<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/NCT01698385</url>
  </required_header>
  <id_info>
    <org_study_id>RADIEL</org_study_id>
    <nct_id>NCT01698385</nct_id>
  </id_info>
  <brief_title>Prevention of Gestational Diabetes Through Lifestyle Modification</brief_title>
  <acronym>RADIEL</acronym>
  <official_title>Prevention of Gestational Diabetes Through Lifestyle Modification (RADIEL) - a Randomized Controlled Multi-centre Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Provincial Health Services Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Karelia, Social and Health Care District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      OVERALL OBJECTIVES:&#xD;
&#xD;
        1. To assess the efficacy of a diet and exercise intervention before and/or during&#xD;
           pregnancy in the prevention of GDM and its fetal complications in women with high&#xD;
           diabetes risk.&#xD;
&#xD;
        2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention&#xD;
           of GDM from a socio-economic point of view. To find out whether the intervention can be&#xD;
           used to reduce health care costs due to GDM and T2DM.&#xD;
&#xD;
        3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention&#xD;
           in the reduction of T2DM incidence among women with prior GDM and their offspring&#xD;
&#xD;
      STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM&#xD;
      or BMI &gt;30 kg/m2. N= 250 + 250.&#xD;
&#xD;
      Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI &gt;30&#xD;
      kg/m2. N= 250 + 250&#xD;
&#xD;
      METHOD The Finnish multi-center randomized controlled intervention trial started in the&#xD;
      maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia&#xD;
      Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited.&#xD;
      Half of the subjects are randomized into the intervention group and the other half act as&#xD;
      controls receiving only standard antenatal care in addition to the laboratory tests taken and&#xD;
      questionnaires administered by the RADIEL study.&#xD;
&#xD;
      The active intervention arm of the study will be carried out in a structured, standardized&#xD;
      manner by diabetes nurses and nutritionists specifically trained for their tasks. The&#xD;
      intervention includes:&#xD;
&#xD;
        1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well&#xD;
           as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on&#xD;
           diet and exercise, setting of specific goals, follow-up of achievements, laboratory&#xD;
           tests and measurements&#xD;
&#xD;
        2. Structured group visits to nutritionist at the moment of enrollment in the study, at the&#xD;
           beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual&#xD;
           visits are booked if needed.&#xD;
&#xD;
        3. Services of physical activity advisors are provided by the study subjects' cities of&#xD;
           residence free of charge to all who wish to receive extra counseling on exercise. If&#xD;
           exercise goals are not met, study subjects book an appointment with the physical&#xD;
           activity advisor.&#xD;
&#xD;
      LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI &gt; 25 and/or&#xD;
      limited weight gain during the first two trimesters in pregnancy if BMI &gt; 30. 2.Exercise: A&#xD;
      minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate&#xD;
      intensity exercise (Borg 11-15). Daily household and/or transportation physical activity.&#xD;
      3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber,&#xD;
      low-fat dairy, vegetable fats; and use of &quot;plate model&quot;. Total energy intake: 1600-1800&#xD;
      kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.&#xD;
&#xD;
      MEASUREMENTS of maternal variables:&#xD;
&#xD;
      AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:&#xD;
&#xD;
      (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT,&#xD;
      fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background&#xD;
      questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1).&#xD;
      Exercise diaries daily for one week.&#xD;
&#xD;
      PREGNANCY At the end of each trimester: (1) The same tests and measurements as in&#xD;
      pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire,&#xD;
      EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at&#xD;
      H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.&#xD;
&#xD;
      POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same&#xD;
      follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post&#xD;
      partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits.&#xD;
      (5) Food and exercise diaries at 12 months post partum.&#xD;
&#xD;
      MEASUREMENTS of child's variables at birth&#xD;
&#xD;
      (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery,&#xD;
      Apgar scores, any perinatal complications, operations, need of neonatal intensive care and&#xD;
      length of hospital. (3) Laboratory tests from cord blood.&#xD;
&#xD;
      TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800&#xD;
      subjects had been recruited to the study. Intervention will continue until 2014 (including&#xD;
      pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts&#xD;
      starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis&#xD;
      starts in autumn of 2013 and results will be reported from 2014 onwards in international&#xD;
      peer-reviewed journals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in oral glucose tolerance test at variable time frames</measure>
    <time_frame>1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in weight at variable time frames</measure>
    <time_frame>1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28 and 34-36, and 4) 6 weeks, 6 months and 12 months post partum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">750</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control, just measurements</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet and exercise counseling</intervention_name>
    <description>diet and exercise counseling, setting of specific goals, follow-up of achievements, laboratory tests and measurements</description>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <other_name>Lifestyle intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese (BMI &gt; 30)&#xD;
&#xD;
          -  previous GDM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  diabetes before pregnancy&#xD;
&#xD;
          -  medication influencing glucose homeostasis&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  physical disability&#xD;
&#xD;
          -  substance abuse&#xD;
&#xD;
          -  severe psychiatric disorders&#xD;
&#xD;
          -  significant co-operation difficulties&#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>Saila B Koivusalo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Helsinki</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital District of Helsinki and Uusimaa</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Saila Koivusalo</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <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>
  </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/NCT01698385
org study id: RADIEL
nct id: NCT01698385
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
OVERALL OBJECTIVES:

