<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/NCT03781856</url>
  </required_header>
  <id_info>
    <org_study_id>1710977008</org_study_id>
    <nct_id>NCT03781856</nct_id>
  </id_info>
  <brief_title>La Vida Buena Childhood Obesity Program</brief_title>
  <official_title>La Vida Buena (The Good Life) Evaluation: A Quasi Experimental Intervention of a Community Health Worker Led Family-based Childhood Obesity Program for Hispanic Children 5-8 Years of Age on the US-Mexico Border</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mariposa Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</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>
      Mariposa Community Health Center, a health center in Nogales, Arizona on the US-Mexico&#xD;
      border, will provide a program to prevent obesity in children and create a community&#xD;
      environment that supports a healthy lifestyle. Mariposa designed and implemented the La Vida&#xD;
      Buena (&quot;The Good Life&quot;) program and already know that helps families eat more healthily and&#xD;
      exercise. Mariposa Community Health Center will test this program on younger children aged&#xD;
      5-8 years old. Providers will refer children who are overweight or obese to the La Vida Buena&#xD;
      Program. In order to determine if the La Vida Buena program works, Mariposa Community Health&#xD;
      center will implement the 8-week program with 100 overweight or obese children in their&#xD;
      Nogales clinic. They will measure their weight (BMI), exercise levels and food habits at the&#xD;
      beginning of the program and then 3- months and 6-months after the program ends. Mariposa&#xD;
      will compare these results to children in the nearby Rio Rico clinic who do not receive the&#xD;
      La Vida Buena program. These 100 overweight or obese children in Rio Rico will instead&#xD;
      receive one educational session, and the same information will be collected regarding BMI,&#xD;
      exercise level and food habits. After the 6-month period, the children from Rio Rico will be&#xD;
      able to receive the full La Vida Buena program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      La Vida Buena is a Mariposa project to educate children and families about healthy eating and&#xD;
      exercise habits. The Health providers at Mariposa Nogales and Rio Rico clinics will refer&#xD;
      children between 5-8 years old who are overweight or obese and their parents. Each child must&#xD;
      participate with a parent or adult caregiver who is at least 18 years old. Before the program&#xD;
      begins, the participant will attend an informational consent/registration session where they&#xD;
      will be asked to sign a consent form for themselves and their child if they want to&#xD;
      participate. The study will ask for certain information from each participant in order to&#xD;
      determine if the program is working. Each family will respond to a questionnaire at three&#xD;
      points: at the beginning of the program, three months after beginning the program, and six&#xD;
      months after beginning the program, for a total of six months.&#xD;
&#xD;
      The questionnaire will include questions about fruit, vegetable and carbohydrate consumption,&#xD;
      family behavior and habits regarding eating and exercise, moderate and vigorous physical&#xD;
      activity, sedentary behavior, local foods and environment factors that impact the family. In&#xD;
      addition, the child's weight will be measured at each time point.&#xD;
&#xD;
      Participation in La Vida Buena will take 6 months. At the Nogales site, participants will be&#xD;
      invited to a series of weekly classes over the course of 8 weeks that are being offered by&#xD;
      the Mariposa clinic related to child healthy weight, exercise and nutrition. At the Rio Rico&#xD;
      site, participants will be offered one face to face educational session about child healthy&#xD;
      weight with Mariposa staff. Participants will be scheduled for BMI measurements and&#xD;
      questionnaires three months after initiating the program, as well as six months after&#xD;
      initiating the La Vida Buena Program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>BMI</measure>
    <time_frame>baseline to 6 months follow up</time_frame>
    <description>Weight and height measured at baseline, post intervention and 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>baseline to 6 months follow up</time_frame>
    <description>Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fruit and vegetable consumption</measure>
    <time_frame>baseline to 6 months follow up</time_frame>
    <description>As measured by self reported servings per day or week with higher values considered to be a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple carbohydrate consumption</measure>
    <time_frame>baseline to 6 months follow up</time_frame>
    <description>As measured by self report servings per day or week with lower values considered to be a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family healthy habits</measure>
    <time_frame>baseline to 6 months follow up</time_frame>
    <description>As measured by the Family Nutrition and Physical Activity Tool designed to capture healthy family habits. The adapted scale includes 16 items that are score from 1 to 4 that measure physical activity, sport participation, television viewing and video games for their negative influence on child hood obesity. Total score ranges from 16 to 64 points, with an increased score being associated with positive outcomes. There is not threshold or cutoff for the scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>La Vida Buena Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered in a group setting over the course of 8 weeks in a community setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief educational session</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered one on one or in a group setting in a one-hour session at the clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>La Vida Buena Program</intervention_name>
    <description>The intervention is series of interactive one hour weekly classes over the course of 8 weeks related to child healthy weight, exercise and nutrition. Facilitated by community health workers, the classes are interactive and play-based and designed to engage both the child and accompanying parent or guardian in activities.</description>
    <arm_group_label>La Vida Buena Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Educational Session</intervention_name>
    <description>A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker</description>
    <arm_group_label>Brief educational session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  5 to 8 years of age&#xD;
&#xD;
          -  Above the 85th percentile for obesity&#xD;
&#xD;
