<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/NCT04414696</url>
  </required_header>
  <id_info>
    <org_study_id>1548855</org_study_id>
    <nct_id>NCT04414696</nct_id>
  </id_info>
  <brief_title>Postpartum Wellness</brief_title>
  <acronym>POW</acronym>
  <official_title>Preventing Postpartum Depression: Exercise as Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</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>
      The purpose of this study is to test whether a web-based (eHealth) exercise intervention for&#xD;
      new moms at increased risk for postpartum depression increases physical activity and&#xD;
      decreases postpartum depression symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postpartum depression is a debilitating and costly condition that is associated with&#xD;
      significant health consequences for mothers and children. Counseling for prevention of&#xD;
      postpartum depression is currently recommended in women at high risk of postpartum&#xD;
      depression; however, there is a shortage of mental health care providers. There is a need for&#xD;
      effective interventions to prevent postpartum depression that can be easily integrated into&#xD;
      health care systems, yet do not involve intense health care system resources. eHealth&#xD;
      interventions are promising in this regard.&#xD;
&#xD;
      Strong evidence suggests physical activity can reduce depression risk. This study will assess&#xD;
      the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for&#xD;
      increasing physical activity levels and improving depressive symptoms in women at increased&#xD;
      risk of postpartum depression. This intervention addresses several identified barriers to&#xD;
      physical activity in postpartum women. The study will randomize 200 women to receive an&#xD;
      eHealth exercise intervention for postpartum women or usual postpartum care. Device-based&#xD;
      physical activity and depressive symptoms will be measured at 3 and 6 months after&#xD;
      randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 19, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Single (Investigator)</masking>
    <masking_description>The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>0-3 months</time_frame>
    <description>Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8).&#xD;
PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>0-3 months</time_frame>
    <description>Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>0-3 months and 3-6 months</time_frame>
    <description>Self-report measured minutes of moderate/vigorous physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>3-6 months</time_frame>
    <description>Device-based (Actigraph-measured) minutes of moderate/vigorous physical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>3-6 months</time_frame>
    <description>Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8).&#xD;
PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep</measure>
    <time_frame>0-3 months and 3-6 months</time_frame>
    <description>Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).&#xD;
The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mother-infant bonding</measure>
    <time_frame>0-3 months and 3-6 months</time_frame>
    <description>The Mother Infant Bonding Scale by Taylor et al will be used to assess mother-infant bonding.&#xD;
Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>0-3 months and 3-6 months</time_frame>
    <description>The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety.&#xD;
GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress</measure>
    <time_frame>0-3 months and 3-6 months</time_frame>
    <description>Perceived stress will be measured using the Perceived Stress Scale (PSS-10).&#xD;
PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Infant development</measure>
    <time_frame>At 12 months old</time_frame>
    <description>Ages and Stages questionnaire for 12-month-old infants.&#xD;
The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise intervention</intervention_name>
    <description>eHealth exercise intervention for postpartum women at increased risk of depression</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  KPNC member between 2 and 6 months postpartum&#xD;
&#xD;
          -  Current PHQ-8 score between 10-20 and no current depression diagnosis&#xD;
&#xD;
          -  Delivered baby in KPNC&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Own a smartphone, computer, or TV with internet access&#xD;
&#xD;
          -  Free of a heart condition and a physician recommending medically supervised physical&#xD;
             activity&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18.5 and 40 (kg/m2)&#xD;
&#xD;
          -  A baby weighing between 11-22 lbs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Engaged in regular, moderate or vigorous physical activity &gt;90 minutes or more per&#xD;
             week&#xD;
&#xD;
          -  Pregnant or planning to become pregnant in the ensuing three months&#xD;
&#xD;
          -  A baby with chronic illness/disorder(s) that prevent participant from holding or&#xD;
             lifting him/her&#xD;
&#xD;
          -  Chest pain during physical activity, or has had chest pain within the prior month&#xD;
&#xD;
          -  Taking medication for hypertension or a heart condition&#xD;
&#xD;
          -  Tendency to fall due to syncope or dizziness&#xD;
&#xD;
          -  Orthopedic problems that might be aggravated by physical activity&#xD;
&#xD;
          -  Has exercise-induced asthma&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndsay Avalos, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Research</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Postpartum Depression</keyword>
  <keyword>Physical activity</keyword>
  <keyword>eHealth intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT04414696
org study id: 1548855
nct id: NCT04414696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test whether a web-based (eHealth) exercise intervention for
      new moms at increased risk for postpartum depression increases physical activity and
      decreases postpartum depression symptoms.
Postpartum depression is a debilitating and costly condition that is associated with
      significant health consequences for mothers and children. Counseling for prevention of
      postpartum depression is currently recommended in women at high risk of postpartum
      depression; however, there is a shortage of mental health care providers. There is a need for
      effective interventions to prevent postpartum depression that can be easily integrated into
      health care systems, yet do not involve intense health care system resources. eHealth
      interventions are promising in this regard.

      Strong evidence suggests physical activity can reduce depression risk. This study will assess
      the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for
      increasing physical activity levels and improving depressive symptoms in women at increased
      risk of postpartum depression. This intervention addresses several identified barriers to
      physical activity in postpartum women. The study will randomize 200 women to receive an
      eHealth exercise intervention for postpartum women or usual postpartum care. Device-based
      physical activity and depressive symptoms will be measured at 3 and 6 months after
      randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
masking description: The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
measure: Depression symptoms
time frame: 0-3 months
description: Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8).
PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
measure: Physical Activity
time frame: 0-3 months
description: Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity
measure: Physical Activity
time frame: 0-3 months and 3-6 months
description: Self-report measured minutes of moderate/vigorous physical activity
measure: Physical Activity
time frame: 3-6 months
description: Device-based (Actigraph-measured) minutes of moderate/vigorous physical
measure: Depressive symptoms
time frame: 3-6 months
description: Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8).
PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
measure: Sleep
time frame: 0-3 months and 3-6 months
description: Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.
measure: Mother-infant bonding
time frame: 0-3 months and 3-6 months
description: The Mother Infant Bonding Scale by Taylor et al will be used to assess mother-infant bonding.
Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.
measure: Anxiety
time frame: 0-3 months and 3-6 months
description: The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety.
GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
measure: Stress
time frame: 0-3 months and 3-6 months
description: Perceived stress will be measured using the Perceived Stress Scale (PSS-10).
PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.
measure: Infant development
time frame: At 12 months old
description: Ages and Stages questionnaire for 12-month-old infants.
The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
arm group label: Intervention
arm group type: Experimental
description: Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
arm group label: Usual Care
arm group type: No Intervention
description: Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
intervention type: Behavioral
intervention name: Exercise intervention
description: eHealth exercise intervention for postpartum women at increased risk of depression
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Lyndsay Avalos, PhD, MPH
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No