<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/NCT03033459</url>
  </required_header>
  <id_info>
    <org_study_id>1605123038</org_study_id>
    <nct_id>NCT03033459</nct_id>
  </id_info>
  <brief_title>Prenatal Lactation-Focused Motivational Interviewing</brief_title>
  <official_title>Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breastfeeding is good for the health of both mother and baby, but many women do not&#xD;
      breastfeed, or do not breastfeed for as long as the participant would like. The purpose of&#xD;
      this study is to compare two types of interventions on how each impacts breastfeeding. The&#xD;
      interventions will be given during the third trimester of pregnancy, and the intervention is&#xD;
      individual (i.e., one therapist and one participant). The first intervention is Motivational&#xD;
      Interviewing, a type of counseling. The second intervention, or &quot;control group,&quot; is education&#xD;
      on how babies grow and develop. There general aims of this study are to compare women in the&#xD;
      Motivational Interviewing group and control group on how the participants plan to feed the&#xD;
      babies, how much the participants learn about and the participants opinions about&#xD;
      breastfeeding, and how much the participants learn about how babies grow and develop. In&#xD;
      addition, the groups will be compared as to whether the participants start breastfeeding, and&#xD;
      how the participants are feeding the baby when the baby is one month old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Recruitment efforts will be made in the community via advertisements, online&#xD;
           advertisements (e.g., Craigslist, Facebook), and in-person at various clinics and health&#xD;
           fairs in the geographic area.&#xD;
&#xD;
        2. Prospective participants will contact the investigators via email or by calling the&#xD;
           study phone number listed on the advertisements or verbally expressing interest&#xD;
           in-person.&#xD;
&#xD;
        3. Once a participant indicates interest by contacting study personnel, a 5-minute&#xD;
           screening interview will be conducted with the prospective participant using the&#xD;
           screening questionnaire to ensure eligibility criteria are met. For those who do not&#xD;
           qualify or agree to participate, the age and reason for non-qualification or declination&#xD;
           to participate will be recorded; any other data will be destroyed by shredding or&#xD;
           electronic shredding. For those who do qualify, name and contact information will be&#xD;
           kept confidential and maintained in a locked room.&#xD;
&#xD;
        4. Participants will be asked to rate on a scale of -10 to +10 about the certainty that the&#xD;
           participants will provide exclusive breastmilk to the babies for first six months.&#xD;
           Responses from this item will be used as the covariate in the covariate adaptive&#xD;
           randomization technique.&#xD;
&#xD;
        5. Eligible subjects will be invited to participate in the study, either in an exam room at&#xD;
           West Virginia University's Family Medicine's clinic, participant's home, private room in&#xD;
           the Quin Curtis Center for Psychological Services, or in another agreed-upon community&#xD;
           location (e.g., church). The location of the study procedures is chosen by the&#xD;
           participant.&#xD;
&#xD;
        6. At the start of this session, participants will be given an overview of the study, and&#xD;
           the researcher will go over the consent form with the participant.&#xD;
&#xD;
        7. Following consent procedures, video-recording will begin, and all participants will&#xD;
           complete the prenatal interview. After this interview, participants will complete five&#xD;
           self-report measures, which include the Infant Feeding Knowledge Form, the Iowa Infant&#xD;
           Feeding Attitudes Scale, Brief Breastfeeding Attitudes Questions, Perinatal Anxiety&#xD;
           Screening Scale, and the Knowledge of Infant Development Inventory.&#xD;
&#xD;
        8. Intervention&#xD;
&#xD;
             1. Participants assigned to the MI condition will receive an approximately 45 minute&#xD;
                intervention provided a masters-level supervised psychologist with training in&#xD;
                Motivational Interviewing.&#xD;
&#xD;
             2. Participants who have been randomly assigned to participate in the&#xD;
                attention-control group session will receive approximately 45 minutes of&#xD;
                psychoeducation on typical developmental stages and infant feeding methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">June 7, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breastfeeding status at 1 month postpartum, participant self-report via telephone interview</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Confidence (scale of 0-10)</measure>
    <time_frame>1 day</time_frame>
    <description>Participant self-report of confidence in breastfeeding, scale of 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Importance (scale of 0-10)</measure>
    <time_frame>1 day</time_frame>
    <description>Participant self-report of importance of breastfeeding, scale of 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of infant development- Knowledge of Infant Development Inventory (survey)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to breastfeed Self-reported intention to breastfeed at prenatal time point</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Breast Feeding</condition>