          -  Accompanied by a parent or legal guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not between the ages of 5 and 8&#xD;
&#xD;
          -  Not above the 85th percentile for obesity.&#xD;
&#xD;
          -  Not accompanied by a parent or legal guardian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maia Ingram</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mariposa Community Health Center</name>
      <address>
        <city>Nogales</city>
        <state>Arizona</state>
        <zip>85621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>childhood obesity</keyword>
  <keyword>intervention</keyword>
  <keyword>community health workers</keyword>
  <keyword>community-based</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>Undecided</sharing_ipd>
    <ipd_description>There is currently no plan in place, however in the future the data dictionaries and individual participant data will be available upon request</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/NCT03781856
org study id: 1710977008
nct id: NCT03781856
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mariposa Community Health Center, a health center in Nogales, Arizona on the US-Mexico
      border, will provide a program to prevent obesity in children and create a community
      environment that supports a healthy lifestyle. Mariposa designed and implemented the La Vida
      Buena ("The Good Life") program and already know that helps families eat more healthily and
      exercise. Mariposa Community Health Center will test this program on younger children aged
      5-8 years old. Providers will refer children who are overweight or obese to the La Vida Buena
      Program. In order to determine if the La Vida Buena program works, Mariposa Community Health
      center will implement the 8-week program with 100 overweight or obese children in their
      Nogales clinic. They will measure their weight (BMI), exercise levels and food habits at the
      beginning of the program and then 3- months and 6-months after the program ends. Mariposa
      will compare these results to children in the nearby Rio Rico clinic who do not receive the
      La Vida Buena program. These 100 overweight or obese children in Rio Rico will instead
      receive one educational session, and the same information will be collected regarding BMI,
      exercise level and food habits. After the 6-month period, the children from Rio Rico will be
      able to receive the full La Vida Buena program.
La Vida Buena is a Mariposa project to educate children and families about healthy eating and
      exercise habits. The Health providers at Mariposa Nogales and Rio Rico clinics will refer
      children between 5-8 years old who are overweight or obese and their parents. Each child must
      participate with a parent or adult caregiver who is at least 18 years old. Before the program
      begins, the participant will attend an informational consent/registration session where they
      will be asked to sign a consent form for themselves and their child if they want to
      participate. The study will ask for certain information from each participant in order to
      determine if the program is working. Each family will respond to a questionnaire at three
      points: at the beginning of the program, three months after beginning the program, and six
      months after beginning the program, for a total of six months.

      The questionnaire will include questions about fruit, vegetable and carbohydrate consumption,
      family behavior and habits regarding eating and exercise, moderate and vigorous physical
      activity, sedentary behavior, local foods and environment factors that impact the family. In
      addition, the child's weight will be measured at each time point.

      Participation in La Vida Buena will take 6 months. At the Nogales site, participants will be
      invited to a series of weekly classes over the course of 8 weeks that are being offered by
      the Mariposa clinic related to child healthy weight, exercise and nutrition. At the Rio Rico
      site, participants will be offered one face to face educational session about child healthy
      weight with Mariposa staff. Participants will be scheduled for BMI measurements and
      questionnaires three months after initiating the program, as well as six months after
      initiating the La Vida Buena Program.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: BMI
time frame: baseline to 6 months follow up
description: Weight and height measured at baseline, post intervention and 6 months.
measure: Physical activity
time frame: baseline to 6 months follow up
description: Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form
measure: Fruit and vegetable consumption
time frame: baseline to 6 months follow up
description: As measured by self reported servings per day or week with higher values considered to be a better outcome
measure: Simple carbohydrate consumption
time frame: baseline to 6 months follow up
description: As measured by self report servings per day or week with lower values considered to be a better outcome
measure: Family healthy habits
time frame: baseline to 6 months follow up
description: As measured by the Family Nutrition and Physical Activity Tool designed to capture healthy family habits. The adapted scale includes 16 items that are score from 1 to 4 that measure physical activity, sport participation, television viewing and video games for their negative influence on child hood obesity. Total score ranges from 16 to 64 points, with an increased score being associated with positive outcomes. There is not threshold or cutoff for the scale.
arm group label: La Vida Buena Program
arm group type: Experimental
description: Administered in a group setting over the course of 8 weeks in a community setting.
arm group label: Brief educational session
arm group type: Active Comparator
description: Administered one on one or in a group setting in a one-hour session at the clinic
intervention type: Behavioral
intervention name: La Vida Buena Program
description: The intervention is series of interactive one hour weekly classes over the course of 8 weeks related to child healthy weight, exercise and nutrition. Facilitated by community health workers, the classes are interactive and play-based and designed to engage both the child and accompanying parent or guardian in activities.
arm group label: La Vida Buena Program
intervention type: Behavioral
intervention name: Brief Educational Session
description: A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker
arm group label: Brief educational session
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maia Ingram
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Undecided
ipd description: There is currently no plan in place, however in the future the data dictionaries and individual participant data will be available upon request