<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/NCT03229161</url>
  </required_header>
  <id_info>
    <org_study_id>CT20160156</org_study_id>
    <secondary_id>S-20160156</secondary_id>
    <secondary_id>16/40511</secondary_id>
    <nct_id>NCT03229161</nct_id>
  </id_info>
  <brief_title>Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus</brief_title>
  <official_title>Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Danish Center for Strategic Research on Type 2 Diabetes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Danish Center for Strategic Research on Type 2 Diabetes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well-known that regular physical activity (PA) can improve glycemic control and&#xD;
      physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in&#xD;
      patients with gestational diabetes mellitus (GDM) are limited. Interval walking training&#xD;
      (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow&#xD;
      walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM&#xD;
      patients, and to examine the effects of IWT on glycemic control, PA levels and physical&#xD;
      fitness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gestational diabetes mellitus (GDM), defined as glucose intolerance and thus hyperglycemia&#xD;
      with onset or first recognition during pregnancy, is steadily increasing in prevalence. In&#xD;
      Denmark, the prevalence of GDM is around 2-3% of all pregnancies. GDM is associated with&#xD;
      several adverse perinatal and maternal outcomes why early recognition and diagnosis is&#xD;
      important. Early diagnosis and relevant treatment can prevent adverse outcomes of the baby&#xD;
      and mother, such as macrosomia, shoulder dystocia, preeclampsia and hypoglycemia.&#xD;
&#xD;
      The glucose levels will often normalize shortly after birth; however, up to 50% of all women&#xD;
      in Denmark diagnosed with GDM develop T2D during the first 10 years after the pregnancy, have&#xD;
      a threefold risk of developing metabolic syndrome2 10, while the recurrence risk of&#xD;
      developing GDM in subsequent pregnancies varies between 30-84%. Furthermore, long term&#xD;
      increased risks for children born with macrosomia or by a mother with GDM include&#xD;
      cardiovascular disease, obesity and T2D.&#xD;
&#xD;
      Glycemic control is a key factor in combatting the severe effects related to poorly&#xD;
      controlled GDM. Management of GDM in Denmark consists of regular BG self-monitoring, dietary&#xD;
      modifications, and in some cases insulin treatment. Additionally, obstetric control visits&#xD;
      and PA advices are also a part of the standard GDM care program.&#xD;
&#xD;
      Compared to non-pregnant women, pregnant women must be more careful in relation to especially&#xD;
      the type of PA, why supervised exercise is often recommended in order to ensure safe and&#xD;
      correct guidance. This is a heavy economic burden, why a structured, non-supervised type of&#xD;
      PA with low a risk of injury, possibly high compliance and continuous monitoring would be&#xD;
      preferable. Interval walking training (IWT) is a lenient type of structured, non-supervised&#xD;
      PA. This type of PA is associated with an improved glucose regulation in patients with T2D&#xD;
      after 4 months of IWT 5 times weekly (60 min./session) (Karstoft et al., 2013). Due to&#xD;
      similar metabolic dysregulations in patients with T2D and GDM, the investigators are apt to&#xD;
      believe that IWT, if feasible, can improve glycemic control in GDM patients. Furthermore, it&#xD;
      is obvious to believe that IWT can be implemented as regular PA in GDM patients, as one study&#xD;
      has shown that pregnant women mostly prefer walking as a type of PA during pregnancy.&#xD;
&#xD;
      This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a&#xD;
      control- (Con) or IWT-group. Both groups will follow the standard GDM care program at Odense&#xD;
      University Hospital. Additionally, the IWT-group is prescribed three weekly IWT sessions of&#xD;
      40-50 minutes each for 6 weeks. Each IWT session is guided and controlled by the smartphone&#xD;
      application 'InterWalk', which individualize the training intensity to current fitness level&#xD;
      of the patient through an on-board fitness test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a control- (Con) or IWT-group. Patients in both the IWT- and Con-group follows the standardized GDM care program for GDM patients at OUH through the 6-week intervention period, which consists of instruction of self-monitoring of BG levels, dietary guidance, and in some cases, insulin treatment. Additionally, the program also consists of close obstetric control visits and exercise guidance. All patients are instructed not to start any new type of PA after inclusion and continue their lives without any changes.&#xD;
Patients randomized to the IWT-group goes through a 6-week non-supervised IWT-program, where they are prescribed to conduct 3 IWT sessions per week of 40-50 minutes each.&#xD;
Before and after the 6-week intervention, maternal blood glucose (BG) levels is measured by continuous glucose monitoring, PA level measured using accelerometers and physical fitness measured using two walking tests.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance to the prescribed IWT-intervention</measure>
    <time_frame>After the 6-week intervention period</time_frame>
    <description>Compliance defined as adherence to the prescribed IWT-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance to the prescribed IWT-intervention</measure>
    <time_frame>After the 6-week intervention period</time_frame>
