<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/NCT03235440</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2017-014</org_study_id>
    <nct_id>NCT03235440</nct_id>
  </id_info>
  <brief_title>Feasibility of the Camp Power Up Program on Children's Body Weight and Quality of Life</brief_title>
  <acronym>CampPowerUp</acronym>
  <official_title>Examination of the Acceptance and Feasibility of Implementing the American Diabetes Association's Camp Power Up Program on Changes in Body Weight and Quality of Life Measures in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisiana State University, Baton Rouge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Council on Exercise</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</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>
      This study will evaluate the effects of a one week weight management summer camp on&#xD;
      children's weight, quality of life, mood and feelings, self-esteem, weight management&#xD;
      efficacy, enjoyment of physical activity, and body image.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity affects 17% of children and adolescents in the U.S. Children are entrenched in an&#xD;
      obesogenic environment, often with little support in the home, school, or medical environment&#xD;
      to make healthy choices. Obesity is increasingly common in underserved communities that lack&#xD;
      access and resources for physical activity and healthy eating. Louisiana is a prime example&#xD;
      of the need for effective obesity treatment, ranking 1st nationally for adult obesity and 4th&#xD;
      for adolescent obesity with the highest obesity prevalence among African American&#xD;
      adolescents. We urgently need evidence-based programs to help children and families change&#xD;
      lifestyle behaviors, achieve clinically significant weight loss, and thereby reduce the&#xD;
      prevalence of pediatric obesity.&#xD;
&#xD;
      The U.S. Preventive Services Task Force identifies behavioral treatment including dietary,&#xD;
      physical activity, and behavioral counseling components as a viable option for pediatric&#xD;
      obesity treatment, yet a key challenge is how to implement these programs to maximize access&#xD;
      and participation. Summer (between school years) represents an opportunity for intensive&#xD;
      intervention to change health behaviors and help children to lose weight. During the summer&#xD;
      months, children gain weight at a more rapid pace and spend more time engaged in sedentary&#xD;
      behavior compared to the school year.&#xD;
&#xD;
      The American Diabetes Association launched Camp Power Up as a summer week-long day camp for&#xD;
      youth who are obese and/or at high risk for developing type 2 diabetes. The camp will focus&#xD;
      on wellness education, nutrition, physical activity, and obesity prevention. The purpose of&#xD;
      the proposed study is to examine effects of Camp Power Up on children's weight status and&#xD;
      their psycho-social health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>First day of camp, final day of camp (day 1 and day 5), and 1 month follow up.</time_frame>
    <description>Weight measurement (kg) using a standard scale following the Pennington Biomedical Standard Operating Procedure for weight measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of Weight on Quality of Life (IWQOL): IWQOL-Kids</measure>
    <time_frame>First day and final day of camp (day 1 and day 5)</time_frame>
    <description>a 27-item measure of weight-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory - PedsQL</measure>
    <time_frame>First day and final day of camp (day 1 and day 5)</time_frame>
    <description>The PedsQL is a general health related quality of life self-report measure with :complementary scales for children (ages 6-14). The measure assesses availability, negative emotions, physical discomfort, positive activities, and physical, emotional, social, and school functioning, and provides a social psychosocial summary score as well as a total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Efficacy Lifestyle questionnaire (WEL)</measure>
    <time_frame>First day and final day of camp (day 1 and day 5)</time_frame>
    <description>The WEL assesses self-reported eating habits and perceived self-efficacy in regards to eating and weight loss. The WEL consists of 20 items designed to measure five hypothetical dimensions of efficacy for weight management: availability, negative emotions, physical discomfort, positive activities, and social pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Enjoyment Scale (PACES)</measure>
    <time_frame>First day and final day of camp (day 1 and day 5)</time_frame>
    <description>The PACES is a 16-item measure of enjoyment during physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Image Assessment of Children (BIA-C):</measure>
    <time_frame>First day and final day of camp (day 1 and day 5)</time_frame>
    <description>The BIA-C is a reliable and valid measure of body image in children aged 8-12.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Weight Change, Body</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Kids N Fitness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in a one-week weight-management summer camp consisting of different activities related to moderate-vigorous physical activity (MVPA) and healthy eating. MVPA will consist of modifiable games and activities using a variety of equipment familiar to children of this age, such as balls, hula-hoops, Frisbees, etc., in both competitive and cooperative formats that keep participants moving at all times, and emphasize a feeling of play as opposed to a feeling of exercise. Healthy eating activities are composed of varying classroom-style learning and practical application of knowledge to topics such as recommendations from the MyPlate.gov website, the different types of food groups, and caloric intake and portion sizes, among other various topics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kids N Fitness Program</intervention_name>
    <description>Participants will engage in a one-week weight-management summer camp consisting of different activities related to moderate-vigorous physical activity (MVPA) and healthy eating. MVPA will consist of modifiable games and activities using a variety of equipment familiar to children of this age, such as balls, hula-hoops, Frisbees, etc., in both competitive and cooperative formats that keep participants moving at all times, and emphasize a feeling of play as opposed to a feeling of exercise. Healthy eating activities are composed of varying classroom-style learning and practical application of knowledge to topics such as recommendations from the MyPlate.gov website, the different types of food groups, and caloric intake and portion sizes, among other various topics.</description>
    <arm_group_label>Kids N Fitness</arm_group_label>
    <other_name>Kids N Fitness (KNF) Program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 6 to 14 years&#xD;
&#xD;
          -  Enrolled in the American Diabetes Association (ADA) Camp Power Up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda E Staiano, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Amanda Staiano</investigator_full_name>
    <investigator_title>Assistant Professor - Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03235440
org study id: PBRC 2017-014
nct id: NCT03235440
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effects of a one week weight management summer camp on
      children's weight, quality of life, mood and feelings, self-esteem, weight management
      efficacy, enjoyment of physical activity, and body image.
