<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/NCT01687634</url>
  </required_header>
  <id_info>
    <org_study_id>P3018725</org_study_id>
    <nct_id>NCT01687634</nct_id>
  </id_info>
  <brief_title>Home Visiting for Low Income, Pregnant Women</brief_title>
  <official_title>Home Visiting for Low Income, Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>W.K. Kellogg Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for HIV Identification, Prevention, and Treatment Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive&#xD;
      health care model that increases the opportunities for families to make healthy choices -- in&#xD;
      their homes, schools &amp; communities. The project's key element is: Lay community health&#xD;
      workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to&#xD;
      pregnant mothers &amp; newly-delivered mothers who have agreed to participate in the research&#xD;
      study.&#xD;
&#xD;
      Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months&#xD;
      post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use&#xD;
      during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare&#xD;
      adherence.&#xD;
&#xD;
      Investigators will implement the study with 6 MMs, who will maintain an average caseload of&#xD;
      16 women each across an 18-month period. Each participant will be visited (or receive the&#xD;
      intervention by telephone) twice per month.&#xD;
&#xD;
      Separate Assessment Team members will conduct assessments at: Baseline, within a week of&#xD;
      birth of the target child, and 6 months from birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After participant mothers have been recruited, screened, and consented into the study, each&#xD;
      woman will be contacted by a member of the Assessment Team to schedule the in-home Baseline&#xD;
      Assessment. The Baseline Assessment will take approximately 90 minutes to complete.&#xD;
&#xD;
      Follow-up Assessments will take place: within a week of delivery and 6 months after delivery.&#xD;
      Interviews will be audio-recorded for quality assurance purposes. The domains of the&#xD;
      Follow-up Assessments will be 1) maternal weight, height, and eating and exercise routines;&#xD;
      2) feeding routines, style, and frequency; 3) substance use; and 4) adherence to health care&#xD;
      prenatally and postnatally, immunizations, and illnesses for mothers and babies. Secondarily,&#xD;
      investigators will assess the mother's pregnancy, general health, mental health, social&#xD;
      support, the father of the child, use of alternative medicine and health care, reproductive&#xD;
      health, HIV, relationships and violence, baseline knowledge of antenatal health, baseline&#xD;
      knowledge of delivery health, and baseline stated future plans.&#xD;
&#xD;
      All in-home interviews will take place in a private room or area of the participant's home.&#xD;
      If an in-home interview is not practical or appropriate for any reason, the interviewer will&#xD;
      conduct the interview at the Robert F. Kennedy Community Schools campus, UCLA, or another&#xD;
      site.&#xD;
&#xD;
      Assessment team in-home interviews will be audio-recorded for quality assurance &amp; supervision&#xD;
      purposes. Telephone interviews will not be audio-recorded.&#xD;
&#xD;
      ----------------------------------------------------&#xD;
&#xD;
      IN-HOME (OR TELEPHONE) MENTOR MOTHER INTERVENTION VISITS:&#xD;
&#xD;
      Each participant will be assigned to a Mentor Mother (MM). Participants will receive a series&#xD;
      of twice-monthly, pre- and post-natal, in-home (or telephone call) intervention visits, for&#xD;
      the study period of 12 months, from her assigned MM. The MM will measure the mother's height&#xD;
      &amp; weight at each intervention home visit, then proceed to deliver one of the Intervention&#xD;
      Topics (e.g. nutrition, substance use awareness, infant development etc.). After the baby is&#xD;
      born, the Mentor Mother will continue to record the mother's weight and height, and will also&#xD;
      measure and weigh the infant, entering that data into the study mobile phone. These&#xD;
      intervention visits (or phone calls) will last for approximately 1 hour each. The MM will&#xD;
      address any concerns or questions the mother has, provide referrals to community resources as&#xD;
      necessary, and leave handouts for the participant mother based on the day's intervention&#xD;
      topic and/or the participant mother's questions that day.&#xD;
&#xD;
      ----------------------------------------------------&#xD;
&#xD;
      HEALTH INFORMATION MAILINGS:&#xD;
&#xD;
      Pregnant women will receive twice-monthly mailing that will provide information about&#xD;
      pregnancy, breastfeeding, nutrition, and infant care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>Six months post-birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal BMI</measure>
    <time_frame>Six months post-birth</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol, tobacco, and drug use in pregnancy</measure>
    <time_frame>one week post-birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference</measure>
    <time_frame>one week post-birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference</measure>
    <time_frame>six months post-birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to prenatal clinic visits</measure>
    <time_frame>one week post-birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to well-baby clinic visits</measure>
    <time_frame>six months post-birth</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Pregnant Women</condition>
  <condition>Nutrition During Pregnancy</condition>
  <condition>Breast Feeding</condition>
  <condition>Newborns</condition>
  <arm_group>
    <arm_group_label>In-home Mentor Mother visits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Information Mailings</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>In-home Mentor Mother visits</intervention_name>
    <description>Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.</description>
    <arm_group_label>In-home Mentor Mother visits</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Information Mailings</intervention_name>
    <description>Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.</description>
    <arm_group_label>Health Information Mailings</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  Currently pregnant;&#xD;
&#xD;
          -  Living in the Pico/Union Koreatown community;&#xD;
&#xD;
          -  Ability to provide informed consent;&#xD;
&#xD;
          -  Speaks English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age;&#xD;
&#xD;
          -  Not currently pregnant;&#xD;
&#xD;
          -  Not living in the Pico/Union Koreatown community;&#xD;
&#xD;
          -  Unable to provide informed consent;&#xD;
&#xD;
          -  Does not speak English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Jane Rotheram-Borus, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert F. Kennedy Schools</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>May 12, 2017</last_update_submitted>
  <last_update_submitted_qc>May 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Mary Jane Rotheram-Borus</investigator_full_name>
    <investigator_title>Director, Global Center for Children and Families</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>home healthcare visits</keyword>
  <keyword>breast feeding</keyword>
  <keyword>nutrition</keyword>
  <keyword>community health workers</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be be made available on the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS) website.</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/NCT01687634
org study id: P3018725
nct id: NCT01687634
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive
      health care model that increases the opportunities for families to make healthy choices -- in
      their homes, schools & communities. The project's key element is: Lay community health
      workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to
      pregnant mothers & newly-delivered mothers who have agreed to participate in the research
      study.

      Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months
      post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use
      during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare
      adherence.

      Investigators will implement the study with 6 MMs, who will maintain an average caseload of
      16 women each across an 18-month period. Each participant will be visited (or receive the
      intervention by telephone) twice per month.

      Separate Assessment Team members will conduct assessments at: Baseline, within a week of
      birth of the target child, and 6 months from birth.
After participant mothers have been recruited, screened, and consented into the study, each
      woman will be contacted by a member of the Assessment Team to schedule the in-home Baseline
      Assessment. The Baseline Assessment will take approximately 90 minutes to complete.

      Follow-up Assessments will take place: within a week of delivery and 6 months after delivery.
      Interviews will be audio-recorded for quality assurance purposes. The domains of the
      Follow-up Assessments will be 1) maternal weight, height, and eating and exercise routines;
      2) feeding routines, style, and frequency; 3) substance use; and 4) adherence to health care
      prenatally and postnatally, immunizations, and illnesses for mothers and babies. Secondarily,
      investigators will assess the mother's pregnancy, general health, mental health, social
      support, the father of the child, use of alternative medicine and health care, reproductive
      health, HIV, relationships and violence, baseline knowledge of antenatal health, baseline
      knowledge of delivery health, and baseline stated future plans.

      All in-home interviews will take place in a private room or area of the participant's home.
      If an in-home interview is not practical or appropriate for any reason, the interviewer will
      conduct the interview at the Robert F. Kennedy Community Schools campus, UCLA, or another
      site.

      Assessment team in-home interviews will be audio-recorded for quality assurance & supervision
      purposes. Telephone interviews will not be audio-recorded.

      ----------------------------------------------------

      IN-HOME (OR TELEPHONE) MENTOR MOTHER INTERVENTION VISITS:

      Each participant will be assigned to a Mentor Mother (MM). Participants will receive a series
      of twice-monthly, pre- and post-natal, in-home (or telephone call) intervention visits, for
      the study period of 12 months, from her assigned MM. The MM will measure the mother's height
      & weight at each intervention home visit, then proceed to deliver one of the Intervention
      Topics (e.g. nutrition, substance use awareness, infant development etc.). After the baby is
      born, the Mentor Mother will continue to record the mother's weight and height, and will also
      measure and weigh the infant, entering that data into the study mobile phone. These
      intervention visits (or phone calls) will last for approximately 1 hour each. The MM will
      address any concerns or questions the mother has, provide referrals to community resources as
      necessary, and leave handouts for the participant mother based on the day's intervention
      topic and/or the participant mother's questions that day.

      ----------------------------------------------------

      HEALTH INFORMATION MAILINGS:

      Pregnant women will receive twice-monthly mailing that will provide information about
      pregnancy, breastfeeding, nutrition, and infant care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Exclusive breastfeeding
time frame: Six months post-birth
measure: Maternal BMI
time frame: Six months post-birth
measure: Alcohol, tobacco, and drug use in pregnancy
time frame: one week post-birth
measure: World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
time frame: one week post-birth
measure: World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
time frame: six months post-birth
measure: Adherence to prenatal clinic visits
time frame: one week post-birth
measure: Adherence to well-baby clinic visits
time frame: six months post-birth
arm group label: In-home Mentor Mother visits
arm group type: Experimental
description: Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.
arm group label: Health Information Mailings
arm group type: Experimental
description: Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
intervention type: Behavioral
intervention name: In-home Mentor Mother visits
description: Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.
arm group label: In-home Mentor Mother visits
intervention type: Behavioral
intervention name: Health Information Mailings
description: Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
arm group label: Health Information Mailings
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Jane Rotheram-Borus, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Mary Jane Rotheram-Borus
investigator title: Director, Global Center for Children and Families
sharing ipd: Yes
ipd description: Data will be be made available on the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS) website.