<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/NCT02262013</url>
  </required_header>
  <id_info>
    <org_study_id>HM20003076</org_study_id>
    <nct_id>NCT02262013</nct_id>
  </id_info>
  <brief_title>Evaluation of a Family-based Pediatric Obesity Program: TEENS+</brief_title>
  <official_title>Evaluation of a Family-based Pediatric Obesity Program: TEENS+</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the&#xD;
      feasibility of this dietary intervention strategy and preliminary effectiveness of two models&#xD;
      of parental involvement within adolescent obesity treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will recruit overweight or obese adolescents (BMI &gt;85th percentile) and&#xD;
      parent(s) (BMI &gt;25 kg/m2). Families will participate in one of two 6-month treatments: 1)&#xD;
      TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight&#xD;
      management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight&#xD;
      management. All adolescents will participate in TEENS+, which includes behavioral support,&#xD;
      nutrition education, and supervised physical activity.&#xD;
&#xD;
      For the adolescents, intervention will consist of weekly 1 hour exercise sessions and&#xD;
      alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend&#xD;
      the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent&#xD;
      behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL).&#xD;
      Assessments will consist of anthropometric measures, lab work, psychological surveys, and&#xD;
      nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months&#xD;
      (post-intervention), and 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI z-scores (adolescents and parents)</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Insulin Sensitivity</measure>
    <time_frame>6 months, 9 months</time_frame>
    <description>Insulin, Glucose, HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Serum Lipids</measure>
    <time_frame>6 months, 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Energy Balance</measure>
    <time_frame>6 months, 9 months</time_frame>
    <description>Adipokines, Cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Blood Pressure</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Psychosocial Measures</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dietary Intake</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Parents as Coaches</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent Weight Loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parents as Coaches</intervention_name>
    <description>Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.</description>
    <arm_group_label>Parents as Coaches</arm_group_label>
    <other_name>TEENS+PAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Weight Loss</intervention_name>
    <description>Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.</description>
    <arm_group_label>Parent Weight Loss</arm_group_label>
    <other_name>TEENS+PWL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Overweight (BMI ≥85% percentile for age and gender according to the CDC&#xD;
        Growth Charts) males and females between the age of 12 and 17 years will be eligible for&#xD;
        study participation. In order to be eligible, the adolescent must also reside with the&#xD;
        primary participating parent, who has a BMI ≥25 kg/m 2 and is also willing to participate&#xD;
        in the study protocol. Eligible families must live within a 30 mile radius of the Healthy&#xD;
        Lifestyles Center (HLC) at Children's Hospital of Richmond (CHoR) at VCU where the&#xD;
        interventions will be conducted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Adolescents and parents will be ineligible for study participation under the following&#xD;
        conditions: 1) non-English speaking; 2) medical condition(s) that may be associated with&#xD;
        unintentional weight change (e.g., hypothalamic injury, Prader-Willi, or malignancy); 3)&#xD;
        diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with&#xD;
        glucose intolerance or &quot;pre-diabetes&quot; will eligible for study participation); 4) use of&#xD;
        oral glucocorticoids, atypical antipsychotics, weight loss medications, or an&#xD;
        investigational medication within 3 months of study participation; 5) medical condition(s)&#xD;
        that may be negatively impacted by exercise; 6) physical limitation affected the ability to&#xD;
        exercise, 7) psychiatric, cognitive or developmental conditions that would impair the&#xD;
        adolescent's ability to complete assessments or participate in a group; 8) reports of&#xD;
        compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3&#xD;
        months; 9) current pregnancy or plan to become pregnant during study period; 10) previous&#xD;
        participation in TEENS or NOURISH; 11) current participation in another weight loss&#xD;
        program; or 12) personal history of weight loss surgery.&#xD;
&#xD;
        Adolescents and parents taking metformin, oral contraceptives, tricyclic antidepressants&#xD;
        (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be&#xD;
        eligible for participation; however, subjects must be on a stable dose of medication for at&#xD;
        least 3 months prior to study participation.&#xD;
&#xD;
        In addition, adolescents will be excluded from participation (and referred for further&#xD;
        evaluation) based on the results of baseline psychological assessments under the following&#xD;
        circumstances: 1) clinically significant depression, evidenced by elevations (&gt;20) on CDI;&#xD;
        2) suicidality as reported on CDI or during screening / behavioral interview; 3) psychosis,&#xD;
        4) clinical impairment in Activities of Daily Living and Functional Communication (i.e.,&#xD;
        expressive and receptive communication; and 3) clinically significant eating disorder based&#xD;
        on EDE-Q.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edmond P Wickham, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Richmond at VCU Healthy Lifestyles Center</name>
      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <zip>23239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>February 8, 2017</last_update_submitted>
  <last_update_submitted_qc>February 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric Obesity</keyword>
  <keyword>Lifestyle Intervention</keyword>
  <keyword>Family-based Intervention</keyword>
  <keyword>Motivational Interviewing</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>
  <!-- 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/NCT02262013
org study id: HM20003076
nct id: NCT02262013
lead sponsor: 
has dmc: Yes
Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the
      feasibility of this dietary intervention strategy and preliminary effectiveness of two models
      of parental involvement within adolescent obesity treatment.
Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and
      parent(s) (BMI >25 kg/m2). Families will participate in one of two 6-month treatments: 1)
      TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight
      management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight
      management. All adolescents will participate in TEENS+, which includes behavioral support,
      nutrition education, and supervised physical activity.

      For the adolescents, intervention will consist of weekly 1 hour exercise sessions and
      alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend
      the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent
      behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL).
      Assessments will consist of anthropometric measures, lab work, psychological surveys, and
      nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months
      (post-intervention), and 9 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in BMI z-scores (adolescents and parents)
time frame: 3 months, 6 months, 9 months
measure: Changes in Insulin Sensitivity
time frame: 6 months, 9 months
description: Insulin, Glucose, HbA1c
measure: Changes in Serum Lipids
time frame: 6 months, 9 months
measure: Changes in Energy Balance
time frame: 6 months, 9 months
description: Adipokines, Cytokines
measure: Changes in Blood Pressure
time frame: 3 months, 6 months, 9 months
measure: Changes in Psychosocial Measures
time frame: 3 months, 6 months, 9 months
measure: Changes in Dietary Intake
time frame: 3 months, 6 months, 9 months
arm group label: Parents as Coaches
arm group type: Active Comparator
description: PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.
arm group label: Parent Weight Loss
arm group type: Experimental
description: In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program.
intervention type: Behavioral
intervention name: Parents as Coaches
description: Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.
arm group label: Parents as Coaches
other name: TEENS+PAC
intervention type: Behavioral
intervention name: Parent Weight Loss
description: Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
arm group label: Parent Weight Loss
other name: TEENS+PWL
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edmond P Wickham, MD, MPH
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity