<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/NCT04414553</url>
  </required_header>
  <id_info>
    <org_study_id>20-1337</org_study_id>
    <nct_id>NCT04414553</nct_id>
  </id_info>
  <brief_title>Community Active and Healthy Families</brief_title>
  <acronym>CommunityAHF</acronym>
  <official_title>Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      To address childhood overweight disparities among Latino children in immigrant families a&#xD;
      pilot trial of a community-based obesity treatment program, Community Active and Healthy&#xD;
      Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant&#xD;
      families using pre/post design will be conducted.&#xD;
&#xD;
      The hypothesis is that children participating in Community-AHF will demonstrate a reduction&#xD;
      in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical&#xD;
      activity behaviors (secondary outcomes) at intervention completion compared with&#xD;
      pre-intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To address childhood overweight disparities among Latino children in immigrant families a&#xD;
      pilot trial of a community-based obesity treatment program, Community Active and Healthy&#xD;
      Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant&#xD;
      families using a pre/post design will be conducted.&#xD;
&#xD;
      As this is a pilot study, we will not be powered to detect statistically significant&#xD;
      differences pre- and post- intervention. We will measure the average change in %BMIp95&#xD;
      between baseline and completion of the Community-AHF active phase. Without a counterfactual&#xD;
      (control group) we will not be able assign responsibility to Community-AHF for any observed&#xD;
      improvements. Change in %BMIp95 across the study period will provide data to test our&#xD;
      hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and&#xD;
      post-intervention data is ideal for generating sample size estimates for a larger randomized&#xD;
      control trial in the same population.&#xD;
&#xD;
      We will conduct within-individual analyses for each outcome of interest. We will only analyze&#xD;
      participants who contribute pre and post measures in order to avoid biases that can occur&#xD;
      when analyses are conducted with all available data. For each outcome for which a participant&#xD;
      contributes pre and post measurements, we will calculate pre and post means, standard&#xD;
      deviations, differences in means and the p-value of the difference. We will conduct&#xD;
      preliminary analyses of outcomes according to subgroups defined by rate of attendance at&#xD;
      intervention sessions. If adequate data are available, we will explore the possibility of a&#xD;
      nonresponse analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 15, 2023</start_date>
  <completion_date type="Anticipated">March 2027</completion_date>
  <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre/Post</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in age- and sex-specific BMI expressed as percent of the 95th percentile (%BMIp95)</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Child Body Mass Index as calculated from child height and weight measurement to assess change from baseline to 10 month followup</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in %BMIp95 Trajectory</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Child %BMIp95 over time as measured at baseline, 4 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Child Diet</measure>
    <time_frame>Baseline,4 months</time_frame>
    <description>Child diet is measured using the Block Kids Food Screener or selected questions from the School Physical Activity Nutrition Project (only used if Block screener not approved by University Purchasing office as it is licensed). The Block Kids Food Screener is a 41-item food frequency questionnaire developed by NutritionQuest (Berkeley, California, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Physical Activity</measure>
    <time_frame>Baseline, 4months</time_frame>
    <description>parent-report of the number of days the child is physically active for 60 minutes during a typical week Range 0-7, Higher scores indicate a better outcome (more physical activity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parenting Self-Efficacy</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Change in 4 questions related to self efficacy Range10-60, Higher scores indicate a better outcome (more parenting self efficacy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parent Promotion of Physical Activity/Healthy Eating</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>selected questions from the School Physical Activity and Nutrition Project</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Obesogenic Food Availability in the Home</measure>
    <time_frame>Baseline,4 months</time_frame>
    <description>Availability of food in the home that contributes to obesity (high-fat foods, candy, processed meats) determined by home food inventory measure Range: 0-71; lower scores indicate a better outcome (less obesogenic food in the home)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parent Perceived Stress</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The 10-item Perceived Stress Score measures global perceived stress experienced across the past 30 days.&#xD;
Range: 0-40, lower scores indicate a better outcome (less stress)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Total-log activity counts</measure>
    <time_frame>Baseline, 4 months,</time_frame>
    <description>This is an accelerometer-derived measure on a subset of participants that characterizes volume of activity. It is calculated by taking the log of activity counts observed for each minute, adding 1, and then calculating an average value per day. The log transformation of total activity counts results in the improved sensitivity to lower volumes of activity. This measure can be helpful for populations that have low levels of activity and is a continuous measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Total Activity Counts</measure>
    <time_frame>Baseline, 4 months,</time_frame>
    <description>This is an accelerometer derived measure that characterizes general volume of physical activity. This is the most commonly used measure to understand accelerometer-derived activity during the day and is a continuous measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Active-to-sedentary transition probability</measure>
    <time_frame>Baseline, 4 months,</time_frame>
    <description>This is an accelerometer-derived measure that characterizes fragmentation of physical activity and depends on the frequency of transitioning from active to sedentary state. It is a complementary measure to volume of physical activity. This is a bounded measure between 0-1.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Community-AHF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive the Community Active and Healthy Families Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Active and Healthy Families</intervention_name>
    <description>Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.&#xD;
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.</description>
    <arm_group_label>Community-AHF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child age 5-12 years with Parent/Caregiver age of 18 or more years&#xD;
&#xD;
          -  Child BMI &gt;/= 85th percentile for age&#xD;
&#xD;
          -  Parent is foreign-born, self identifies as Latino/Hispanic and speaks Spanish&#xD;
&#xD;
          -  Parental commitment to participate in a 4-month intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child health condition that prevents diet modification or engaging in physical&#xD;
             activity&#xD;
&#xD;
          -  Child BMI &gt;40kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa R DeCamp, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa R DeCamp, MD, MSPH</last_name>
    <phone>13037246499</phone>
    <email>lisa.decamp@cuanschutz.edu</email>
  </overall_contact>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <ipd_description>Pending further study planning we will make this decision.</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/NCT04414553
org study id: 20-1337
nct id: NCT04414553
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To address childhood overweight disparities among Latino children in immigrant families a
      pilot trial of a community-based obesity treatment program, Community Active and Healthy
      Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant
      families using pre/post design will be conducted.

