<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/NCT03261492</url>
  </required_header>
  <id_info>
    <org_study_id>5U01MD010667</org_study_id>
    <nct_id>NCT03261492</nct_id>
  </id_info>
  <brief_title>Sustainability Via Active Garden Education</brief_title>
  <acronym>SAGE</acronym>
  <official_title>Partnering for PA in Early Childhood: Sustainability Via Active Garden Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</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>
      The goal of SAGE is to determine if a garden-based curriculum can increase physical activity&#xD;
      and improve nutrition in young children at early care and education centers (ECEC) throughout&#xD;
      Phoenix&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SAGE will be delivered over a four month period using a cluster randomized controlled trial&#xD;
      adapted crossover design, along with testing a sustainability action plan (SAP) at the&#xD;
      organizational level. In this study, the investigators will determine the efficacy of the&#xD;
      SAGE intervention on health in 3-4 year-old children. This study will pair match and&#xD;
      randomize 20 ECEC from neighborhoods with high proportions of Hispanic or Latino residents.&#xD;
      ECEC will receive either the SAGE intervention or the safety attention comparison. Then, ECEC&#xD;
      will cross over and receive the treatment that they did not receive to ensure that all ECEC&#xD;
      receive both curricula. The investigators will determine improvement in accelerometry&#xD;
      measured PA and sedentary behaviors, fruit and vegetable consumption and explore eating in&#xD;
      the absence of hunger compared to those in a child safety attention comparison. The&#xD;
      investigators will explore secondary impacts on parenting practices that promote PA and fruit&#xD;
      and vegetable consumption, home fruit and vegetable availability and improved household food&#xD;
      security. This study will explore the process of delivery of the SAGE intervention on&#xD;
      dimensions of reach, adoption, and implementation. This study will also develop, implement,&#xD;
      and evaluate a SAP in the SAGE arm to determine replicability and institutionalization&#xD;
      (sustainability) of the SAGE intervention and explore the relationship between of&#xD;
      sustainability to child outcomes at follow-up. The development and success of the community&#xD;
      Partnership and SAGE Community Advisory Board will also be evaluated using indicators of&#xD;
      participation, representativeness, and collaboration. This study will rely on CBPR strategies&#xD;
      and an established theoretical model to implement an engaging and translational multilevel&#xD;
      intervention linking policy and practice. This work will test strategies for implementing IOM&#xD;
      guidelines at the ECE level and will guide future efforts aimed at scaling up efficacious&#xD;
      interventions for broad dissemination in vulnerable populations to reduce health disparities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The investigators will identify, recruit, and randomize ECEC to the SAGE intervention or a child safety attention comparison. After 16 weeks, intervention and comparison will cross over, allowing us to continue to investigate longitudinal and carry over effects. One ECEC of each pair will be randomized to the SAGE intervention and the other to the child safety attention comparison. ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curriculums.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change physical activity; sedentary time</measure>
    <time_frame>Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months</time_frame>
    <description>Assessed by ActiGraph accelerometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fruit and vegetable consumption</measure>
    <time_frame>Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months</time_frame>
    <description>24 hr diet recalls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on parenting practices in physical activity (PA)</measure>
    <time_frame>Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months</time_frame>
    <description>Assessed by physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on improved home fruit and vegetable availability</measure>
    <time_frame>Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months</time_frame>
    <description>Assessed by completing Home Food Inventory questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on parenting practices in fruits and vegetables</measure>
    <time_frame>Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months</time_frame>
    <description>Assessed by fruit and vegetable pactices questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1275</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAGE curriculum is a garden-based PA and nutrition educational program and presently includes 12 lessons that can be delivered once or twice a week. The SAGE garden-based curriculum includes active games and discussion as well as activities that include watering the ECEC garden.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child Safety Attention Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest. The curriculum will include concepts and lessons for educating young children on fire, pedestrian, water, household, neighborhood and playground safety. The curriculum includes handouts, coloring sheets, comic books, games, and songs that can be implemented with minimal training and preparation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.</description>
    <arm_group_label>Physical Activity</arm_group_label>
    <other_name>SAGE Garden Based Curriculum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child Safety Attention Comparison</intervention_name>
    <description>The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).</description>
    <arm_group_label>Child Safety Attention Comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        ECEC Inclusion Criteria:&#xD;
&#xD;
          -  Census tracts with &gt;30% Hispanic-Latino population&#xD;
&#xD;
          -  ECEC must be licensed and enroll at least 35 children aged 3-4 years old&#xD;
&#xD;
          -  Space for garden install&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not participating in CACFP&#xD;
&#xD;
          -  No space for a garden&#xD;
&#xD;
          -  Less than 35 children aged 3-5 years old enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca E Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>April 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03261492
org study id: 5U01MD010667
nct id: NCT03261492
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of SAGE is to determine if a garden-based curriculum can increase physical activity
      and improve nutrition in young children at early care and education centers (ECEC) throughout
      Phoenix
SAGE will be delivered over a four month period using a cluster randomized controlled trial
      adapted crossover design, along with testing a sustainability action plan (SAP) at the
      organizational level. In this study, the investigators will determine the efficacy of the
      SAGE intervention on health in 3-4 year-old children. This study will pair match and
      randomize 20 ECEC from neighborhoods with high proportions of Hispanic or Latino residents.
      ECEC will receive either the SAGE intervention or the safety attention comparison. Then, ECEC
      will cross over and receive the treatment that they did not receive to ensure that all ECEC
      receive both curricula. The investigators will determine improvement in accelerometry
      measured PA and sedentary behaviors, fruit and vegetable consumption and explore eating in
      the absence of hunger compared to those in a child safety attention comparison. The
      investigators will explore secondary impacts on parenting practices that promote PA and fruit
      and vegetable consumption, home fruit and vegetable availability and improved household food
      security. This study will explore the process of delivery of the SAGE intervention on
      dimensions of reach, adoption, and implementation. This study will also develop, implement,
      and evaluate a SAP in the SAGE arm to determine replicability and institutionalization
      (sustainability) of the SAGE intervention and explore the relationship between of
      sustainability to child outcomes at follow-up. The development and success of the community
      Partnership and SAGE Community Advisory Board will also be evaluated using indicators of
      participation, representativeness, and collaboration. This study will rely on CBPR strategies
      and an established theoretical model to implement an engaging and translational multilevel
      intervention linking policy and practice. This work will test strategies for implementing IOM
      guidelines at the ECE level and will guide future efforts aimed at scaling up efficacious
      interventions for broad dissemination in vulnerable populations to reduce health disparities.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The investigators will identify, recruit, and randomize ECEC to the SAGE intervention or a child safety attention comparison. After 16 weeks, intervention and comparison will cross over, allowing us to continue to investigate longitudinal and carry over effects. One ECEC of each pair will be randomized to the SAGE intervention and the other to the child safety attention comparison. ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curriculums.
primary purpose: Prevention
masking: None (Open Label)
measure: Change physical activity; sedentary time
time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
description: Assessed by ActiGraph accelerometers
measure: fruit and vegetable consumption
time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
description: 24 hr diet recalls
measure: Impact on parenting practices in physical activity (PA)
time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
description: Assessed by physical activity
measure: Impact on improved home fruit and vegetable availability
time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
description: Assessed by completing Home Food Inventory questionnaire
measure: Impact on parenting practices in fruits and vegetables
time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
description: Assessed by fruit and vegetable pactices questionnaire
arm group label: Physical Activity
arm group type: Experimental
description: SAGE curriculum is a garden-based PA and nutrition educational program and presently includes 12 lessons that can be delivered once or twice a week. The SAGE garden-based curriculum includes active games and discussion as well as activities that include watering the ECEC garden.
arm group label: Child Safety Attention Comparison
arm group type: Active Comparator
description: The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest. The curriculum will include concepts and lessons for educating young children on fire, pedestrian, water, household, neighborhood and playground safety. The curriculum includes handouts, coloring sheets, comic books, games, and songs that can be implemented with minimal training and preparation.
intervention type: Behavioral
intervention name: Physical Activity
description: SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
arm group label: Physical Activity
other name: SAGE Garden Based Curriculum
intervention type: Behavioral
intervention name: Child Safety Attention Comparison
description: The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).
arm group label: Child Safety Attention Comparison
criteria: 
gender: All
minimum age: 3 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca E Lee, PhD
role: Principal Investigator
affiliation: Arizona State University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No