    <description>Compliance defined as the quality of the the IWT sessions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Before and after the 6-week intervention period</time_frame>
    <description>Blood glucose variations measured by 48-hour continuous glucose monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>7 days before and after the 6-week intervention period, and the first and last 5 days during the 6-week intervention period</time_frame>
    <description>Physical activity level measured by accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>Before and after the 6-week intervention period</time_frame>
    <description>Physical fitness measured by the on-board fitness test in the InterWalk application and a 6-minute walking test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Before and after the 6-week intervention period</time_frame>
    <description>30 minutes systolic and diastolic Blood Pressure (BP) together with pulse wave velocity (PWV) was measured by using the Mobil-O Graph® PWA device. BP and PWV was measured every 3 minutes for 30 minutes in a sitting position with the assessor only being in the room during the first measurement to ensure adequate quality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical and mental health</measure>
    <time_frame>Before and after the 6-week intervention period</time_frame>
    <description>Perceived physical and mental health was measured using the SF-12 questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Before and after the 6-week intervention period</time_frame>
    <description>Body height and body weight were objectively measured. Height was measured in an upright standing position without shoes by using a stadiometer. Weight was also measured in a standing position without shoes by using a digital scale. Height and weight was measured to the nearest 0.5 centimeter and 0.1 kilo respectively. BMI was calculated based on measured height and weight</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>IWT-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IWT-group follows the standardized GDM care program for GDM patients at OUH and is prescribed to a 6-week non-supervised IWT-program consisting of 3 IWT sessions per week of 40-50 minutes each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Con-group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The con-group follows the standardized GDM care program for GDM patients at OUH</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IWT-group</intervention_name>
    <arm_group_label>IWT-group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with GDM by a 2 hour oral glucose tolerance test with a BG level of&#xD;
             &gt;9.00mmol/l at 2 hours&#xD;
&#xD;
          -  Danish speaking&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Live &lt;20 kilometers from Odense city center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pelvic pains&#xD;
&#xD;
          -  Untreated depression&#xD;
&#xD;
          -  Walking disabilities&#xD;
&#xD;
          -  Pregnancy-related complications&#xD;
&#xD;
          -  &gt;32 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>As only women can be diagnosed with gestational diabetes mellitus, only women are eligible in participating in the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Danish Centre of strategic research of type 2 diabetes</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Kathrine Kjaer</investigator_full_name>
    <investigator_title>Principal investigator</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>Pregnancy in Diabetics</mesh_term>
    <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/NCT03229161
org study id: CT20160156
secondary id: S-20160156
secondary id: 16/40511
nct id: NCT03229161
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is well-known that regular physical activity (PA) can improve glycemic control and
      physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in
      patients with gestational diabetes mellitus (GDM) are limited. Interval walking training
      (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow
      walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM
      patients, and to examine the effects of IWT on glycemic control, PA levels and physical
      fitness.
Gestational diabetes mellitus (GDM), defined as glucose intolerance and thus hyperglycemia
      with onset or first recognition during pregnancy, is steadily increasing in prevalence. In
      Denmark, the prevalence of GDM is around 2-3% of all pregnancies. GDM is associated with
      several adverse perinatal and maternal outcomes why early recognition and diagnosis is
      important. Early diagnosis and relevant treatment can prevent adverse outcomes of the baby
      and mother, such as macrosomia, shoulder dystocia, preeclampsia and hypoglycemia.

      The glucose levels will often normalize shortly after birth; however, up to 50% of all women
      in Denmark diagnosed with GDM develop T2D during the first 10 years after the pregnancy, have
      a threefold risk of developing metabolic syndrome2 10, while the recurrence risk of
      developing GDM in subsequent pregnancies varies between 30-84%. Furthermore, long term
      increased risks for children born with macrosomia or by a mother with GDM include
      cardiovascular disease, obesity and T2D.

      Glycemic control is a key factor in combatting the severe effects related to poorly
      controlled GDM. Management of GDM in Denmark consists of regular BG self-monitoring, dietary
      modifications, and in some cases insulin treatment. Additionally, obstetric control visits
      and PA advices are also a part of the standard GDM care program.

