<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/NCT02240420</url>
  </required_header>
  <id_info>
    <org_study_id>CFDA 10.586</org_study_id>
    <nct_id>NCT02240420</nct_id>
  </id_info>
  <brief_title>Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes</brief_title>
  <acronym>Star-Mama</acronym>
  <official_title>Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Francisco Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sonoma Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base&#xD;
      counseling intervention for young Latino women who are at high risk of diabetes. The&#xD;
      intervention will focus at the end of pregnancy and the 9 months post-partum period to&#xD;
      improve education and behavioral counseling on nutrition and other related health topics .&#xD;
&#xD;
      The following hypotheses will be formally tested:&#xD;
&#xD;
      Compared with controls at 9 months post-partum:&#xD;
&#xD;
        1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for&#xD;
           minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);&#xD;
&#xD;
        2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;&#xD;
&#xD;
        3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.&#xD;
&#xD;
      Women in the STAR-MAMA will have lost more weight than women in the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The STAR-MAMA intervention builds on theoretical constructs found in Social Cognitive Theory,&#xD;
      Theory of Planned Behavior, and Theories of Social Support found to be effective in weight&#xD;
      loss, physical activity and dietary change, based on a recent meta-analysis and other&#xD;
      studies. The investigators proposed development of STAR-MAMA will incorporate specific&#xD;
      behavior change techniques associated with these theories, including: &quot;self-regulatory&quot;&#xD;
      intervention techniques (specific goal setting, prompting self-monitoring, providing feedback&#xD;
      on performance, goal review), self-efficacy building intervention techniques (motivational&#xD;
      interviewing, using decisional balance and relapse prevention), individual tailoring&#xD;
      techniques (information on content and resources), and culturally tailored social support,&#xD;
      and which incorporates family needs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">March 10, 2018</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>
    <intervention_model_description>Hybrid type 1 effectiveness implementation design, focusing on weight loss and behavior change outcomes, as well as engagement and acceptability of the intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior change</measure>
    <time_frame>6 month -12 months post-partum</time_frame>
    <description>Women in the intervention arm of the study (Star-Mama) will have behavior changes that lower their risk of developing gestational diabetes in the next pregnancy of type 2 diabetes later in life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>6-12 months post-partum</time_frame>
    <description>Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Life Style counseling (Star-Mama)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Star-Mama intervention group will receive during 6 months weekly phone calls with queries and narratives about health habits. The participant's answers will be sent to a health coach who will follow up with the participant, and develop a plan with the participant to address her needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational Resource Support</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group of the study will receive a set of educational materials with information about their health and the health of their babies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life Style Counseling (Star-Mama)</intervention_name>
    <description>Participants enrolled in the Star-Mama intervention group will receive 1. weekly automated phone calls with prevention-focused queries (e.g., diet, exercise, breastfeeding). 2. If a participant generates a value rated &quot;out of range,&quot; a health coach who receives daily electronic downloads of STAR-Mama responses will call the participant to coach her about the specific health issue. Participants also hear recorded narratives related to their &quot;out of range&quot; reply encouraging behavior change. 3. Call-backs enable coaches to engage patients in goals setting/action plans and providing information about community resources</description>
    <arm_group_label>Life Style counseling (Star-Mama)</arm_group_label>
    <other_name>Star-Mama intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postpartum Latino women (English or Spanish speakers) with history of gestational&#xD;
             diabetes.&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not have type 1 or type 2 diabetes.&#xD;
&#xD;
          -  Do not have access to phone line or a cellphone to receive weekly calls of health&#xD;
             coaching education over the phone.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret A. Handley, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco General Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes prevention in the post-partum</keyword>
  <keyword>Behavior change among Latinas,</keyword>
  <keyword>Health Coaching, Motivational interviewing techniques</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02240420
org study id: CFDA 10.586
nct id: NCT02240420
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base
      counseling intervention for young Latino women who are at high risk of diabetes. The
      intervention will focus at the end of pregnancy and the 9 months post-partum period to
      improve education and behavioral counseling on nutrition and other related health topics .

      The following hypotheses will be formally tested:

      Compared with controls at 9 months post-partum:

        1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for
           minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);

        2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;

        3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.

      Women in the STAR-MAMA will have lost more weight than women in the control group.
The STAR-MAMA intervention builds on theoretical constructs found in Social Cognitive Theory,
      Theory of Planned Behavior, and Theories of Social Support found to be effective in weight
      loss, physical activity and dietary change, based on a recent meta-analysis and other
      studies. The investigators proposed development of STAR-MAMA will incorporate specific
      behavior change techniques associated with these theories, including: "self-regulatory"
      intervention techniques (specific goal setting, prompting self-monitoring, providing feedback
      on performance, goal review), self-efficacy building intervention techniques (motivational
      interviewing, using decisional balance and relapse prevention), individual tailoring
      techniques (information on content and resources), and culturally tailored social support,
      and which incorporates family needs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Hybrid type 1 effectiveness implementation design, focusing on weight loss and behavior change outcomes, as well as engagement and acceptability of the intervention
primary purpose: Prevention
masking: None (Open Label)
measure: Behavior change
time frame: 6 month -12 months post-partum
description: Women in the intervention arm of the study (Star-Mama) will have behavior changes that lower their risk of developing gestational diabetes in the next pregnancy of type 2 diabetes later in life.
measure: Weight loss
time frame: 6-12 months post-partum
description: Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.
arm group label: Life Style counseling (Star-Mama)
arm group type: Active Comparator
description: Star-Mama intervention group will receive during 6 months weekly phone calls with queries and narratives about health habits. The participant's answers will be sent to a health coach who will follow up with the participant, and develop a plan with the participant to address her needs.
arm group label: Educational Resource Support
arm group type: No Intervention
description: Participants in the control group of the study will receive a set of educational materials with information about their health and the health of their babies.
intervention type: Behavioral
intervention name: Life Style Counseling (Star-Mama)
description: Participants enrolled in the Star-Mama intervention group will receive 1. weekly automated phone calls with prevention-focused queries (e.g., diet, exercise, breastfeeding). 2. If a participant generates a value rated "out of range," a health coach who receives daily electronic downloads of STAR-Mama responses will call the participant to coach her about the specific health issue. Participants also hear recorded narratives related to their "out of range" reply encouraging behavior change. 3. Call-backs enable coaches to engage patients in goals setting/action plans and providing information about community resources
arm group label: Life Style counseling (Star-Mama)
other name: Star-Mama intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Margaret A. Handley, MPH, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2