  <condition>Lactation Puerperal Increased</condition>
  <condition>Infant Behavior</condition>
  <condition>Maternal Behavior</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the Motivational Interviewing condition will receive an approximately 45 (± 5) minute intervention provided by a female masters-level supervised psychologist with training in Motivational Interviewing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who have been randomly assigned to participate in the attention-control group session will receive approximately 45 (± 5) minutes of psychoeducation on typical developmental stages and infant feeding methods. The psychoeducation will be provided by a female masters-level supervised psychologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>Motivational Interviewing (MI) is a psychosocial intervention designed to help individuals increase readiness for behavior change by increasing intrinsic motivation and resolving ambivalence. MI founders MI conversations help clients change behavior through identifying and resolving discrepancies between goal behaviors and actual behaviors. Behavior change is promoted through the elicitation of &quot;change talk,&quot; or client-verbalized arguments for change. In MI, change talk is elicited through two major components: the therapeutic relationship, or the embodiment of the &quot;spirit&quot; of MI, and technical skill.</description>
    <arm_group_label>Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation Control</intervention_name>
    <description>Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.</description>
    <arm_group_label>Psychoeducation Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older&#xD;
&#xD;
          2. Female&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. At least 27 weeks pregnant&#xD;
&#xD;
          5. Able to read, write, speak, and understand English&#xD;
&#xD;
          6. Has access to a phone (either mobile or landline)&#xD;
&#xD;
          7. Lives within driving distance of Morgantown, WV, or is willing to travel to a location&#xD;
             that is within driving distance to Morgantown, WV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multiple pregnancy&#xD;
&#xD;
          2. Within one week of due date&#xD;
&#xD;
          3. Has any of the following conditions:&#xD;
&#xD;
               -  Developmental or intellectual disability&#xD;
&#xD;
               -  Schizophrenia&#xD;
&#xD;
               -  Untreated, active tuberculosis&#xD;
&#xD;
               -  Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS)&#xD;
&#xD;
               -  Human T-cell lymphotropic virus type I or type II&#xD;
&#xD;
               -  History of lumpectomy or radiation to breast&#xD;
&#xD;
          4. Uses or is dependent upon any of the following substances (Moretti, Lee, &amp; Ito, 2000):&#xD;
&#xD;
               -  Heroin&#xD;
&#xD;
               -  Cocaine&#xD;
&#xD;
               -  Methamphetamines&#xD;
&#xD;
               -  Marijuana&#xD;
&#xD;
               -  Phencyclidine (PCP)&#xD;
&#xD;
               -  Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone)&#xD;
&#xD;
          5. Undergoing any of the following medications/treatments (American Academy of&#xD;
             Pediatrics, 2001):&#xD;
&#xD;
               -  Antiretrovirals&#xD;
&#xD;
               -  Cancer chemotherapy (e.g., antimetabolites)&#xD;
&#xD;
               -  Radiation therapy&#xD;
&#xD;
               -  Acebutolol&#xD;
&#xD;
               -  Atenolol&#xD;
&#xD;
               -  Bromocriptine&#xD;
&#xD;
               -  Aspirin (salicylates)&#xD;
&#xD;
               -  Ergotamine&#xD;
&#xD;
               -  Lithium&#xD;
&#xD;
               -  Phenobarbital&#xD;
&#xD;
               -  Primidone&#xD;
&#xD;
               -  Sulfasalazine (salicylazosulfapyridine)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel W McNeil, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast feeding</keyword>
  <keyword>motivational interviewing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Galactorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be available upon request to the PI (Daniel McNeil, PhD) upon completion of the study, by emailing dmcneil@wvu.edu AND sehayes@mix.wvu.edu</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/NCT03033459
org study id: 1605123038
nct id: NCT03033459
lead sponsor: 
has dmc: No
Breastfeeding is good for the health of both mother and baby, but many women do not
      breastfeed, or do not breastfeed for as long as the participant would like. The purpose of
      this study is to compare two types of interventions on how each impacts breastfeeding. The
      interventions will be given during the third trimester of pregnancy, and the intervention is
      individual (i.e., one therapist and one participant). The first intervention is Motivational
      Interviewing, a type of counseling. The second intervention, or "control group," is education
      on how babies grow and develop. There general aims of this study are to compare women in the
      Motivational Interviewing group and control group on how the participants plan to feed the
      babies, how much the participants learn about and the participants opinions about
      breastfeeding, and how much the participants learn about how babies grow and develop. In
      addition, the groups will be compared as to whether the participants start breastfeeding, and
      how the participants are feeding the baby when the baby is one month old.
1. Recruitment efforts will be made in the community via advertisements, online
           advertisements (e.g., Craigslist, Facebook), and in-person at various clinics and health
           fairs in the geographic area.

