<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/NCT03761589</url>
  </required_header>
  <id_info>
    <org_study_id>14SDG20490382</org_study_id>
    <nct_id>NCT03761589</nct_id>
  </id_info>
  <brief_title>Efficacy of the Athletes for Life Program to Promote Cardiovascular Health</brief_title>
  <acronym>AFL</acronym>
  <official_title>Community-Academic Partnership to Promote Cardiovascular Health Among Underserved Children and Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</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 purpose of this study was to test the efficacy of a fitness- and behavioral-focused&#xD;
      intervention, Athletes for Life (AFL), to improve cardiorespiratory fitness (CRF) among 160&#xD;
      underserved families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Athletes for Life (AFL) study was a 12-week randomized controlled trial designed to&#xD;
      promote cardiorespiratory fitness (CRF) and healthy lifestyle changes among parents and&#xD;
      children. The original enrollment target was 160 families. A total of 149 parent-child dyads&#xD;
      living in a Southwestern U.S. metropolitan area were enrolled in the study. AFL consisting of&#xD;
      24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented&#xD;
      sessions, and was delivered in a municipal recreation center. Behavior change, including&#xD;
      increased physical activity, and adherence were motivated through positive reinforcement&#xD;
      techniques. Families were randomized to either the AFL program or a wait-list control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Families (i.e., children and parents/primary caregivers dyads) were randomly assigned to participate in either the intervention group or a wait-list control group. The intervention (AFL) consisted of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center. The wait-list control group received the intervention after all follow-up data had been collected. Data from all participants (both intervention group and wait-list group) were collected in four phases: before the intervention group started the program (week 0) and at 6, 12, and 24 weeks, thereafter.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cardiovascular fitness (total seconds)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in insulin concentration (uIU/mL)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child and adult insulin concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose concentration (mg/dL)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child and adult glucose concentrations (plasma values) were measured via lipid panels and analyzed using Cobas automated analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglyceride concentrations (mg/dL)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child and adult triglyceride concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total low-density lipoprotein (LDL) (mg/dL)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child and adult LDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total high-density lipoprotein (HDL) (mg/dL)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child and adult HDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average systolic blood pressure (mmHg)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult systolic blood pressure was measured by an automated pressure cuff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average diastolic blood pressure (mmHg)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult diastolic blood pressure was measured by an automated pressure cuff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total percent body fat (%)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult percent body fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total abdominal fat mass (g)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult abdominal fat mass was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total trunk percent fat (%)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult trunk percent fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference (inches)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult waist circumference was measured via a tape measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI) (kg/m^2)</measure>
    <time_frame>0, 12, and 24 weeks</time_frame>
    <description>Child and adult BMI values were calculated using multiple measurements of height (cm) and weight (kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of fruit and vegetable consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child consumption of fruit and vegetables within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of dairy food consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child consumption of dairy foods (i.e., cheese, milk and yogurt) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of protein consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child protein consumption (i.e., meat, fish, eggs and beans) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of drink consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child consumption of drinks other than milk and 100% fruit juice (i.e., water, soda, and flavored drinks) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of fat and sugar consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child consumption of fats and sugars (e.g., butter, potato chips, pastries) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of grain consumption (times per month)</measure>
    <time_frame>0 and 12 weeks</time_frame>
    <description>Child consumption of grains (e.g., cereals, brown rice, pasta) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity (minutes per day of MVPA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Child and adult 7-day physical activity (i.e., sedentary, moderate/vigorous activity) was measured using GENEActiv accelerometers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Cardiovascular Fitness</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>AFL Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The AFL intervention consisted of twice a week physical activity and nutrition sessions for children and twice a week educational and physical activity sessions for parents. Each session lasted 90 minutes and all sessions were conducted in a municipal recreation center. The child program was delivered in English while the parent program was delivered in separate English-only or Spanish-only classes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The wait-list control group received the 12-week AFL intervention after all follow-up data had been completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AFL Intervention</intervention_name>
    <description>The AFL intervention consisted of two 90-minute sessions per week for 12 months for both children and parents. The child physical activity sessions, held separately from the parent sessions, aimed to achieve 60 minutes of moderate-to-vigorous physical activity during each session through structured play activities, athletic drills, and sport exercises. Child dietary behaviors were taught through educational activities in small groups. For the parent program, behavior modification techniques were used to guide parents toward changing their own and their child's behavior. Take-home materials for self-monitoring of behaviors were used for both the child and the parent in order to reinforce concepts discussed in class.</description>
    <arm_group_label>AFL Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wait-List Control</intervention_name>
    <description>Families that were randomly assigned to the wait-list control group were asked not to change their normal physical activity or dietary behaviors for the duration of the 12-week waiting period. They were asked to participate in the baseline and 12-week evaluations and then they were enrolled to receive the 12-week intervention.</description>
    <arm_group_label>Wait-List Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent ages 18 years and over&#xD;
&#xD;
          -  Child ages 6-11 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a mental or physical condition that was contraindicated to participating&#xD;
             in sports/exercise&#xD;
&#xD;
          -  Having a chronic condition that limited mobility&#xD;
&#xD;
          -  Taking medications that influenced body composition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noe C Crespo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Behavioral and Community Health</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Noe Crespo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiovascular fitness</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Obesity</keyword>
  <keyword>Children</keyword>
  <keyword>Adults</keyword>
  <!-- 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/NCT03761589
org study id: 14SDG20490382
nct id: NCT03761589
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to test the efficacy of a fitness- and behavioral-focused
      intervention, Athletes for Life (AFL), to improve cardiorespiratory fitness (CRF) among 160
      underserved families.