Obesity affects 17% of children and adolescents in the U.S. Children are entrenched in an
      obesogenic environment, often with little support in the home, school, or medical environment
      to make healthy choices. Obesity is increasingly common in underserved communities that lack
      access and resources for physical activity and healthy eating. Louisiana is a prime example
      of the need for effective obesity treatment, ranking 1st nationally for adult obesity and 4th
      for adolescent obesity with the highest obesity prevalence among African American
      adolescents. We urgently need evidence-based programs to help children and families change
      lifestyle behaviors, achieve clinically significant weight loss, and thereby reduce the
      prevalence of pediatric obesity.

      The U.S. Preventive Services Task Force identifies behavioral treatment including dietary,
      physical activity, and behavioral counseling components as a viable option for pediatric
      obesity treatment, yet a key challenge is how to implement these programs to maximize access
      and participation. Summer (between school years) represents an opportunity for intensive
      intervention to change health behaviors and help children to lose weight. During the summer
      months, children gain weight at a more rapid pace and spend more time engaged in sedentary
      behavior compared to the school year.

      The American Diabetes Association launched Camp Power Up as a summer week-long day camp for
      youth who are obese and/or at high risk for developing type 2 diabetes. The camp will focus
      on wellness education, nutrition, physical activity, and obesity prevention. The purpose of
      the proposed study is to examine effects of Camp Power Up on children's weight status and
      their psycho-social health.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Body Weight
time frame: First day of camp, final day of camp (day 1 and day 5), and 1 month follow up.
description: Weight measurement (kg) using a standard scale following the Pennington Biomedical Standard Operating Procedure for weight measurements.
measure: Impact of Weight on Quality of Life (IWQOL): IWQOL-Kids
time frame: First day and final day of camp (day 1 and day 5)
description: a 27-item measure of weight-related quality of life
measure: Pediatric Quality of Life Inventory - PedsQL
time frame: First day and final day of camp (day 1 and day 5)
description: The PedsQL is a general health related quality of life self-report measure with :complementary scales for children (ages 6-14). The measure assesses availability, negative emotions, physical discomfort, positive activities, and physical, emotional, social, and school functioning, and provides a social psychosocial summary score as well as a total score.
measure: Weight Efficacy Lifestyle questionnaire (WEL)
time frame: First day and final day of camp (day 1 and day 5)
description: The WEL assesses self-reported eating habits and perceived self-efficacy in regards to eating and weight loss. The WEL consists of 20 items designed to measure five hypothetical dimensions of efficacy for weight management: availability, negative emotions, physical discomfort, positive activities, and social pressure.
measure: Physical Activity Enjoyment Scale (PACES)
time frame: First day and final day of camp (day 1 and day 5)
description: The PACES is a 16-item measure of enjoyment during physical activity.
measure: Body Image Assessment of Children (BIA-C):
time frame: First day and final day of camp (day 1 and day 5)
description: The BIA-C is a reliable and valid measure of body image in children aged 8-12.
arm group label: Kids N Fitness
arm group type: Experimental
description: Participants will engage in a one-week weight-management summer camp consisting of different activities related to moderate-vigorous physical activity (MVPA) and healthy eating. MVPA will consist of modifiable games and activities using a variety of equipment familiar to children of this age, such as balls, hula-hoops, Frisbees, etc., in both competitive and cooperative formats that keep participants moving at all times, and emphasize a feeling of play as opposed to a feeling of exercise. Healthy eating activities are composed of varying classroom-style learning and practical application of knowledge to topics such as recommendations from the MyPlate.gov website, the different types of food groups, and caloric intake and portion sizes, among other various topics.
intervention type: Behavioral
intervention name: Kids N Fitness Program
description: Participants will engage in a one-week weight-management summer camp consisting of different activities related to moderate-vigorous physical activity (MVPA) and healthy eating. MVPA will consist of modifiable games and activities using a variety of equipment familiar to children of this age, such as balls, hula-hoops, Frisbees, etc., in both competitive and cooperative formats that keep participants moving at all times, and emphasize a feeling of play as opposed to a feeling of exercise. Healthy eating activities are composed of varying classroom-style learning and practical application of knowledge to topics such as recommendations from the MyPlate.gov website, the different types of food groups, and caloric intake and portion sizes, among other various topics.
arm group label: Kids N Fitness
other name: Kids N Fitness (KNF) Program
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda E Staiano, Ph.D.
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Amanda Staiano
investigator title: Assistant Professor - Research
mesh term: Pediatric Obesity
mesh term: Body Weight
mesh term: Body Weight Changes
sharing ipd: No
submitted: July 5, 2023