<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/NCT03297307</url>
  </required_header>
  <id_info>
    <org_study_id>0821-17-EP</org_study_id>
    <nct_id>NCT03297307</nct_id>
  </id_info>
  <brief_title>Mother and Child Health Outcomes After Maternal Bariatric Surgery</brief_title>
  <official_title>Prospective: Mother and Child Health Outcomes After Maternal Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Childhood obesity has been a growing problem with more than 30% of children between 6 and 19&#xD;
      years old being considered overweight or obese. Obese children are at increased risk of&#xD;
      developing diabetes, heart disease, metabolic syndrome, and are susceptible to the&#xD;
      sociological effects of being overweight. Obesity is a multifactorial disease, is often&#xD;
      familial and multi-generational, and studies have shown that parental obesity can increase&#xD;
      the risk of a child becoming obese. Currently, one of the most successful treatment options&#xD;
      for obesity is bariatric surgery. The Nebraska Medicine Bariatric Center offers patients&#xD;
      counseling in improved dietary management, methods to increase physical activity, and&#xD;
      psychological support. As part of the programs standard-of-care, each bariatric surgical&#xD;
      patient receives consultation with a dietician, psychologist, and an exercise physiologist.&#xD;
      We propose that mothers who are enrolled in the surgical weight loss program bring their&#xD;
      children to attend the presurgical specialist consultation. Subjects enrolled in the study&#xD;
      will have their height, weight, and physical activity assessed at preoperative and&#xD;
      postoperative study visits. Study subjects will also complete questionnaires of their&#xD;
      self-reported physical activity and eating habits at these study visits. The goal of this&#xD;
      pilot study is to examine whether this behavioral intervention will have an impact on the&#xD;
      overall health and weight of children whose mothers have received bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective intervention study of female bariatric surgical patients and their&#xD;
      children. The dyads, consisting of one female bariatric patients and one child living in the&#xD;
      home, will be enrolled in the study. Half of the children will attend the dietary, physical&#xD;
      activity, and psychological counseling with the mother prior to her surgery, and the other&#xD;
      half of the children will not receive the behavioral intervention. Outcomes from each&#xD;
      mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively (Visit&#xD;
      BL-2, Visit PO-3, and Visit PO-6). The primary outcome measured from each dyad will be BMI,&#xD;
      and secondary outcomes will be physical activity and energy expenditure (as measured by an&#xD;
      accelerometer at each research study visit) and self-reported diet and physical activity (as&#xD;
      measured by questionnaires completed at each research study visit).&#xD;
&#xD;
      Each bariatric surgical patient will receive a consultation with a dietician, psychologist,&#xD;
      and an exercise physiologist as standard-of-care. These specialist consultations usually take&#xD;
      place sequentially in the same day. The intervention aspect of this study is to include the&#xD;
      child with the mother for these specialist consultations. The dietician will educate the&#xD;
      patient as to dietary modifications that will be needed both before and after bariatric&#xD;
      surgery. The psychologist will review any existing psychological conditions with the patient&#xD;
      and discuss behavioral and pharmaceutical management of these conditions in conjunction with&#xD;
      the bariatric surgery. The exercise physiologist will discuss physical restrictions to&#xD;
      exercise and modifications to an exercise regimen that can be properly performed by the&#xD;
      patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">September 2, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective intervention study of female bariatric surgical patients and their children. The dyads, consisting of one female bariatric patients and one child living in the home, will be enrolled in the study. Half of the children will attend the dietary, physical activity, and psychological counseling with the mother prior to her surgery, and the other half of the children will not receive the behavioral intervention. Outcomes from each mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal weight loss</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>Weight loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child weight loss</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>weight loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal Activity level</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>activity level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Activity Level</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>activity level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>Self-reported diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child diet</measure>
    <time_frame>presurgical, 3 mos, 6 mos</time_frame>
    <description>self-reported diet</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Mother-Child with Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will attend presurgical visits with their mother</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mother-Child Non-Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children will not attend presurgical visits with their mother</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Presurgical Counseling</intervention_name>
    <description>Children will attend the presurgical counseling visits with their mother</description>
    <arm_group_label>Mother-Child with Intervention</arm_group_label>
    <other_name>No Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 19-55 at the time of surgery&#xD;
&#xD;
          2. Consent to provide access to medical records for medical history&#xD;
&#xD;
          3. Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska&#xD;
             Medicine&#xD;
&#xD;
          4. Have children ages 8-17 (at the time of the mother's surgery) living in the home&#xD;
&#xD;
          5. Consent to wear an activity tracker device for 7 days after designated visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Complication of bariatric procedure post-operatively that would significantly affect&#xD;
             weight loss (extended period of TPN, clinically significant leak, major organ failure,&#xD;
             severe protein malnutrition or failure to thrive)&#xD;
&#xD;
          2. Body contouring within the first year (panniculectomy, etc.).&#xD;
&#xD;
          3. Are pregnant or become pregnant during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tiffany Tanner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 2, 2022</last_update_submitted>
  <last_update_submitted_qc>September 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Tiffany Tanner</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual patient data will not be made available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03297307
org study id: 0821-17-EP
nct id: NCT03297307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Childhood obesity has been a growing problem with more than 30% of children between 6 and 19
      years old being considered overweight or obese. Obese children are at increased risk of
      developing diabetes, heart disease, metabolic syndrome, and are susceptible to the
      sociological effects of being overweight. Obesity is a multifactorial disease, is often
      familial and multi-generational, and studies have shown that parental obesity can increase
      the risk of a child becoming obese. Currently, one of the most successful treatment options
      for obesity is bariatric surgery. The Nebraska Medicine Bariatric Center offers patients
      counseling in improved dietary management, methods to increase physical activity, and
      psychological support. As part of the programs standard-of-care, each bariatric surgical
      patient receives consultation with a dietician, psychologist, and an exercise physiologist.