The Athletes for Life (AFL) study was a 12-week randomized controlled trial designed to
      promote cardiorespiratory fitness (CRF) and healthy lifestyle changes among parents and
      children. The original enrollment target was 160 families. A total of 149 parent-child dyads
      living in a Southwestern U.S. metropolitan area were enrolled in the study. AFL consisting of
      24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented
      sessions, and was delivered in a municipal recreation center. Behavior change, including
      increased physical activity, and adherence were motivated through positive reinforcement
      techniques. Families were randomized to either the AFL program or a wait-list control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Families (i.e., children and parents/primary caregivers dyads) were randomly assigned to participate in either the intervention group or a wait-list control group. The intervention (AFL) consisted of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center. The wait-list control group received the intervention after all follow-up data had been collected. Data from all participants (both intervention group and wait-list group) were collected in four phases: before the intervention group started the program (week 0) and at 6, 12, and 24 weeks, thereafter.
primary purpose: Other
masking: Single (Participant)
measure: Change in cardiovascular fitness (total seconds)
time frame: 0, 12, and 24 weeks
description: Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test
measure: Change in insulin concentration (uIU/mL)
time frame: 0 and 12 weeks
description: Child and adult insulin concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
measure: Change in glucose concentration (mg/dL)
time frame: 0 and 12 weeks
description: Child and adult glucose concentrations (plasma values) were measured via lipid panels and analyzed using Cobas automated analyzer.
measure: Change in triglyceride concentrations (mg/dL)
time frame: 0 and 12 weeks
description: Child and adult triglyceride concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
measure: Change in total low-density lipoprotein (LDL) (mg/dL)
time frame: 0 and 12 weeks
description: Child and adult LDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
measure: Change in total high-density lipoprotein (HDL) (mg/dL)
time frame: 0 and 12 weeks
description: Child and adult HDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
measure: Change in average systolic blood pressure (mmHg)
time frame: 0, 12, and 24 weeks
description: Child and adult systolic blood pressure was measured by an automated pressure cuff.
measure: Change in average diastolic blood pressure (mmHg)
time frame: 0, 12, and 24 weeks
description: Child and adult diastolic blood pressure was measured by an automated pressure cuff.
measure: Change in total percent body fat (%)
time frame: 0, 12, and 24 weeks
description: Child and adult percent body fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
measure: Change in total abdominal fat mass (g)
time frame: 0, 12, and 24 weeks
description: Child and adult abdominal fat mass was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
measure: Change in total trunk percent fat (%)
time frame: 0, 12, and 24 weeks
description: Child and adult trunk percent fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
measure: Change in waist circumference (inches)
time frame: 0, 12, and 24 weeks
description: Child and adult waist circumference was measured via a tape measure.
measure: Change in Body Mass Index (BMI) (kg/m^2)
time frame: 0, 12, and 24 weeks
description: Child and adult BMI values were calculated using multiple measurements of height (cm) and weight (kg).
measure: Frequency of fruit and vegetable consumption (times per month)
time frame: 0 and 12 weeks
description: Child consumption of fruit and vegetables within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Frequency of dairy food consumption (times per month)
time frame: 0 and 12 weeks
description: Child consumption of dairy foods (i.e., cheese, milk and yogurt) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Frequency of protein consumption (times per month)
time frame: 0 and 12 weeks
description: Child protein consumption (i.e., meat, fish, eggs and beans) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Frequency of drink consumption (times per month)
time frame: 0 and 12 weeks
description: Child consumption of drinks other than milk and 100% fruit juice (i.e., water, soda, and flavored drinks) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Frequency of fat and sugar consumption (times per month)
time frame: 0 and 12 weeks
description: Child consumption of fats and sugars (e.g., butter, potato chips, pastries) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Frequency of grain consumption (times per month)
time frame: 0 and 12 weeks
description: Child consumption of grains (e.g., cereals, brown rice, pasta) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
measure: Change in physical activity (minutes per day of MVPA)
time frame: 12 weeks
description: Child and adult 7-day physical activity (i.e., sedentary, moderate/vigorous activity) was measured using GENEActiv accelerometers.
arm group label: AFL Intervention Group
arm group type: Experimental
description: The AFL intervention consisted of twice a week physical activity and nutrition sessions for children and twice a week educational and physical activity sessions for parents. Each session lasted 90 minutes and all sessions were conducted in a municipal recreation center. The child program was delivered in English while the parent program was delivered in separate English-only or Spanish-only classes.
arm group label: Wait-List Control Group
arm group type: Other
description: The wait-list control group received the 12-week AFL intervention after all follow-up data had been completed.
intervention type: Behavioral
intervention name: AFL Intervention
description: The AFL intervention consisted of two 90-minute sessions per week for 12 months for both children and parents. The child physical activity sessions, held separately from the parent sessions, aimed to achieve 60 minutes of moderate-to-vigorous physical activity during each session through structured play activities, athletic drills, and sport exercises. Child dietary behaviors were taught through educational activities in small groups. For the parent program, behavior modification techniques were used to guide parents toward changing their own and their child's behavior. Take-home materials for self-monitoring of behaviors were used for both the child and the parent in order to reinforce concepts discussed in class.
arm group label: AFL Intervention Group
intervention type: Behavioral
intervention name: Wait-List Control
description: Families that were randomly assigned to the wait-list control group were asked not to change their normal physical activity or dietary behaviors for the duration of the 12-week waiting period. They were asked to participate in the baseline and 12-week evaluations and then they were enrolled to receive the 12-week intervention.
arm group label: Wait-List Control Group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noe C Crespo, PhD
role: Principal Investigator
affiliation: San Diego State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Noe Crespo
investigator title: Assistant Professor