<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/NCT01681108</url>
  </required_header>
  <id_info>
    <org_study_id>06304</org_study_id>
    <nct_id>NCT01681108</nct_id>
  </id_info>
  <brief_title>Childhood Obesity-A Study of Intervention</brief_title>
  <official_title>Childhood Obesity-A Study of Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winthrop University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winthrop University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for&#xD;
      children and adolescents to lose weight and promote their self esteem in a fun atmosphere.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up&#xD;
      Post program, 4) Analysis&#xD;
&#xD;
        1. Screening Children between the ages of 8-16 years of age whose BMI&gt;85th% will be&#xD;
           identified and screened. The parent and their child must agree to participate in the&#xD;
           entire study.&#xD;
&#xD;
           During the first three visits, a full medical evaluation will be performed and it will&#xD;
           be determined if the potential patient meets study entry criteria. Body measurements,&#xD;
           blood collection, family history, behavioral, cardiac, exercise and nutritional&#xD;
           evaluations will take place. Glucose tolerance testing will be performed during&#xD;
           screening. if HbA1c is above 5.2 to classify patients as euglycemic, hyperinsulinemic or&#xD;
           Type 2 Diabetes. Other endocrine evaluations (e.g. FSH, LH, testosterone, Total T4, Free&#xD;
           T4, andandT3, TSH for PCOS and/or thyroid hormone dysfunction) will be performed as&#xD;
           medically indicated. And if medical problems are present, they there will be addressed&#xD;
           and treated by an appropriately medical treatment. In case of PCOS medical treatment is&#xD;
           not enough and diet and exercise should be always part of the treatment.&#xD;
&#xD;
        2. Program Implementation Participants will be entered into the 10-week program. Each child&#xD;
           will act as his/her own control and the success of the interventions will be measured in&#xD;
           change in percentiles over time. Each group will contain no more than 12 participants.&#xD;
           During the program there will be intensive nutrition, behavioral and exercise therapy&#xD;
           designed specifically for each child and for each family participating. The program,&#xD;
           designed for a total of 32 weeks, will include weekly sessions for the first 10 weeks,&#xD;
           every other week for the next 10 weeks, and once a month thereafter.&#xD;
&#xD;
      The design of the intervention is as follows:&#xD;
&#xD;
        1. Individualized meal planning and exercise regimen sessions will be developed for each&#xD;
           participant. .&#xD;
&#xD;
        2. Participants and their families will participate in groups of 10 to 12 where they can&#xD;
           elicit support and motivation from one another, learn about nutrition, behaviors as well&#xD;
           as engage in exercise programs which are facilitated by a certified instructor.&#xD;
&#xD;
        3. Weekly topics will be taught through 'gaming activities' designed to impart educational&#xD;
           information through games and activities. Group support activities will use affective&#xD;
           techniques in order to elicit sharing of feelings.&#xD;
&#xD;
        4. Each discipline involved- behavioral, nutritional and exercise physiology will design&#xD;
           pre and post evaluation tools (in addition to maintaining histories on each participant)&#xD;
           as well as lesson plans, gaming activities and affective techniques. Behavioral issues&#xD;
           such as eating through boredom, stress, or loneliness, for example, might be addressed&#xD;
           in varied ways weaved throughout the 2 ½ hr session, while portion control, appropriate&#xD;
           food choices might be the nutritional topics covered that session and reviewed through&#xD;
           gaming activities. The exercise portion of the lesson may address varied types of&#xD;
           exercise to reduce stress and keep them busy and a yoga instructor may come that night&#xD;
           to demonstrate other stress reduction techniques.&#xD;
&#xD;
      3) Follow-up Post Program After the 32-week program, there will be follow-up visits in order&#xD;
      to assess maintenance of weight loss. Questionnaires and visits at 2 months, 6 months, and 1&#xD;
      year after the program ends will evaluate long-term success.&#xD;
&#xD;
      Subsequent visits will occur every three months which is considered standard of care.&#xD;
&#xD;
      4) Analysis: Pre 10 week session and post 10 week session the following evaluation tools and&#xD;
      criteria will be evaluated: Weight, waist circumference, endurance, strength, flexibility,&#xD;
      triceps caliper measurements as well as the YES evaluation. The Youth Evaluation Scale is a&#xD;
      nationally standardized test. The YES evaluation is performed on ages 9 and &gt; and evaluates&#xD;
      areas such as: habits, knowledge, self esteem, depression, anxiety, family communications,&#xD;
      lifestyle, structure and more.&#xD;
&#xD;
      After years 1 and 2, the study team will evaluate the effectiveness of the program as a whole&#xD;
      and each individual component. Recommendations for design changes, as well as statistical&#xD;
      information from all study members (i.e., behavioral, nutrition, exercise) will be analyzed&#xD;
      to determine the advantages of certain treatment modalities in the effective treatment of&#xD;
      childhood obesity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2006</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI will be measured</measure>
    <time_frame>3 month interval over 1 year</time_frame>
    <description>Data will be collected at routine office visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>3 month interval over 1 year</time_frame>
    <description>Data will be collected at routine office visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 month interval over 1 year</time_frame>
    <description>Data will be collected at routine office visits</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Individualized meal planning and exercise regimen sessions will be developed for each participant</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle counseling</intervention_name>
    <description>Individualized meal planning and exercise regimen sessions will be developed for each participant</description>
    <arm_group_label>Lifestyle counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents between the ages of 8 and 16 years with a BMI &gt; 85th%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children younger then 8 years of age or older then 16 years of age.&#xD;
&#xD;
          -  Children with a BMI &lt; 85th%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siham Accacha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winthrop University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>March 28, 2011</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</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>
  <!-- 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/NCT01681108
org study id: 06304
nct id: NCT01681108
lead sponsor: 
has dmc: Yes
The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for
      children and adolescents to lose weight and promote their self esteem in a fun atmosphere.
The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up
      Post program, 4) Analysis

