<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/NCT03307733</url>
  </required_header>
  <id_info>
    <org_study_id>STH19365</org_study_id>
    <nct_id>NCT03307733</nct_id>
  </id_info>
  <brief_title>Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women</brief_title>
  <acronym>WiP</acronym>
  <official_title>Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Hallam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Hallam University</source>
  <oversight_info>
    <has_dmc>No</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>
      A physical activity feasibility randomised control trial for pregnant, obese women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overweight (defined as BMI ≥25kg/m2) and obesity (defined as BMI ≥30kg/m2) during pregnancy&#xD;
      is becoming more common. Approximately 25-30% of women of childbearing age are obese and&#xD;
      around 50% are overweight at the time of conception. Women who are either overweight or obese&#xD;
      have a much higher risk of adverse pregnancy outcomes. For example, they are more likely to&#xD;
      develop gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, Caesarean&#xD;
      section and other complications. Recent research suggests that overweight and obese pregnant&#xD;
      women are less active than normal weight ( BMI≤ 25kg/m2) pregnant women and also that the&#xD;
      level of physical activity decreases throughout pregnancy. The evidence also suggests that&#xD;
      maintaining a good level of physical activity can reduce the risks of adverse pregnancy&#xD;
      outcomes. A large study which looked at the most preferred types of physical activity&#xD;
      identified that walking and swimming were the most preferred types of physical activity by&#xD;
      pregnant women. Although there is an association between walking at a brisk pace and a&#xD;
      reduced risk of gestational diabetes, there is no definitive conclusion on the effectiveness&#xD;
      of walking interventions. The investigators are proposing this feasibility study in order to&#xD;
      find out whether a walking intervention can be implemented during pregnancy in the obese&#xD;
      population to reduce adverse pregnancy health outcomes. The current study will investigate&#xD;
      whether a Fitibit Pedometer and a Social networking Site (Facebook) can be used to encourage&#xD;
      pregnant, obese women to increase and maintain activity during pregnancy. The feasibility&#xD;
      study will test the recruitment strategy, acceptability of the intervention design,&#xD;
      randomisation acceptability, and timing of the intervention. Participants from both the&#xD;
      control and the intervention will be purposefully selected to take part in focus group&#xD;
      following the intervention in order to give feedback on the study. The investigators will be&#xD;
      working with an Obstetrics &amp; Gynaecology consultant at Jessop Wing, Hallamshire Hospital to&#xD;
      help with the recruitment process and provide clinical advice. Women who are obese&#xD;
      (BMI&gt;30kg/m2) in their early pregnancy (12-14 weeks) will be recruited. Participants that&#xD;
      consent to take part in the study will be given a Fitbit pedometer and enrolled in a closed&#xD;
      Facebook group. Each participant will wear a Fitbit for a week in order to measure their&#xD;
      baseline physical activity level. Thereafter, the participants in the intervention will be&#xD;
      asked to gradually increase their physical activity level (they will be given a weekly step&#xD;
      target)for 4 weeks in total. The Facebook component of the intervention will contain&#xD;
      motivational and educational posts and rewarding messages about their progress. The control&#xD;
      group will be asked to wear a Fitbit for 5 weeks and do their usual activities in total with&#xD;
      a covered screen so as to not see the step count&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Feasibility Randomized Control Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>It is difficult to mask in these type of interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>5 weeks</time_frame>
    <description>Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>5 weeks</time_frame>
    <description>Compliance to the study procedures will be calculated by simple descriptive. statistics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition</measure>
    <time_frame>5 weeks</time_frame>
    <description>Drop out rate will be calculated by simple descriptive statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence rates</measure>
    <time_frame>5 weeks</time_frame>
    <description>Adherence to Fitbit will be measured daily.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational Weight Gain</measure>
    <time_frame>5 weeks</time_frame>
    <description>Women are recruited at 11-14 weeks gestation and after 5 weeks when they are at 20 weeks gestation the final assessments will be collected. Weight is measured in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gestational diabetes status</measure>
    <time_frame>26 weeks</time_frame>
    <description>Outcome of the gestational diabetes mellitus test at 26 weeks gestation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy and Birth outcomes</measure>
    <time_frame>9 months</time_frame>
    <description>Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-section</measure>
    <time_frame>9 months</time_frame>
    <description>Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>At delivery ( 9 months roughly)</time_frame>
    <description>Weight of the baby at birth. This data will be collected from clinical notes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar score</measure>
    <time_frame>At delivery ( 9 months roughly)</time_frame>
    <description>5 minute Apgar Score. Score data will be collected from clinical notes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Maternal Obesity Complicating Pregnancy</condition>
  <condition>Maternal Obesity Complicating Childbirth</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group received usual care plus a blinded Fitbit pedometer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>walking and behavour change techniques</intervention_name>
    <description>a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant 11-14 weeks gestation&#xD;
&#xD;
          -  BMI &gt;30kg/m2&#xD;
&#xD;
          -  No known risks or complications&#xD;
&#xD;
          -  Able to walk&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk of miscarriage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only women can be pregnant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Maternal</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03307733
org study id: STH19365
nct id: NCT03307733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A physical activity feasibility randomised control trial for pregnant, obese women.
