<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/NCT04480931</url>
  </required_header>
  <id_info>
    <org_study_id>20-257</org_study_id>
    <nct_id>NCT04480931</nct_id>
  </id_info>
  <brief_title>Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women</brief_title>
  <official_title>Pilot Testing of a Mobile Health Intervention Designed to Increase Physical Activity and Improve Morbidity and Mortality-related Outcomes Among Pregnant and Postpartum Women in a Rural Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Kentucky University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Kentucky 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>
      The goal of this pilot project is to test the feasibility and potential efficacy of the&#xD;
      evidence-based mHealth app (BumptUp) for improving physical activity and subsequent health&#xD;
      outcomes (i.e. obesity, hypertension, insulin resistance) among pregnant and postpartum women&#xD;
      in a rural community.&#xD;
&#xD;
      In order to accomplish this goal, feasibility of the intervention protocol will be tested by&#xD;
      the assessment of recruitment (how many participants eligible per month), retention (% of&#xD;
      women who complete the study protocol), adherence to intervention (% of women who utilize the&#xD;
      app), and acceptability (survey and one-on-one exit interviews) during pregnancy and&#xD;
      postpartum.&#xD;
&#xD;
      Potential efficacy will be determined by examining trends in data on physical activity levels&#xD;
      (achieving the goal of 150 minutes per week of physical activity (surveys and accelerometry))&#xD;
      between groups. Other secondary outcomes will also be assessed: weight status, body&#xD;
      composition, blood pressure, insulin resistance, fitness levels, mental health, and infant&#xD;
      anthropometrics.&#xD;
&#xD;
      Clinical hypotheses:&#xD;
&#xD;
        1. The mHealth program will be feasible as evidenced by high rates of enrollment,&#xD;
           retention, and adherence, moderate-to-high levels of satisfaction, and low participant&#xD;
           burden.&#xD;
&#xD;
        2. The mHealth intervention will show promise towards improving physical activity levels&#xD;
           and other secondary outcomes in pregnant and postpartum women in a rural community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After contact is established and eligibility confirmed, Participants (N=40) will be enrolled&#xD;
      and baseline surveys will be conducted to collect information about lifestyle, mental health,&#xD;
      and anxiety levels. Patient data for those participants who have agreed to be in the study&#xD;
      and have specifically agreed on the consent form to allow the study team to pull data from&#xD;
      their prenatal charts. The data being pulled from charts will include patient weights, vital&#xD;
      signs, blood pressures, current complications, blood analytes, and glucose tolerance test&#xD;
      results from each prenatal visit. After the baby is born, delivery reports will also be&#xD;
      obtained in order to collect information on the delivery outcomes (gender, mode of delivery,&#xD;
      complications, time in labor) and baby's anthropometric data (birthweight, birth length, head&#xD;
      circumference).&#xD;
&#xD;
      Compensation will be in the form of Amazon gift cards (delivered electronically). There will&#xD;
      be 4 time points where they take the online assessments. At each time point, they will also&#xD;
      be mailed an Actigraph accelerometer to wear for one week. These will be sanitized and mailed&#xD;
      or dropped off to avoid any contamination from the study team to participants. When the week&#xD;
      is over, the study team will check in with participants and discuss a plan for pick up. They&#xD;
      can leave outside for a study team member to pick up (contactless ) or they can mail it back&#xD;
      (with provided return envelope).&#xD;
&#xD;
      Each participant will still receive a total of $160. They be recruited and consented online&#xD;
      around 18-20 weeks. Assessments will occur at 4 timepoints: baseline assessments at 23-25&#xD;
      weeks gestation ($40), phone check at 30 weeks, second assessment/set of surveys at 35-37&#xD;
      weeks ($40), delivery outcomes obtained, 6 week postpartum surveys ($40), and 12 week&#xD;
      postpartum surveys ($40).&#xD;
&#xD;
      Statistical Analyses:&#xD;
&#xD;
      Sample Size Determination: Sample size for this pilot study was determined based on&#xD;
      previously performed physical activity interventions among pregnant women. The effect size&#xD;
      (0.91) for the main outcome of physical activity was determined from looking at&#xD;
      post-intervention physical activity data from Asci et al.83. With this effect size, it was&#xD;
      determined using SAS software with a type I error rate of 0.05 that a sample size of 20 per&#xD;
      group could detect this difference with 80% power, thus our sample size of 15 per group is&#xD;
      justified for a pilot project.&#xD;
&#xD;
      Data Analyses:&#xD;
&#xD;
      Aim 1: To estimate the success and feasibility of recruitment methods, the number of people&#xD;
      who will hear about the study via various methods (e.g. health care providers, health fairs,&#xD;
      word-of-mouth) will be estimated. Then, the number of women who completed initial screening,&#xD;
      the number of women who meet the eligibility criteria, the number of women who complete each&#xD;
      of the assessments, the number of women randomized, and the number of women who adhere to the&#xD;
      intervention will be determined. The exit interview data will be analyzed via standard&#xD;
      content analyses for qualitative studies as previously described84 (and recently performed by&#xD;
      our group). Aim 2: Although the investigators may not detect all between group differences&#xD;
      because the investigators are proposing a pilot project, appropriate statistical tests will&#xD;
      be performed in order to examine trends, and thus, promise for effect in the larger future&#xD;
      trial. Normality of the distribution for each variable will be tested using&#xD;
      Kolmogorov-Smirnov tests, and non-normally distributed data will be transformed as needed.&#xD;
      The baseline characteristics of the two groups will be compared using t-tests or Chi square&#xD;
      tests. The potential effect of the intervention on study outcomes will be explored using&#xD;
      repeated measures ANOVAs (group x time). Specifically, physical activity data between groups&#xD;
      will be compared from pre-post intervention. All data will be entered in Redcap data&#xD;
      management system. Analyses will be conducted using SAS or other statistical software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2021</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>Pregnant women will be recruited ~20 weeks pregnant and after baseline assessments, randomized into the control or intervention group. The intervention group will utilize the mhealth intervention, while the control group will receive basic educational materials only.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The participant (as well as the study team and the health care provider) will know after randomization whether or not they are being provided access to the mobile app.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment feasibility during pregnancy</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>how many participants eligible and successfully recruited per month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol retention</measure>
    <time_frame>12 weeks postpartum</time_frame>
    <description>% of women who complete the study protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to intervention</measure>
    <time_frame>Pregnancy (35-37 weeks pregnant)</time_frame>
    <description>% of women who use the app daily</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to intervention</measure>
    <time_frame>Postpartum (12 weeks after delivery)</time_frame>
    <description>% of women who use the app daily</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>Postpartum (12 weeks after delivery)</time_frame>
    <description>measured via exit interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Postpartum (12 weeks)</time_frame>
    <description>Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Postpartum (6 weeks)</time_frame>
    <description>Assess the potential efficacy of the intervention by examining physical activity levels through Exercise Vital Sign Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal weight status</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>Body weight (lbs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight status</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Body weight (lbs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight status</measure>
    <time_frame>Postpartum (12 weeks post-delivery)</time_frame>
    <description>Body weight (lbs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal blood pressure</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>Assessed by nurse at clinical visit using standardized clinical equipment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal blood pressure</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Assessed by nurse at clinical visit using standardized clinical equipment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal blood pressure</measure>
    <time_frame>Postpartum (6 weeks post-delivery)</time_frame>
    <description>Assessed by nurse at clinical using standardized clinical equipment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal insulin resistance</measure>
    <time_frame>Pregnancy (24-29 weeks gestation)</time_frame>
    <description>Oral Glucose Tolerance Test Results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal endothelial dysfunction</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Assessed with a rapid, non-invasive technique that records endothelium-mediated changes in the peripheral arterial tone signal via a pair of finger probes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal postpartum depression</measure>
    <time_frame>Postpartum (12 weeks post-delivery)</time_frame>
    <description>Edinburgh postpartum depression survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mood</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>Profile of Mood Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mood</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Profile of Mood Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mood</measure>
    <time_frame>Postpartum (6 weeks post-delivery)</time_frame>
    <description>Profile of Mood Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mood</measure>
    <time_frame>Postpartum (12 weeks post-delivery)</time_frame>
    <description>Profile of Mood Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Pregnancy (23-25 weeks gestation)</time_frame>
    <description>Center for Epidemiological Studies Depression Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Pregnancy (35-37 weeks gestation)</time_frame>
    <description>Center for Epidemiological Studies Depression Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Postpartum (6 weeks post-delivery)</time_frame>
    <description>Center for Epidemiological Studies Depression Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Postpartum (12 weeks post-delivery)</time_frame>
    <description>Center for Epidemiological Studies Depression Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant birthweight</measure>
    <time_frame>At time of delivery</time_frame>
    <description>Collected at delivery by trained nursing staff</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Pregnancy</condition>
  <condition>Postpartum</condition>
  <arm_group>
    <arm_group_label>mHealth Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be provided with the mobile health app (including introductory videos on how to use its features).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will receive an educational brochure about physical activity during pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mHealth Intervention Group</intervention_name>
    <description>Access to the mobile health application with exercise plans and education</description>
    <arm_group_label>mHealth Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Brochure</intervention_name>
    <description>An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Age 18-44&#xD;
&#xD;
          -  2) Confirmed singleton viable pregnancy&#xD;
&#xD;
          -  3) English-Speaking (the app is currently only available in English)&#xD;
&#xD;
          -  4) Physician release to participate in exercise&#xD;
&#xD;
          -  5) Ownership of a smart phone&#xD;
&#xD;
          -  6) Plans to deliver at The Medical Center in Bowling Green, KY.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Multiple gestation pregnancy&#xD;
&#xD;
          -  2) Inability to provide voluntary informed consent&#xD;
&#xD;
          -  3) Any medical condition (pregnancy-related or not) that would preclude exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Kentucky University</name>
      <address>
        <city>Bowling Green</city>
        <state>Kentucky</state>
        <zip>42101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Kentucky University</investigator_affiliation>
    <investigator_full_name>Rachel Tinius</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <keyword>mobile health</keyword>
  <keyword>intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04480931
org study id: 20-257
nct id: NCT04480931
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this pilot project is to test the feasibility and potential efficacy of the
      evidence-based mHealth app (BumptUp) for improving physical activity and subsequent health
      outcomes (i.e. obesity, hypertension, insulin resistance) among pregnant and postpartum women
      in a rural community.

      In order to accomplish this goal, feasibility of the intervention protocol will be tested by
      the assessment of recruitment (how many participants eligible per month), retention (% of
      women who complete the study protocol), adherence to intervention (% of women who utilize the
      app), and acceptability (survey and one-on-one exit interviews) during pregnancy and
      postpartum.

      Potential efficacy will be determined by examining trends in data on physical activity levels
      (achieving the goal of 150 minutes per week of physical activity (surveys and accelerometry))
      between groups. Other secondary outcomes will also be assessed: weight status, body
      composition, blood pressure, insulin resistance, fitness levels, mental health, and infant
      anthropometrics.

      Clinical hypotheses:

        1. The mHealth program will be feasible as evidenced by high rates of enrollment,
           retention, and adherence, moderate-to-high levels of satisfaction, and low participant
           burden.

        2. The mHealth intervention will show promise towards improving physical activity levels
           and other secondary outcomes in pregnant and postpartum women in a rural community.
After contact is established and eligibility confirmed, Participants (N=40) will be enrolled
      and baseline surveys will be conducted to collect information about lifestyle, mental health,
      and anxiety levels. Patient data for those participants who have agreed to be in the study
      and have specifically agreed on the consent form to allow the study team to pull data from
      their prenatal charts. The data being pulled from charts will include patient weights, vital
      signs, blood pressures, current complications, blood analytes, and glucose tolerance test
      results from each prenatal visit. After the baby is born, delivery reports will also be
      obtained in order to collect information on the delivery outcomes (gender, mode of delivery,
      complications, time in labor) and baby's anthropometric data (birthweight, birth length, head
      circumference).

      Compensation will be in the form of Amazon gift cards (delivered electronically). There will
      be 4 time points where they take the online assessments. At each time point, they will also
      be mailed an Actigraph accelerometer to wear for one week. These will be sanitized and mailed
      or dropped off to avoid any contamination from the study team to participants. When the week
      is over, the study team will check in with participants and discuss a plan for pick up. They
      can leave outside for a study team member to pick up (contactless ) or they can mail it back
      (with provided return envelope).

      Each participant will still receive a total of $160. They be recruited and consented online
      around 18-20 weeks. Assessments will occur at 4 timepoints: baseline assessments at 23-25
      weeks gestation ($40), phone check at 30 weeks, second assessment/set of surveys at 35-37
      weeks ($40), delivery outcomes obtained, 6 week postpartum surveys ($40), and 12 week
      postpartum surveys ($40).

      Statistical Analyses:

      Sample Size Determination: Sample size for this pilot study was determined based on
      previously performed physical activity interventions among pregnant women. The effect size
      (0.91) for the main outcome of physical activity was determined from looking at
      post-intervention physical activity data from Asci et al.83. With this effect size, it was
      determined using SAS software with a type I error rate of 0.05 that a sample size of 20 per
      group could detect this difference with 80% power, thus our sample size of 15 per group is
      justified for a pilot project.

      Data Analyses:

      Aim 1: To estimate the success and feasibility of recruitment methods, the number of people
      who will hear about the study via various methods (e.g. health care providers, health fairs,
      word-of-mouth) will be estimated. Then, the number of women who completed initial screening,
      the number of women who meet the eligibility criteria, the number of women who complete each
      of the assessments, the number of women randomized, and the number of women who adhere to the
      intervention will be determined. The exit interview data will be analyzed via standard
      content analyses for qualitative studies as previously described84 (and recently performed by
      our group). Aim 2: Although the investigators may not detect all between group differences
      because the investigators are proposing a pilot project, appropriate statistical tests will
      be performed in order to examine trends, and thus, promise for effect in the larger future
      trial. Normality of the distribution for each variable will be tested using
      Kolmogorov-Smirnov tests, and non-normally distributed data will be transformed as needed.
      The baseline characteristics of the two groups will be compared using t-tests or Chi square
      tests. The potential effect of the intervention on study outcomes will be explored using
      repeated measures ANOVAs (group x time). Specifically, physical activity data between groups
      will be compared from pre-post intervention. All data will be entered in Redcap data
      management system. Analyses will be conducted using SAS or other statistical software.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pregnant women will be recruited ~20 weeks pregnant and after baseline assessments, randomized into the control or intervention group. The intervention group will utilize the mhealth intervention, while the control group will receive basic educational materials only.
primary purpose: Prevention
masking: None (Open Label)
masking description: The participant (as well as the study team and the health care provider) will know after randomization whether or not they are being provided access to the mobile app.
measure: Recruitment feasibility during pregnancy
time frame: Pregnancy (23-25 weeks gestation)
description: how many participants eligible and successfully recruited per month
measure: Protocol retention
time frame: 12 weeks postpartum
description: % of women who complete the study protocol
measure: Adherence to intervention
time frame: Pregnancy (35-37 weeks pregnant)
description: % of women who use the app daily
measure: Adherence to intervention
time frame: Postpartum (12 weeks after delivery)
description: % of women who use the app daily
measure: Acceptability of Intervention
time frame: Postpartum (12 weeks after delivery)
description: measured via exit interviews
measure: Physical activity levels
time frame: Pregnancy (23-25 weeks gestation)
description: Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data
measure: Physical activity levels
time frame: Pregnancy (35-37 weeks gestation)
description: Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data
measure: Physical activity levels
time frame: Postpartum (12 weeks)
description: Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data
measure: Physical activity levels
time frame: Postpartum (6 weeks)
description: Assess the potential efficacy of the intervention by examining physical activity levels through Exercise Vital Sign Survey
measure: Maternal weight status
time frame: Pregnancy (23-25 weeks gestation)
description: Body weight (lbs)
measure: Maternal weight status
time frame: Pregnancy (35-37 weeks gestation)
description: Body weight (lbs)
measure: Maternal weight status
time frame: Postpartum (12 weeks post-delivery)
description: Body weight (lbs)
measure: Maternal blood pressure
time frame: Pregnancy (23-25 weeks gestation)
description: Assessed by nurse at clinical visit using standardized clinical equipment
measure: Maternal blood pressure
time frame: Pregnancy (35-37 weeks gestation)
description: Assessed by nurse at clinical visit using standardized clinical equipment
measure: Maternal blood pressure
time frame: Postpartum (6 weeks post-delivery)
description: Assessed by nurse at clinical using standardized clinical equipment
measure: Maternal insulin resistance
time frame: Pregnancy (24-29 weeks gestation)
description: Oral Glucose Tolerance Test Results
measure: Maternal endothelial dysfunction
time frame: Pregnancy (35-37 weeks gestation)
description: Assessed with a rapid, non-invasive technique that records endothelium-mediated changes in the peripheral arterial tone signal via a pair of finger probes
measure: Maternal postpartum depression
time frame: Postpartum (12 weeks post-delivery)
description: Edinburgh postpartum depression survey
measure: Maternal mood
time frame: Pregnancy (23-25 weeks gestation)
description: Profile of Mood Survey
measure: Maternal mood
time frame: Pregnancy (35-37 weeks gestation)
description: Profile of Mood Survey
measure: Maternal mood
time frame: Postpartum (6 weeks post-delivery)
description: Profile of Mood Survey
measure: Maternal mood
time frame: Postpartum (12 weeks post-delivery)
description: Profile of Mood Survey
measure: Mental Health
time frame: Pregnancy (23-25 weeks gestation)
description: Center for Epidemiological Studies Depression Survey
measure: Mental Health
time frame: Pregnancy (35-37 weeks gestation)
description: Center for Epidemiological Studies Depression Survey
measure: Mental Health
time frame: Postpartum (6 weeks post-delivery)
description: Center for Epidemiological Studies Depression Survey
measure: Mental Health
time frame: Postpartum (12 weeks post-delivery)
description: Center for Epidemiological Studies Depression Survey
measure: Infant birthweight
time frame: At time of delivery
description: Collected at delivery by trained nursing staff
arm group label: mHealth Intervention Group
arm group type: Experimental
description: This group will be provided with the mobile health app (including introductory videos on how to use its features).
arm group label: Control Group
arm group type: Sham Comparator
description: This group will receive an educational brochure about physical activity during pregnancy.
intervention type: Behavioral
intervention name: mHealth Intervention Group
description: Access to the mobile health application with exercise plans and education
arm group label: mHealth Intervention Group
intervention type: Behavioral
intervention name: Educational Brochure
description: An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
arm group label: Control Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Western Kentucky University
investigator full name: Rachel Tinius
investigator title: Assistant Professor
sharing ipd: No
submitted: January 5, 2023