        1. Screening Children between the ages of 8-16 years of age whose BMI>85th% will be
           identified and screened. The parent and their child must agree to participate in the
           entire study.

           During the first three visits, a full medical evaluation will be performed and it will
           be determined if the potential patient meets study entry criteria. Body measurements,
           blood collection, family history, behavioral, cardiac, exercise and nutritional
           evaluations will take place. Glucose tolerance testing will be performed during
           screening. if HbA1c is above 5.2 to classify patients as euglycemic, hyperinsulinemic or
           Type 2 Diabetes. Other endocrine evaluations (e.g. FSH, LH, testosterone, Total T4, Free
           T4, andandT3, TSH for PCOS and/or thyroid hormone dysfunction) will be performed as
           medically indicated. And if medical problems are present, they there will be addressed
           and treated by an appropriately medical treatment. In case of PCOS medical treatment is
           not enough and diet and exercise should be always part of the treatment.

        2. Program Implementation Participants will be entered into the 10-week program. Each child
           will act as his/her own control and the success of the interventions will be measured in
           change in percentiles over time. Each group will contain no more than 12 participants.
           During the program there will be intensive nutrition, behavioral and exercise therapy
           designed specifically for each child and for each family participating. The program,
           designed for a total of 32 weeks, will include weekly sessions for the first 10 weeks,
           every other week for the next 10 weeks, and once a month thereafter.

      The design of the intervention is as follows:

        1. Individualized meal planning and exercise regimen sessions will be developed for each
           participant. .

        2. Participants and their families will participate in groups of 10 to 12 where they can
           elicit support and motivation from one another, learn about nutrition, behaviors as well
           as engage in exercise programs which are facilitated by a certified instructor.

        3. Weekly topics will be taught through 'gaming activities' designed to impart educational
           information through games and activities. Group support activities will use affective
           techniques in order to elicit sharing of feelings.

        4. Each discipline involved- behavioral, nutritional and exercise physiology will design
           pre and post evaluation tools (in addition to maintaining histories on each participant)
           as well as lesson plans, gaming activities and affective techniques. Behavioral issues
           such as eating through boredom, stress, or loneliness, for example, might be addressed
           in varied ways weaved throughout the 2 ½ hr session, while portion control, appropriate
           food choices might be the nutritional topics covered that session and reviewed through
           gaming activities. The exercise portion of the lesson may address varied types of
           exercise to reduce stress and keep them busy and a yoga instructor may come that night
           to demonstrate other stress reduction techniques.

      3) Follow-up Post Program After the 32-week program, there will be follow-up visits in order
      to assess maintenance of weight loss. Questionnaires and visits at 2 months, 6 months, and 1
      year after the program ends will evaluate long-term success.

      Subsequent visits will occur every three months which is considered standard of care.

      4) Analysis: Pre 10 week session and post 10 week session the following evaluation tools and
      criteria will be evaluated: Weight, waist circumference, endurance, strength, flexibility,
      triceps caliper measurements as well as the YES evaluation. The Youth Evaluation Scale is a
      nationally standardized test. The YES evaluation is performed on ages 9 and > and evaluates
      areas such as: habits, knowledge, self esteem, depression, anxiety, family communications,
      lifestyle, structure and more.

      After years 1 and 2, the study team will evaluate the effectiveness of the program as a whole
      and each individual component. Recommendations for design changes, as well as statistical
      information from all study members (i.e., behavioral, nutrition, exercise) will be analyzed
      to determine the advantages of certain treatment modalities in the effective treatment of
      childhood obesity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMI will be measured
time frame: 3 month interval over 1 year
description: Data will be collected at routine office visits
measure: Weight
time frame: 3 month interval over 1 year
description: Data will be collected at routine office visits
measure: Height
time frame: 3 month interval over 1 year
description: Data will be collected at routine office visits
arm group label: Lifestyle counseling
arm group type: Other
description: Individualized meal planning and exercise regimen sessions will be developed for each participant
intervention type: Behavioral
intervention name: Lifestyle counseling
description: Individualized meal planning and exercise regimen sessions will be developed for each participant
arm group label: Lifestyle counseling
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Siham Accacha, MD
role: Principal Investigator
affiliation: Winthrop University Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity