<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/NCT03758638</url>
  </required_header>
  <id_info>
    <org_study_id>201810157-1R01HL143360</org_study_id>
    <nct_id>NCT03758638</nct_id>
  </id_info>
  <brief_title>Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination &amp; Implementation (D&amp;I)</brief_title>
  <acronym>HEALTH D&amp;I</acronym>
  <official_title>Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to&#xD;
      prevent weight gain and promote weight loss when disseminated and implemented in real-world&#xD;
      settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also&#xD;
      evaluates implementation outcomes from the training curriculum (implementation strategy) and&#xD;
      external validity when HEALTH is implemented within this national home visiting organization.&#xD;
      This partnership has potential for significant impact on obesity and chronic diseases such as&#xD;
      cardiovascular disease and diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked&#xD;
      trend that must be addressed to reverse the epidemics of obesity and chronic disease. During&#xD;
      this vulnerable period women tend to gain disproportionally large amounts of weight compared&#xD;
      to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented&#xD;
      weight gain, promoted sustained weight loss, and reduced waist circumference was developed in&#xD;
      partnership with Parents as Teachers (PAT), a national home visiting, community based&#xD;
      organization with significant reach in this population. PAT provides parent-child education&#xD;
      and services free-of-charge to nearly 170,000 families through up to 25 free home visits per&#xD;
      year until the child enters kindergarten. This study will extend these findings with a&#xD;
      pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of&#xD;
      HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact.&#xD;
      The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH&#xD;
      training curriculum (implementation strategy) on weight among mothers with overweight and&#xD;
      obesity across the US (N= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing&#xD;
      PAT sites (20 HEALTH, 20 usual care) will receive the HEALTH training curriculum through the&#xD;
      PAT National Center, using PAT's existing training infrastructure, as a continuing education&#xD;
      opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption,&#xD;
      Implementation, and Maintenance) will determine implementation outcomes (acceptability,&#xD;
      adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator&#xD;
      level. The Conceptual Framework for Implementation research will characterize determinants&#xD;
      that influence HEALTH dissemination and implementation at three levels: mother, parent&#xD;
      educator, PAT site to enhance external validity (reach and maintenance) and population level&#xD;
      impact. The findings from this innovative study will have significant potential to help&#xD;
      reverse the trend of excessive weight gain among young adult women, a critical priority&#xD;
      target in battling the epidemics of obesity and chronic disease, by reaching women with an&#xD;
      evidence-based intervention nation-wide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 3</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>Healthy Eating &amp; Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>24-months</time_frame>
    <description>Mother's body weight assessed by data collector</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fidelity of delivery to the intervention</measure>
    <time_frame>throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized</time_frame>
    <description>Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">624</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Healthy Eating &amp; Active Living Taught at Home</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).&#xD;
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants at usual care PAT sites will receive PAT as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Eating &amp; Active Living Taught at Home</intervention_name>
    <description>PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.</description>
    <arm_group_label>Healthy Eating &amp; Active Living Taught at Home</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.</description>
    <arm_group_label>Usual Care</arm_group_label>
    <other_name>Parents as Teachers</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For Parent educators:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Deliver PAT at a site participating in the study&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
        For Participants:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years of age&#xD;
&#xD;
          -  overweight or obese (BMI 25-45 kg/m2)&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  participating or willing to participate in PAT at a participating PAT site for 2 years&#xD;
&#xD;
          -  able to give informed consent for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently pregnant or planning to become pregnant in the next 24 months&#xD;
&#xD;
          -  unable to speak English or Spanish&#xD;
&#xD;
          -  unable to engage in a walking program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>For the participants (i.e., not the parent educators), only women will be included: Including only female participants is scientifically justified, as the study focus is addressing the dramatic weight gain women experience in early adulthood, which is not experienced to the same extent among men. Further, HEALTH was tested and demonstrated effectiveness only in mothers, and the very small number of fathers who participate in PAT will not provide an adequate sample to evaluate HEALTH in this population.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel G Tabak, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel G Tabak, PhD, RD</last_name>
    <phone>3149350153</phone>
    <email>rtabak@wustl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cindy D Schwarz, MPH, MS, RD</last_name>
    <phone>314-935-3063</phone>
    <email>cschwarz@wustl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel G Tabak, PhD</last_name>
      <phone>314-935-0153</phone>
      <email>rtabak@wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Cindy Schwarz, MPH, MS, RD</last_name>
      <phone>314-935-3063</phone>
      <email>cschwarz@wustl.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Only data with identifiers removed will be shared publicly.&#xD;
Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution.&#xD;
Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.</ipd_description>
  </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/NCT03758638
org study id: 201810157-1R01HL143360
nct id: NCT03758638
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to
      prevent weight gain and promote weight loss when disseminated and implemented in real-world
      settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also
      evaluates implementation outcomes from the training curriculum (implementation strategy) and
      external validity when HEALTH is implemented within this national home visiting organization.
      This partnership has potential for significant impact on obesity and chronic diseases such as
      cardiovascular disease and diabetes.
Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked
      trend that must be addressed to reverse the epidemics of obesity and chronic disease. During
      this vulnerable period women tend to gain disproportionally large amounts of weight compared
      to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented
      weight gain, promoted sustained weight loss, and reduced waist circumference was developed in
      partnership with Parents as Teachers (PAT), a national home visiting, community based
      organization with significant reach in this population. PAT provides parent-child education
      and services free-of-charge to nearly 170,000 families through up to 25 free home visits per
      year until the child enters kindergarten. This study will extend these findings with a
      pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of
      HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact.
      The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH
      training curriculum (implementation strategy) on weight among mothers with overweight and
      obesity across the US (N= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing
      PAT sites (20 HEALTH, 20 usual care) will receive the HEALTH training curriculum through the
      PAT National Center, using PAT's existing training infrastructure, as a continuing education
      opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption,
      Implementation, and Maintenance) will determine implementation outcomes (acceptability,
      adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator
      level. The Conceptual Framework for Implementation research will characterize determinants
      that influence HEALTH dissemination and implementation at three levels: mother, parent
      educator, PAT site to enhance external validity (reach and maintenance) and population level
      impact. The findings from this innovative study will have significant potential to help
      reverse the trend of excessive weight gain among young adult women, a critical priority
      target in battling the epidemics of obesity and chronic disease, by reaching women with an
      evidence-based intervention nation-wide.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Healthy Eating & Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Weight
time frame: 24-months
description: Mother's body weight assessed by data collector
measure: Fidelity of delivery to the intervention
time frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
description: Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure
arm group label: Healthy Eating & Active Living Taught at Home
arm group type: Experimental
description: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
arm group label: Usual Care
arm group type: Active Comparator
description: Participants at usual care PAT sites will receive PAT as usual
intervention type: Behavioral
intervention name: Healthy Eating & Active Living Taught at Home
description: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
arm group label: Healthy Eating & Active Living Taught at Home
intervention type: Behavioral
intervention name: Usual Care
description: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
arm group label: Usual Care
other name: Parents as Teachers
criteria: 
gender: All
gender based: Yes
gender description: For the participants (i.e., not the parent educators), only women will be included: Including only female participants is scientifically justified, as the study focus is addressing the dramatic weight gain women experience in early adulthood, which is not experienced to the same extent among men. Further, HEALTH was tested and demonstrated effectiveness only in mothers, and the very small number of fathers who participate in PAT will not provide an adequate sample to evaluate HEALTH in this population.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel G Tabak, PhD, RD
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Rachel G Tabak, PhD, RD
phone: 3149350153
email: rtabak@wustl.edu
last name: Cindy D Schwarz, MPH, MS, RD
phone: 314-935-3063
email: cschwarz@wustl.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Only data with identifiers removed will be shared publicly.
Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution.
Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.