Overweight (defined as BMI ≥25kg/m2) and obesity (defined as BMI ≥30kg/m2) during pregnancy
      is becoming more common. Approximately 25-30% of women of childbearing age are obese and
      around 50% are overweight at the time of conception. Women who are either overweight or obese
      have a much higher risk of adverse pregnancy outcomes. For example, they are more likely to
      develop gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, Caesarean
      section and other complications. Recent research suggests that overweight and obese pregnant
      women are less active than normal weight ( BMI≤ 25kg/m2) pregnant women and also that the
      level of physical activity decreases throughout pregnancy. The evidence also suggests that
      maintaining a good level of physical activity can reduce the risks of adverse pregnancy
      outcomes. A large study which looked at the most preferred types of physical activity
      identified that walking and swimming were the most preferred types of physical activity by
      pregnant women. Although there is an association between walking at a brisk pace and a
      reduced risk of gestational diabetes, there is no definitive conclusion on the effectiveness
      of walking interventions. The investigators are proposing this feasibility study in order to
      find out whether a walking intervention can be implemented during pregnancy in the obese
      population to reduce adverse pregnancy health outcomes. The current study will investigate
      whether a Fitibit Pedometer and a Social networking Site (Facebook) can be used to encourage
      pregnant, obese women to increase and maintain activity during pregnancy. The feasibility
      study will test the recruitment strategy, acceptability of the intervention design,
      randomisation acceptability, and timing of the intervention. Participants from both the
      control and the intervention will be purposefully selected to take part in focus group
      following the intervention in order to give feedback on the study. The investigators will be
      working with an Obstetrics & Gynaecology consultant at Jessop Wing, Hallamshire Hospital to
      help with the recruitment process and provide clinical advice. Women who are obese
      (BMI>30kg/m2) in their early pregnancy (12-14 weeks) will be recruited. Participants that
      consent to take part in the study will be given a Fitbit pedometer and enrolled in a closed
      Facebook group. Each participant will wear a Fitbit for a week in order to measure their
      baseline physical activity level. Thereafter, the participants in the intervention will be
      asked to gradually increase their physical activity level (they will be given a weekly step
      target)for 4 weeks in total. The Facebook component of the intervention will contain
      motivational and educational posts and rewarding messages about their progress. The control
      group will be asked to wear a Fitbit for 5 weeks and do their usual activities in total with
      a covered screen so as to not see the step count
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Feasibility Randomized Control Trial
primary purpose: Prevention
masking: None (Open Label)
masking description: It is difficult to mask in these type of interventions.
measure: Recruitment
time frame: 5 weeks
description: Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)
measure: Compliance
time frame: 5 weeks
description: Compliance to the study procedures will be calculated by simple descriptive. statistics
measure: Attrition
time frame: 5 weeks
description: Drop out rate will be calculated by simple descriptive statistics.
measure: Adherence rates
time frame: 5 weeks
description: Adherence to Fitbit will be measured daily.
measure: Gestational Weight Gain
time frame: 5 weeks
description: Women are recruited at 11-14 weeks gestation and after 5 weeks when they are at 20 weeks gestation the final assessments will be collected. Weight is measured in kilograms.
measure: gestational diabetes status
time frame: 26 weeks
description: Outcome of the gestational diabetes mellitus test at 26 weeks gestation.
measure: Pregnancy and Birth outcomes
time frame: 9 months
description: Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).
measure: C-section
time frame: 9 months
description: Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)
measure: Birth weight
time frame: At delivery ( 9 months roughly)
description: Weight of the baby at birth. This data will be collected from clinical notes.
measure: Apgar score
time frame: At delivery ( 9 months roughly)
description: 5 minute Apgar Score. Score data will be collected from clinical notes.
arm group label: Control Group
arm group type: No Intervention
description: Control group received usual care plus a blinded Fitbit pedometer.
arm group label: Intervention
arm group type: Active Comparator
description: Intervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group
intervention type: Behavioral
intervention name: walking and behavour change techniques
description: a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
gender description: only women can be pregnant
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Obesity, Maternal
mesh term: Pregnancy Complications
mesh term: Obesity
sharing ipd: Undecided