<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/NCT04505085</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00106052</org_study_id>
    <nct_id>NCT04505085</nct_id>
  </id_info>
  <brief_title>Active Dads Healthy Families</brief_title>
  <official_title>Active Dads Healthy Families: Promoting Physical Activity and Enhancing Father-child Relationships Through Parks and Recreation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke 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 is to evaluate the feasibility of implementing a&#xD;
      community-delivered physical activity program for fathers and their children ages 2-5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate the feasibility of a community-based father-child physical&#xD;
      activity promotion program. The investigators will work with a local Parks and Recreation&#xD;
      department to recruit and deliver programming to three cohorts of fathers and their children&#xD;
      2-5 years old. To evaluate program feasibility, the investigators will assess recruitment&#xD;
      efforts, program attendance, and participant engagement and satisfaction with the program.&#xD;
      The investigators will also assess change in father-child outcomes post program including&#xD;
      objectively measured physical activity, fathers' parenting, and father involvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2021</start_date>
  <completion_date type="Actual">November 5, 2021</completion_date>
  <primary_completion_date type="Actual">November 5, 2021</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>
    <intervention_model_description>A non-randomized quasi-experimental design will be used to evaluate the feasibility of the Active Dads Healthy Families intervention, and provide preliminary data of changes over time and between two forms of the intervention. The investigators will recruit two cohorts totaling 30 father-child dyads (15 per cohort) to take part in the 8-week program delivered by Parks and Recreation. The primary outcome is program feasibility.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment as measured by number of participants who enroll</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Attendance as measured by number of participants present at each session</measure>
    <time_frame>Baseline through 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of participation in physical activity during each session</measure>
    <time_frame>Baseline through 8 weeks</time_frame>
    <description>As measured by observation using the System for Observing Fitness Instruction Time (SOFIT) instrument, activity scores range from 1 &quot;lying down&quot; to 5 &quot;vigorous&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants satisfied with the program as measured by self-report evaluation survey</measure>
    <time_frame>8 weeks</time_frame>
    <description>Self-report program evaluation survey; 13 items with responses ranging from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants who complete all study measures</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants who complete all study measures</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in moderate to vigorous physical activity as measured by accelerometry</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Child objectively measured physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in moderate to vigorous physical activity as measured by accelerometry</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Father objectively measured physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in father support for child physical activity as measured by father self-report</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>15-item engagement subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent engagement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in father physical activity psychological control as measured by father self-report</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>5-item psychological control subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent psychological control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in father involvement in physical play as measured by father self-report</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>9-item scale about father involvement in physical play, scored by calculating the mean of all items (range 1-6), with higher scores indicating greater father involvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in father involvement in care-giving as measured by father self-report</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>13-item scale about father involvement in care-giving, scored by calculating the mean of all items (range 1-6), with higher scores indicate greater father involvement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Active Dads Healthy Families: Outdoor Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Dads Healthy Families: Fitness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Dads Healthy Families: Outdoor Education</intervention_name>
    <description>The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.</description>
    <arm_group_label>Active Dads Healthy Families: Outdoor Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Dads Healthy Families: Fitness</intervention_name>
    <description>The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.</description>
    <arm_group_label>Active Dads Healthy Families: Fitness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Father or father figure to child between the ages 2-5 years&#xD;
&#xD;
          -  Father or father figure 18+ years&#xD;
&#xD;
          -  Can speak and read in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Father or child has a physical disability precluding them from being physically active&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah C Armstrong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham Parks and Recreation</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>parenting</keyword>
  <keyword>exercise</keyword>
  <keyword>family-based</keyword>
  <keyword>father</keyword>
  <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/NCT04505085
org study id: Pro00106052
nct id: NCT04505085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility of implementing a
      community-delivered physical activity program for fathers and their children ages 2-5 years.
The investigators will evaluate the feasibility of a community-based father-child physical
      activity promotion program. The investigators will work with a local Parks and Recreation
      department to recruit and deliver programming to three cohorts of fathers and their children
      2-5 years old. To evaluate program feasibility, the investigators will assess recruitment
      efforts, program attendance, and participant engagement and satisfaction with the program.
      The investigators will also assess change in father-child outcomes post program including
      objectively measured physical activity, fathers' parenting, and father involvement.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: A non-randomized quasi-experimental design will be used to evaluate the feasibility of the Active Dads Healthy Families intervention, and provide preliminary data of changes over time and between two forms of the intervention. The investigators will recruit two cohorts totaling 30 father-child dyads (15 per cohort) to take part in the 8-week program delivered by Parks and Recreation. The primary outcome is program feasibility.
primary purpose: Prevention
masking: None (Open Label)
measure: Recruitment as measured by number of participants who enroll
time frame: Baseline
measure: Attendance as measured by number of participants present at each session
time frame: Baseline through 8 weeks
measure: Degree of participation in physical activity during each session
time frame: Baseline through 8 weeks
description: As measured by observation using the System for Observing Fitness Instruction Time (SOFIT) instrument, activity scores range from 1 "lying down" to 5 "vigorous"
measure: Percent of participants satisfied with the program as measured by self-report evaluation survey
time frame: 8 weeks
description: Self-report program evaluation survey; 13 items with responses ranging from 1 "strongly disagree" to 5 "strongly agree"
measure: Percent of participants who complete all study measures
time frame: Baseline
measure: Percent of participants who complete all study measures
time frame: 8 weeks
measure: Change in moderate to vigorous physical activity as measured by accelerometry
time frame: Baseline, 8 weeks
description: Child objectively measured physical activity
measure: Change in moderate to vigorous physical activity as measured by accelerometry
time frame: Baseline, 8 weeks
description: Father objectively measured physical activity
measure: Change in father support for child physical activity as measured by father self-report
time frame: Baseline, 8 weeks
description: 15-item engagement subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent engagement
measure: Change in father physical activity psychological control as measured by father self-report
time frame: Baseline, 8 weeks
description: 5-item psychological control subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent psychological control
measure: Change in father involvement in physical play as measured by father self-report
time frame: Baseline, 8 weeks
description: 9-item scale about father involvement in physical play, scored by calculating the mean of all items (range 1-6), with higher scores indicating greater father involvement
measure: Change in father involvement in care-giving as measured by father self-report
time frame: Baseline, 8 weeks
description: 13-item scale about father involvement in care-giving, scored by calculating the mean of all items (range 1-6), with higher scores indicate greater father involvement
arm group label: Active Dads Healthy Families: Outdoor Education
arm group type: Experimental
description: The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
arm group label: Active Dads Healthy Families: Fitness
arm group type: Experimental
description: The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
intervention type: Behavioral
intervention name: Active Dads Healthy Families: Outdoor Education
description: The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
arm group label: Active Dads Healthy Families: Outdoor Education
intervention type: Behavioral
intervention name: Active Dads Healthy Families: Fitness
description: The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
arm group label: Active Dads Healthy Families: Fitness
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah C Armstrong, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No