<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/NCT03028233</url>
  </required_header>
  <id_info>
    <org_study_id>H00005048</org_study_id>
    <secondary_id>U48DP005031</secondary_id>
    <nct_id>NCT03028233</nct_id>
  </id_info>
  <brief_title>Healthy Kids &amp; Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention</brief_title>
  <official_title>Healthy Kids &amp; Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oak Hill Community Development Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Worcester Public Schools</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Worcester</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 study will test the impact of a community health worker (CHW)-delivered intervention&#xD;
      aimed at helping families overcome barriers to childhood obesity prevention. Barriers include&#xD;
      social, environmental, and family issues.&#xD;
&#xD;
      This intervention will be compared to a control condition consisting of a community health&#xD;
      worker (CHW)-delivered intervention aimed at helping families improve positive parenting&#xD;
      skills.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will test the impact of a community health worker (CHW)-delivered intervention&#xD;
      aimed at helping families overcome barriers to childhood obesity prevention. Barriers include&#xD;
      social, environmental, and family issues.&#xD;
&#xD;
      This intervention will be compared to a control condition consisting of a community health&#xD;
      worker (CHW)-delivered intervention aimed at helping families improve positive parenting&#xD;
      skills.&#xD;
&#xD;
      The intervention uses multiple delivery modalities to maintain novelty and prevent&#xD;
      attrition/burden. These include home visits, telephone contacts, print (literacy sensitive&#xD;
      newsletters), social media (Facebook), and community events. Parents and children will&#xD;
      complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.&#xD;
&#xD;
      The Specific Aims are:&#xD;
&#xD;
      Aim 1: To determine the effectiveness of the intervention compared to the control condition&#xD;
      on child physical activity, healthy eating, BMI and utilization of built environment&#xD;
      resources.&#xD;
&#xD;
      Aim 2: To determine the effectiveness of the intervention compared to the control condition&#xD;
      on parent physical activity, healthy eating, BMI.&#xD;
&#xD;
      Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach&#xD;
      Effectiveness Adoption Implementation Maintenance) model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 22, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>child BMI z-score</measure>
    <time_frame>2 years</time_frame>
    <description>Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Dietary Behaviors: Overall</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Dietary Behaviors for snacks</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Dietary Behaviors for Beverages</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Dietary Behaviors: Overall</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Dietary Behaviors for Snacks</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Dietary Behaviors for Beverages</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Physical Activity and Sedentariness: C-PAQ and PAQ-C</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Physical Activity and Sedentariness: ActiGraph GT1M</measure>
    <time_frame>2 years</time_frame>
    <description>Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent physical activity and sedentariness: C-PAQ and PAQ-C</measure>
    <time_frame>2 years</time_frame>
    <description>This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent physical activity and sedentariness: ActiGraph GT1M</measure>
    <time_frame>2 years</time_frame>
    <description>Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent BMI</measure>
    <time_frame>2 years</time_frame>
    <description>BMI is calculated with weight and height measurements using standard methodology. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child utilization of built environment resources</measure>
    <time_frame>2 years</time_frame>
    <description>Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer. The GPS unit records the geographic coordinates of the child's activities. Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Healthy Lifestyles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Parenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Lifestyle</intervention_name>
    <description>A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.</description>
    <arm_group_label>Healthy Lifestyles</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Parenting</intervention_name>
    <description>A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.</description>
    <arm_group_label>Positive Parenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible individuals for the research study are parents/guardians and their K-6th&#xD;
             grade children attending one of 9 schools in the greater Worcester area. Parents and&#xD;
             their children are recruited as parent-child dyads.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has an inability or unwillingness to give informed consent or assent&#xD;
&#xD;
          -  Is a prisoner&#xD;
&#xD;
        Exclusion (child only)&#xD;
&#xD;
          -  The child has been told by a doctor that they cannot walk or eat fruits and&#xD;
             vegetables.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Milagros C Rosal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMass Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wenjun Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMass Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMass Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Milagros Rosal</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>healthy eating</keyword>
  <keyword>weight</keyword>
  <keyword>families</keyword>
  <keyword>Community Health Worker</keyword>
  <keyword>childhood obesity</keyword>
  <keyword>built environment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT03028233
org study id: H00005048
secondary id: U48DP005031
nct id: NCT03028233
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will test the impact of a community health worker (CHW)-delivered intervention
      aimed at helping families overcome barriers to childhood obesity prevention. Barriers include
      social, environmental, and family issues.

      This intervention will be compared to a control condition consisting of a community health
      worker (CHW)-delivered intervention aimed at helping families improve positive parenting
      skills.
The study will test the impact of a community health worker (CHW)-delivered intervention
      aimed at helping families overcome barriers to childhood obesity prevention. Barriers include
      social, environmental, and family issues.

      This intervention will be compared to a control condition consisting of a community health
      worker (CHW)-delivered intervention aimed at helping families improve positive parenting
      skills.

      The intervention uses multiple delivery modalities to maintain novelty and prevent
      attrition/burden. These include home visits, telephone contacts, print (literacy sensitive
      newsletters), social media (Facebook), and community events. Parents and children will
      complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.

      The Specific Aims are:

      Aim 1: To determine the effectiveness of the intervention compared to the control condition
      on child physical activity, healthy eating, BMI and utilization of built environment
      resources.

      Aim 2: To determine the effectiveness of the intervention compared to the control condition
      on parent physical activity, healthy eating, BMI.

      Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach
      Effectiveness Adoption Implementation Maintenance) model.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: child BMI z-score
time frame: 2 years
description: Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
measure: Child Dietary Behaviors: Overall
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
measure: Child Dietary Behaviors for snacks
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
measure: Child Dietary Behaviors for Beverages
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
measure: Parent Dietary Behaviors: Overall
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
measure: Parent Dietary Behaviors for Snacks
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
measure: Parent Dietary Behaviors for Beverages
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
measure: Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
measure: Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
measure: Child Physical Activity and Sedentariness: ActiGraph GT1M
time frame: 2 years
description: Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities.
measure: Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
measure: Parent physical activity and sedentariness: C-PAQ and PAQ-C
time frame: 2 years
description: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
measure: Parent physical activity and sedentariness: ActiGraph GT1M
time frame: 2 years
description: Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities
measure: Parent BMI
time frame: 2 years
description: BMI is calculated with weight and height measurements using standard methodology. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
measure: Child utilization of built environment resources
time frame: 2 years
description: Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer. The GPS unit records the geographic coordinates of the child's activities. Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
arm group label: Healthy Lifestyles
arm group type: Experimental
description: The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
arm group label: Positive Parenting
arm group type: Active Comparator
description: The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
intervention type: Behavioral
intervention name: Healthy Lifestyle
description: A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
arm group label: Healthy Lifestyles
intervention type: Behavioral
intervention name: Positive Parenting
description: A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
arm group label: Positive Parenting
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Milagros C Rosal, PhD
role: Principal Investigator
affiliation: UMass Medical School
last name: Wenjun Li, PhD
role: Principal Investigator
affiliation: UMass Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Milagros Rosal
investigator title: Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No