      The hypothesis is that children participating in Community-AHF will demonstrate a reduction
      in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical
      activity behaviors (secondary outcomes) at intervention completion compared with
      pre-intervention
To address childhood overweight disparities among Latino children in immigrant families a
      pilot trial of a community-based obesity treatment program, Community Active and Healthy
      Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant
      families using a pre/post design will be conducted.

      As this is a pilot study, we will not be powered to detect statistically significant
      differences pre- and post- intervention. We will measure the average change in %BMIp95
      between baseline and completion of the Community-AHF active phase. Without a counterfactual
      (control group) we will not be able assign responsibility to Community-AHF for any observed
      improvements. Change in %BMIp95 across the study period will provide data to test our
      hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and
      post-intervention data is ideal for generating sample size estimates for a larger randomized
      control trial in the same population.

      We will conduct within-individual analyses for each outcome of interest. We will only analyze
      participants who contribute pre and post measures in order to avoid biases that can occur
      when analyses are conducted with all available data. For each outcome for which a participant
      contributes pre and post measurements, we will calculate pre and post means, standard
      deviations, differences in means and the p-value of the difference. We will conduct
      preliminary analyses of outcomes according to subgroups defined by rate of attendance at
      intervention sessions. If adequate data are available, we will explore the possibility of a
      nonresponse analysis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre/Post
primary purpose: Treatment
masking: None (Open Label)
measure: Change in age- and sex-specific BMI expressed as percent of the 95th percentile (%BMIp95)
time frame: Baseline, 4 months
description: Child Body Mass Index as calculated from child height and weight measurement to assess change from baseline to 10 month followup
measure: Change in %BMIp95 Trajectory
time frame: Baseline, 4 months
description: Child %BMIp95 over time as measured at baseline, 4 months
measure: Change in Child Diet
time frame: Baseline,4 months
description: Child diet is measured using the Block Kids Food Screener or selected questions from the School Physical Activity Nutrition Project (only used if Block screener not approved by University Purchasing office as it is licensed). The Block Kids Food Screener is a 41-item food frequency questionnaire developed by NutritionQuest (Berkeley, California, USA).
measure: Change in Child Physical Activity
time frame: Baseline, 4months
description: parent-report of the number of days the child is physically active for 60 minutes during a typical week Range 0-7, Higher scores indicate a better outcome (more physical activity)
measure: Change in Parenting Self-Efficacy
time frame: Baseline, 4 months
description: Change in 4 questions related to self efficacy Range10-60, Higher scores indicate a better outcome (more parenting self efficacy)
measure: Change in Parent Promotion of Physical Activity/Healthy Eating
time frame: Baseline, 4 months
description: selected questions from the School Physical Activity and Nutrition Project
measure: Change in Obesogenic Food Availability in the Home
time frame: Baseline,4 months
description: Availability of food in the home that contributes to obesity (high-fat foods, candy, processed meats) determined by home food inventory measure Range: 0-71; lower scores indicate a better outcome (less obesogenic food in the home)
measure: Change in Parent Perceived Stress
time frame: Baseline, 4 months
description: The 10-item Perceived Stress Score measures global perceived stress experienced across the past 30 days.
Range: 0-40, lower scores indicate a better outcome (less stress)
measure: Change in Total-log activity counts
time frame: Baseline, 4 months,
description: This is an accelerometer-derived measure on a subset of participants that characterizes volume of activity. It is calculated by taking the log of activity counts observed for each minute, adding 1, and then calculating an average value per day. The log transformation of total activity counts results in the improved sensitivity to lower volumes of activity. This measure can be helpful for populations that have low levels of activity and is a continuous measure.
measure: Change in Total Activity Counts
time frame: Baseline, 4 months,
description: This is an accelerometer derived measure that characterizes general volume of physical activity. This is the most commonly used measure to understand accelerometer-derived activity during the day and is a continuous measure.
measure: Change in Active-to-sedentary transition probability
time frame: Baseline, 4 months,
description: This is an accelerometer-derived measure that characterizes fragmentation of physical activity and depends on the frequency of transitioning from active to sedentary state. It is a complementary measure to volume of physical activity. This is a bounded measure between 0-1.
arm group label: Community-AHF
arm group type: Experimental
description: Participants in this arm will receive the Community Active and Healthy Families Intervention
intervention type: Behavioral
intervention name: Community Active and Healthy Families
description: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
arm group label: Community-AHF
criteria: 
gender: All
minimum age: 5 Years
maximum age: 99 Years
healthy volunteers: No
last name: Lisa R DeCamp, MD, MSPH
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Lisa R DeCamp, MD, MSPH
phone: 13037246499
email: lisa.decamp@cuanschutz.edu
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No
ipd description: Pending further study planning we will make this decision.