &#xD;
           10. Significant complications for mother or infant during the pregnancy as assessed by PI&#xD;
               Lumeng (e.g., eclampsia, preterm premature rupture of membranes)&#xD;
  &#xD;
           11. Significant complications for mother or infant during the perinatal period as assessed&#xD;
               by PI Lumeng (e.g., sepsis, hemorrhage requiring transfusion, persistent pulmonary&#xD;
               hypertension of the newborn)&#xD;
  &#xD;
          All participants must be enrolled in all parts of the Mother-Baby study (1 Observational&#xD;
          study and 4 Clinical Trials)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Days</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julie Lumeng, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alex Jeanpierre</last_name>
      <phone>734-647-1126</phone>
      <email>ajeanp@umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alex Jeanpierre</last_name>
        <phone>734-647-1126</phone>
        <email>ajeanp@umich.edu</email>
      </contact>
      <investigator>
        <last_name>Julie Lumeng, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Julie Lumeng</investigator_full_name>
      <investigator_title>Associate Vice President for Research-Clinical and Human Subjects Research, Office of Research, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School</investigator_title>
    </responsible_party>
    <keyword>weight gain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oxytocin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039878
  org study id: HUM00227836
  secondary id: R01DK134979
  nct id: NCT06039878
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Case-Only
  time perspective: Prospective
  measure: Weight-for-length z-score
  time frame: Up to 36 months (infant age)
  arm group label: Mother-Infant Dyad
  description: The researchers will enroll 120 infants and their mothers (120 dyads, 240 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 120. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
  intervention type: Behavioral
  intervention name: Bonding-Evoked Oxytocin
  description: Mother participates in bonding activity with infant at ages 1, 3, and 6 months
  arm group label: Mother-Infant Dyad
  intervention type: Behavioral
  intervention name: Distress Relieving Effects of Sucrose
  description: Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition
  arm group label: Mother-Infant Dyad
  intervention type: Behavioral
  intervention name: Hedonic Response to Sucrose
  description: Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months
  arm group label: Mother-Infant Dyad
  intervention type: Behavioral
  intervention name: Typical versus Challenging Feeding-Social
  description: Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not.
  arm group label: Mother-Infant Dyad
  intervention type: Behavioral
  intervention name: Caloric Compensation-Social
  description: Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not.
  arm group label: Mother-Infant Dyad
  intervention type: Behavioral
  intervention name: Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)
  description: When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months.
  arm group label: Mother-Infant Dyad
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Days
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Julie Lumeng, MD
  role: Study Chair
  affiliation: University of Michigan
  last name: Alex Jeanpierre
  phone: 734-647-1126
  email: ajeanp@umich.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Julie Lumeng
  investigator title: Associate Vice President for Research-Clinical and Human Subjects Research, Office of Research, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School
  mesh term: Obesity
  mesh term: Pediatric Obesity
  mesh term: Oxytocin
  sharing ipd: No