      We propose that mothers who are enrolled in the surgical weight loss program bring their
      children to attend the presurgical specialist consultation. Subjects enrolled in the study
      will have their height, weight, and physical activity assessed at preoperative and
      postoperative study visits. Study subjects will also complete questionnaires of their
      self-reported physical activity and eating habits at these study visits. The goal of this
      pilot study is to examine whether this behavioral intervention will have an impact on the
      overall health and weight of children whose mothers have received bariatric surgery.
This is a prospective intervention study of female bariatric surgical patients and their
      children. The dyads, consisting of one female bariatric patients and one child living in the
      home, will be enrolled in the study. Half of the children will attend the dietary, physical
      activity, and psychological counseling with the mother prior to her surgery, and the other
      half of the children will not receive the behavioral intervention. Outcomes from each
      mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively (Visit
      BL-2, Visit PO-3, and Visit PO-6). The primary outcome measured from each dyad will be BMI,
      and secondary outcomes will be physical activity and energy expenditure (as measured by an
      accelerometer at each research study visit) and self-reported diet and physical activity (as
      measured by questionnaires completed at each research study visit).

      Each bariatric surgical patient will receive a consultation with a dietician, psychologist,
      and an exercise physiologist as standard-of-care. These specialist consultations usually take
      place sequentially in the same day. The intervention aspect of this study is to include the
      child with the mother for these specialist consultations. The dietician will educate the
      patient as to dietary modifications that will be needed both before and after bariatric
      surgery. The psychologist will review any existing psychological conditions with the patient
      and discuss behavioral and pharmaceutical management of these conditions in conjunction with
      the bariatric surgery. The exercise physiologist will discuss physical restrictions to
      exercise and modifications to an exercise regimen that can be properly performed by the
      patient.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This is a prospective intervention study of female bariatric surgical patients and their children. The dyads, consisting of one female bariatric patients and one child living in the home, will be enrolled in the study. Half of the children will attend the dietary, physical activity, and psychological counseling with the mother prior to her surgery, and the other half of the children will not receive the behavioral intervention. Outcomes from each mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively
primary purpose: Treatment
masking: None (Open Label)
measure: Maternal weight loss
time frame: presurgical, 3 mos, 6 mos
description: Weight loss
measure: Child weight loss
time frame: presurgical, 3 mos, 6 mos
description: weight loss
measure: Maternal Activity level
time frame: presurgical, 3 mos, 6 mos
description: activity level
measure: Child Activity Level
time frame: presurgical, 3 mos, 6 mos
description: activity level
measure: Maternal diet
time frame: presurgical, 3 mos, 6 mos
description: Self-reported diet
measure: Child diet
time frame: presurgical, 3 mos, 6 mos
description: self-reported diet
arm group label: Mother-Child with Intervention
arm group type: Experimental
description: Children will attend presurgical visits with their mother
arm group label: Mother-Child Non-Intervention
arm group type: No Intervention
description: Children will not attend presurgical visits with their mother
intervention type: Behavioral
intervention name: Presurgical Counseling
description: Children will attend the presurgical counseling visits with their mother
arm group label: Mother-Child with Intervention
other name: No Intervention
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tiffany Tanner, MD
role: Principal Investigator
affiliation: UNMC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Tiffany Tanner
investigator title: Assistant Professor of Surgery
mesh term: Weight Loss
sharing ipd: No
ipd description: Individual patient data will not be made available to other researchers