        1. To assess the efficacy of a diet and exercise intervention before and/or during
           pregnancy in the prevention of GDM and its fetal complications in women with high
           diabetes risk.

        2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention
           of GDM from a socio-economic point of view. To find out whether the intervention can be
           used to reduce health care costs due to GDM and T2DM.

        3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention
           in the reduction of T2DM incidence among women with prior GDM and their offspring

      STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM
      or BMI >30 kg/m2. N= 250 + 250.

      Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30
      kg/m2. N= 250 + 250

      METHOD The Finnish multi-center randomized controlled intervention trial started in the
      maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia
      Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited.
      Half of the subjects are randomized into the intervention group and the other half act as
      controls receiving only standard antenatal care in addition to the laboratory tests taken and
      questionnaires administered by the RADIEL study.

      The active intervention arm of the study will be carried out in a structured, standardized
      manner by diabetes nurses and nutritionists specifically trained for their tasks. The
      intervention includes:

        1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well
           as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on
           diet and exercise, setting of specific goals, follow-up of achievements, laboratory
           tests and measurements

        2. Structured group visits to nutritionist at the moment of enrollment in the study, at the
           beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual
           visits are booked if needed.

        3. Services of physical activity advisors are provided by the study subjects' cities of
           residence free of charge to all who wish to receive extra counseling on exercise. If
           exercise goals are not met, study subjects book an appointment with the physical
           activity advisor.

      LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or
      limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A
      minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate
      intensity exercise (Borg 11-15). Daily household and/or transportation physical activity.
      3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber,
      low-fat dairy, vegetable fats; and use of "plate model". Total energy intake: 1600-1800
      kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.

      MEASUREMENTS of maternal variables:

      AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:

      (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT,
      fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background
      questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1).
      Exercise diaries daily for one week.

      PREGNANCY At the end of each trimester: (1) The same tests and measurements as in
      pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire,
      EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at
      H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.

      POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same
      follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post
      partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits.
      (5) Food and exercise diaries at 12 months post partum.

      MEASUREMENTS of child's variables at birth

      (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery,
      Apgar scores, any perinatal complications, operations, need of neonatal intensive care and
      length of hospital. (3) Laboratory tests from cord blood.

      TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800
      subjects had been recruited to the study. Intervention will continue until 2014 (including
      pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts
      starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis
      starts in autumn of 2013 and results will be reported from 2014 onwards in international
      peer-reviewed journals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from Baseline in oral glucose tolerance test at variable time frames
time frame: 1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum
measure: Change from Baseline in weight at variable time frames
time frame: 1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28 and 34-36, and 4) 6 weeks, 6 months and 12 months post partum
arm group label: Lifestyle counseling
arm group type: Active Comparator
arm group label: Control, just measurements
arm group type: No Intervention
intervention type: Other
intervention name: Diet and exercise counseling
description: diet and exercise counseling, setting of specific goals, follow-up of achievements, laboratory tests and measurements
arm group label: Lifestyle counseling
other name: Lifestyle intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Saila B Koivusalo, MD
role: Principal Investigator
affiliation: University of Helsinki
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Saila Koivusalo
investigator title: MD PhD
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus