<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/NCT01679210</url>
  </required_header>
  <id_info>
    <org_study_id>NIH 2R01DK064902-06A1</org_study_id>
    <nct_id>NCT01679210</nct_id>
  </id_info>
  <brief_title>Study of a Postpartum Diabetes Prevention Program for Hispanic Women</brief_title>
  <official_title>Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Amherst</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baystate Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Amherst</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this randomized controlled trial is to test the efficacy of a culturally&#xD;
      and linguistically modified, individually-tailored lifestyle intervention to reduce risk&#xD;
      factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a&#xD;
      history of abnormal glucose tolerance during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2)&#xD;
      biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α,&#xD;
      HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood&#xD;
      pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of&#xD;
      postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e.,&#xD;
      physical activity, diet). Eligible Hispanic women will be recruited after routine GDM&#xD;
      screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health&#xD;
      and Wellness (control) intervention (n=150). The intervention will be based on our&#xD;
      efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common&#xD;
      Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based&#xD;
      materials) will be used to deliver the intervention from randomization (29 wks gestation) to&#xD;
      12 months postpartum. Targets of the intervention are to achieve Institute of Medicine&#xD;
      Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist&#xD;
      guidelines for physical activity; and American Diabetes Association guidelines for diet. The&#xD;
      intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses&#xD;
      the specific social, cultural, economic, and physical environmental challenges faced by&#xD;
      underserved Hispanic women. Measures of adherence will include the Pregnancy Physical&#xD;
      Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal&#xD;
      Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The&#xD;
      proposed project builds upon the expertise of the investigative team in conducting randomized&#xD;
      controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876;&#xD;
      S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics&#xD;
      with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be&#xD;
      translated into clinical practice in underserved and minority populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum weight change</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants meeting postpartum weight goals</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Postpartum weight goals will be defined as weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. Weight will be measured on a digital scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Glucose (FG)</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Insulin (FI)</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leptin</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified &quot;two-step&quot; sandwich-type immunoassay (R&amp;D Systems, Minneapolis, MN) (pg/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Adiponectin</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipoprotein Profile</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High Sensitivity C-Reactive Protein</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TNF</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>TNF-receptor II is measured by an ELISA assay from R&amp;D Systems (pg/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin-to-creatinine ratio (ACR)</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetuin-A</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>6 weeks postpartum, 6 months postpartum, 12 months postpartum</time_frame>
    <description>Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage-matched physical activity and diet intervention materials and health education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health and Wellness</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>Stage-matched physical activity and diet intervention materials and health education.</description>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hispanic women with one or more glucose values during the diagnostic test meeting or&#xD;
             exceeding the thresholds defined according to the American Diabetes Association&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of type 1 or type 2 diabetes, heart disease, or chronic renal disease&#xD;
&#xD;
          -  contraindications to postpartum participation in moderate physical activity or a&#xD;
             low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)&#xD;
&#xD;
          -  inability to read English or Spanish at a 6th grade level&#xD;
&#xD;
          -  &lt;18 or &gt;45 yrs of age&#xD;
&#xD;
          -  women carrying multiples&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Chasan-Taber, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Amherst</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.</citation>
    <PMID>24606590</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Amherst</investigator_affiliation>
    <investigator_full_name>Lisa Chasan-Taber</investigator_full_name>
    <investigator_title>Associate Professor of Epidemiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT01679210
org study id: NIH 2R01DK064902-06A1
nct id: NCT01679210
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The overall goal of this randomized controlled trial is to test the efficacy of a culturally
      and linguistically modified, individually-tailored lifestyle intervention to reduce risk
      factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a
      history of abnormal glucose tolerance during pregnancy.
Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2)
      biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α,
      HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood
      pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of
      postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e.,
      physical activity, diet). Eligible Hispanic women will be recruited after routine GDM
      screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health
      and Wellness (control) intervention (n=150). The intervention will be based on our
      efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common
      Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based
      materials) will be used to deliver the intervention from randomization (29 wks gestation) to
      12 months postpartum. Targets of the intervention are to achieve Institute of Medicine
      Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist
      guidelines for physical activity; and American Diabetes Association guidelines for diet. The
      intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses
      the specific social, cultural, economic, and physical environmental challenges faced by
      underserved Hispanic women. Measures of adherence will include the Pregnancy Physical
      Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal
      Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The
      proposed project builds upon the expertise of the investigative team in conducting randomized
      controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876;
      S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics
      with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be
      translated into clinical practice in underserved and minority populations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Postpartum weight change
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale.
measure: Percent of participants meeting postpartum weight goals
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Postpartum weight goals will be defined as weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. Weight will be measured on a digital scale.
measure: Fasting Glucose (FG)
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL).
measure: Fasting Insulin (FI)
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL.
measure: Hemoglobin A1c (HbA1c)
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells.
measure: Leptin
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R&D Systems, Minneapolis, MN) (pg/mL).
measure: Total Adiponectin
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH).
measure: Lipoprotein Profile
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).
measure: High Sensitivity C-Reactive Protein
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L).
measure: TNF
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: TNF-receptor II is measured by an ELISA assay from R&D Systems (pg/mL).
measure: Albumin-to-creatinine ratio (ACR)
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).
measure: Fetuin-A
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).
measure: Physical activity
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week).
measure: Dietary Intake
time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
description: Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls.
arm group label: Lifestyle Intervention
arm group type: Experimental
description: Stage-matched physical activity and diet intervention materials and health education.
arm group label: Health and Wellness
arm group type: No Intervention
description: HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change.
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: Stage-matched physical activity and diet intervention materials and health education.
arm group label: Lifestyle Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Chasan-Taber, ScD
role: Principal Investigator
affiliation: University of Massachusetts, Amherst
facility: 
country: United States
citation: Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.
PMID: 24606590
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Amherst
investigator full name: Lisa Chasan-Taber
investigator title: Associate Professor of Epidemiology
mesh term: Diabetes Mellitus
sharing ipd: No