      Compared to non-pregnant women, pregnant women must be more careful in relation to especially
      the type of PA, why supervised exercise is often recommended in order to ensure safe and
      correct guidance. This is a heavy economic burden, why a structured, non-supervised type of
      PA with low a risk of injury, possibly high compliance and continuous monitoring would be
      preferable. Interval walking training (IWT) is a lenient type of structured, non-supervised
      PA. This type of PA is associated with an improved glucose regulation in patients with T2D
      after 4 months of IWT 5 times weekly (60 min./session) (Karstoft et al., 2013). Due to
      similar metabolic dysregulations in patients with T2D and GDM, the investigators are apt to
      believe that IWT, if feasible, can improve glycemic control in GDM patients. Furthermore, it
      is obvious to believe that IWT can be implemented as regular PA in GDM patients, as one study
      has shown that pregnant women mostly prefer walking as a type of PA during pregnancy.

      This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a
      control- (Con) or IWT-group. Both groups will follow the standard GDM care program at Odense
      University Hospital. Additionally, the IWT-group is prescribed three weekly IWT sessions of
      40-50 minutes each for 6 weeks. Each IWT session is guided and controlled by the smartphone
      application 'InterWalk', which individualize the training intensity to current fitness level
      of the patient through an on-board fitness test.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This open-label randomized controlled trial aims to enroll 20 patients randomized (1:1) to a control- (Con) or IWT-group. Patients in both the IWT- and Con-group follows the standardized GDM care program for GDM patients at OUH through the 6-week intervention period, which consists of instruction of self-monitoring of BG levels, dietary guidance, and in some cases, insulin treatment. Additionally, the program also consists of close obstetric control visits and exercise guidance. All patients are instructed not to start any new type of PA after inclusion and continue their lives without any changes.
Patients randomized to the IWT-group goes through a 6-week non-supervised IWT-program, where they are prescribed to conduct 3 IWT sessions per week of 40-50 minutes each.
Before and after the 6-week intervention, maternal blood glucose (BG) levels is measured by continuous glucose monitoring, PA level measured using accelerometers and physical fitness measured using two walking tests.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Compliance to the prescribed IWT-intervention
time frame: After the 6-week intervention period
description: Compliance defined as adherence to the prescribed IWT-intervention
measure: Compliance to the prescribed IWT-intervention
time frame: After the 6-week intervention period
description: Compliance defined as the quality of the the IWT sessions
measure: Glycemic control
time frame: Before and after the 6-week intervention period
description: Blood glucose variations measured by 48-hour continuous glucose monitoring
measure: Physical activity level
time frame: 7 days before and after the 6-week intervention period, and the first and last 5 days during the 6-week intervention period
description: Physical activity level measured by accelerometers
measure: Physical fitness
time frame: Before and after the 6-week intervention period
description: Physical fitness measured by the on-board fitness test in the InterWalk application and a 6-minute walking test
measure: Blood pressure
time frame: Before and after the 6-week intervention period
description: 30 minutes systolic and diastolic Blood Pressure (BP) together with pulse wave velocity (PWV) was measured by using the Mobil-O Graph® PWA device. BP and PWV was measured every 3 minutes for 30 minutes in a sitting position with the assessor only being in the room during the first measurement to ensure adequate quality.
measure: Physical and mental health
time frame: Before and after the 6-week intervention period
description: Perceived physical and mental health was measured using the SF-12 questionnaire.
measure: BMI
time frame: Before and after the 6-week intervention period
description: Body height and body weight were objectively measured. Height was measured in an upright standing position without shoes by using a stadiometer. Weight was also measured in a standing position without shoes by using a digital scale. Height and weight was measured to the nearest 0.5 centimeter and 0.1 kilo respectively. BMI was calculated based on measured height and weight
arm group label: IWT-group
arm group type: Experimental
description: The IWT-group follows the standardized GDM care program for GDM patients at OUH and is prescribed to a 6-week non-supervised IWT-program consisting of 3 IWT sessions per week of 40-50 minutes each.
arm group label: Con-group
arm group type: No Intervention
description: The con-group follows the standardized GDM care program for GDM patients at OUH
intervention type: Behavioral
intervention name: IWT-group
arm group label: IWT-group
criteria: 
gender: Female
gender based: Yes
gender description: As only women can be diagnosed with gestational diabetes mellitus, only women are eligible in participating in the study.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Kathrine Kjaer
investigator title: Principal investigator
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No