        2. Prospective participants will contact the investigators via email or by calling the
           study phone number listed on the advertisements or verbally expressing interest
           in-person.

        3. Once a participant indicates interest by contacting study personnel, a 5-minute
           screening interview will be conducted with the prospective participant using the
           screening questionnaire to ensure eligibility criteria are met. For those who do not
           qualify or agree to participate, the age and reason for non-qualification or declination
           to participate will be recorded; any other data will be destroyed by shredding or
           electronic shredding. For those who do qualify, name and contact information will be
           kept confidential and maintained in a locked room.

        4. Participants will be asked to rate on a scale of -10 to +10 about the certainty that the
           participants will provide exclusive breastmilk to the babies for first six months.
           Responses from this item will be used as the covariate in the covariate adaptive
           randomization technique.

        5. Eligible subjects will be invited to participate in the study, either in an exam room at
           West Virginia University's Family Medicine's clinic, participant's home, private room in
           the Quin Curtis Center for Psychological Services, or in another agreed-upon community
           location (e.g., church). The location of the study procedures is chosen by the
           participant.

        6. At the start of this session, participants will be given an overview of the study, and
           the researcher will go over the consent form with the participant.

        7. Following consent procedures, video-recording will begin, and all participants will
           complete the prenatal interview. After this interview, participants will complete five
           self-report measures, which include the Infant Feeding Knowledge Form, the Iowa Infant
           Feeding Attitudes Scale, Brief Breastfeeding Attitudes Questions, Perinatal Anxiety
           Screening Scale, and the Knowledge of Infant Development Inventory.

        8. Intervention

             1. Participants assigned to the MI condition will receive an approximately 45 minute
                intervention provided a masters-level supervised psychologist with training in
                Motivational Interviewing.

             2. Participants who have been randomly assigned to participate in the
                attention-control group session will receive approximately 45 minutes of
                psychoeducation on typical developmental stages and infant feeding methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Breastfeeding status at 1 month postpartum, participant self-report via telephone interview
time frame: 1 month
measure: Confidence (scale of 0-10)
time frame: 1 day
description: Participant self-report of confidence in breastfeeding, scale of 0-10
measure: Importance (scale of 0-10)
time frame: 1 day
description: Participant self-report of importance of breastfeeding, scale of 0-10
measure: Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)
time frame: 1 day
measure: Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)
time frame: 1 day
measure: Knowledge of infant development- Knowledge of Infant Development Inventory (survey)
time frame: 1 day
measure: Intention to breastfeed Self-reported intention to breastfeed at prenatal time point
time frame: 1 day
measure: Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview
time frame: 1 month
arm group label: Motivational Interviewing
arm group type: Experimental
description: Participants assigned to the Motivational Interviewing condition will receive an approximately 45 (± 5) minute intervention provided by a female masters-level supervised psychologist with training in Motivational Interviewing.
arm group label: Psychoeducation Control
arm group type: Active Comparator
description: Participants who have been randomly assigned to participate in the attention-control group session will receive approximately 45 (± 5) minutes of psychoeducation on typical developmental stages and infant feeding methods. The psychoeducation will be provided by a female masters-level supervised psychologist.
intervention type: Behavioral
intervention name: Motivational Interviewing
description: Motivational Interviewing (MI) is a psychosocial intervention designed to help individuals increase readiness for behavior change by increasing intrinsic motivation and resolving ambivalence. MI founders MI conversations help clients change behavior through identifying and resolving discrepancies between goal behaviors and actual behaviors. Behavior change is promoted through the elicitation of "change talk," or client-verbalized arguments for change. In MI, change talk is elicited through two major components: the therapeutic relationship, or the embodiment of the "spirit" of MI, and technical skill.
arm group label: Motivational Interviewing
intervention type: Behavioral
intervention name: Psychoeducation Control
description: Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.
arm group label: Psychoeducation Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel W McNeil, PHD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Galactorrhea
sharing ipd: Undecided
ipd description: Data will be available upon request to the PI (Daniel McNeil, PhD) upon completion of the study, by emailing dmcneil@wvu.edu AND sehayes@mix.wvu.edu