<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/NCT01704768</url>
  </required_header>
  <id_info>
    <org_study_id>5R01NR012171</org_study_id>
    <secondary_id>1R01NR012171-01A2</secondary_id>
    <nct_id>NCT01704768</nct_id>
  </id_info>
  <brief_title>COPE/Healthy Lifestyles for Teens: A School-Based RCT</brief_title>
  <official_title>COPE/Healthy Lifestyles for Teens: A School-Based RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevention and treatment of obesity and mental health disorders in adolescence are two&#xD;
      major public health problems in the United States today. To address the increasing incidence&#xD;
      and adverse health outcomes associated with both obesity and mental health problems, a&#xD;
      theory-based 15 session intervention program entitled COPE (Creating Opportunities for&#xD;
      Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions &amp; Exercise), will&#xD;
      be delivered within high school health classes in order to improve the physical and mental&#xD;
      health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevention and treatment of obesity and mental health disorders in adolescence are two&#xD;
      major public health problems in the United States (U.S.) today. The incidence of adolescents&#xD;
      who are overweight or obese has increased dramatically over the past 20 years, with&#xD;
      approximately 17.1 percent of teens now being overweight or obese. Furthermore, approximately&#xD;
      15 million children and adolescents (25 percent) in the U.S. have a mental health problem&#xD;
      that is interfering with their functioning at home or at school, but less than 25 percent of&#xD;
      those affected receive any treatment for these disorders. The prevalence rates of obesity and&#xD;
      mental health problems are even higher in Hispanic teens, with studies suggesting that the&#xD;
      two conditions often coexist in many youth. However, despite the rapidly increasing incidence&#xD;
      of these two public health problems with their related health disparities and adverse health&#xD;
      outcomes, there has been a paucity of theory based intervention studies conducted with&#xD;
      adolescents in high schools to improve their healthy lifestyle behaviors as well as their&#xD;
      physical and mental health outcomes. Unfortunately, physical and mental health services&#xD;
      continue to be largely separated instead of integrated in the nation's healthcare system,&#xD;
      which often leads to inadequate identification and treatment of these significant adolescent&#xD;
      health problems.&#xD;
&#xD;
      Therefore, the goal of the proposed randomized controlled trial is to test the efficacy of&#xD;
      the COPE(Creating Opportunities for Personal Empowerment)/Healthy Lifestyles TEEN (Thinking,&#xD;
      Feeling, Emotions &amp; Exercise) Program, an educational and cognitive-behavioral skills&#xD;
      building intervention guided by cognitive behavior theory, on the healthy lifestyle behaviors&#xD;
      and depressive symptoms of 800 culturally diverse adolescents enrolled in Phoenix, Arizona&#xD;
      high schools. The specific aims of the study are to: (1) Use a randomized controlled trial to&#xD;
      test the short- and more long-term efficacy of the COPE TEEN Program on key outcomes,&#xD;
      including healthy lifestyles behaviors, depressive symptoms and body mass index percentage,&#xD;
      (2) Examine the role of cognitive beliefs and perceived difficulty in leading a healthy&#xD;
      lifestyle in mediating the effects of COPE on healthy lifestyle behaviors and depressive&#xD;
      symptoms; and (3) Explore variables that may moderate the effects of the intervention on&#xD;
      healthy lifestyle behaviors and depressive symptoms, including race/ethnicity, gender, SES,&#xD;
      acculturation, and parental healthy lifestyle beliefs and behaviors. Six prior pilot studies&#xD;
      support the need for this full scale clinical trial and the use of cognitive-behavioral&#xD;
      skills building in promoting healthy lifestyles beliefs, behaviors and optimal mental health&#xD;
      in teens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Mass Index Percentage (BMI%)</measure>
    <time_frame>Change from Baseline to 12-Month Post intervention</time_frame>
    <description>Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Healthy Lifestyle Behaviors</measure>
    <time_frame>Change from Baseline to 12-Month Post intervention</time_frame>
    <description>Healthy lifestyle behaviors will be measured with the Healthy Lifestyle Behaviors Scale developed for use in our preliminary studies. we also will employ pedometers to objectively quantify activity. Teens will be trained in the use of the pedometer. Pedometers provide a valid and reliable means to measure habitual physical activity in youth to be used as a measure of the students Healthy Lifestyles Behaviors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression and Anxiety Symptoms</measure>
    <time_frame>Change from Baseline to 15-Week Post intervention</time_frame>
    <description>Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Skills</measure>
    <time_frame>15-Week Post</time_frame>
    <description>Social Skills are measured utilizing the Social Skills Rating System (SSRS), a commercial tool that is commonly utilized in research. The SSRS is completed by the student's health teacher.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Academic Performance</measure>
    <time_frame>15-Week Post</time_frame>
    <description>Academic performance is measured utilizing the student's health class grades</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Mass Index Percentile (%)</measure>
    <time_frame>Change from Baseline to 6-Month post intervention</time_frame>
    <description>Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Healthy Lifestyle Behaviors</measure>
    <time_frame>Change from Baseline to 6-Month Post intervention</time_frame>
    <description>Healthy lifestyle behaviors will be measured with the Healthy Lifestyle Behaviors Scale developed for use in our preliminary studies. we also will employ pedometers to objectively quantify activity. Teens will be trained in the use of the pedometer. Pedometers provide a valid and reliable means to measure habitual physical activity in youth to be used as a measure of the students Healthy Lifestyles Behaviors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression and Anxiety Symptoms</measure>
    <time_frame>Change from Baseline to 6-Month Post intervention</time_frame>
    <description>Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression and Anxiety Symptoms</measure>
    <time_frame>Change from Baseline to 12-Month Post intervention</time_frame>
    <description>Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Healthy Lifestyles Beliefs</measure>
    <time_frame>Change from Baseline to 15-Week Post intervention</time_frame>
    <description>Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Difficulty of Leading a Healthy Lifestyle</measure>
    <time_frame>Change from Baseline to 15-Week Post intervention</time_frame>
    <description>Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 15-Week Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Healthy Lifestyles Beliefs</measure>
    <time_frame>Change from Baseline to 6-Months Post intervention</time_frame>
    <description>Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Healthy Lifestyles Beliefs</measure>
    <time_frame>Change from Baseline to 12-Month Post intervention</time_frame>
    <description>Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Difficulty of Leading a Healthy Lifestyle</measure>
    <time_frame>Change from Baseline to 6-Month Post intervention</time_frame>
    <description>Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Difficulty of Leading a Healthy Lifestyle</measure>
    <time_frame>Change from Baseline to 12-Month Post intervention</time_frame>
    <description>Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 15-Week Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High-Density Lipoprotein (HDL)(Lipid Panels)</measure>
    <time_frame>Change from Baseline to 15-Week Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low-Density Lipoprotein (LDL) (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 15-Week Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 6-Month Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 6-Month Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High-Density Lipoprotein (HDL) (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 6-Month Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low-Density Lipoprotein (LDL) (Lipid Panels)</measure>
    <time_frame>Change from Baseline to 6-Month Post Intervention</time_frame>
    <description>Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1219</enrollment>
  <condition>Healthy Lifestyle Behaviors</condition>
  <condition>Depressive/Anxiety Symptoms</condition>
  <arm_group>
    <arm_group_label>COPE/Healthy Lifestyles TEEN Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPE is a manualized 15-session educational and cognitive-behavioral skills building program guided by Cognitive Behavioral Theory with physical activity as a component of each session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Teens Attention Control Program</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy Teens is an attention control program that controls for the time spent with the adolescents in the COPE group is essential to determining the efficacy of the experimental program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COPE/Healthy Lifestyles TEEN Program.</intervention_name>
    <description>The COPE Program is the intervention curriculum delivered to one arm of the study. Each session of COPE contains 15 to 20 minutes of physical activity (e.g., walking, dancing), not as an exercise training program, but rather to build beliefs/confidence in the teens that they can engage in and sustain some level of physical activity on a regular basis. Those healthy lifestyle intervention programs that have employed exercise interventions only have not led to sustained changes in healthy lifestyle behaviors. Our program is designed to enhance healthy lifestyle behaviors and sustain them because life-long cognitive-behavioral skills are taught in the program. Because the COPE TEEN program is completely manualized for the teens and instructors, it can be easily implemented by health teachers in high school settings.</description>
    <arm_group_label>COPE/Healthy Lifestyles TEEN Program</arm_group_label>
    <other_name>Cognitive-Behavioral Skills Building</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Teens Attention Control Program</intervention_name>
    <description>The Healthy Teens program is an attention control program that will assist in ruling out alternative explanations of the mechanism by which the intervention works. It will be standardized like the COPE program to insure that it can be evaluated. It will be administered in a format like that of the COPE intervention program, and will include the same number and length of sessions, except for that it will not include the theoretical active components of CBT and will not include theoretical mechanisms to produce our hypothesized changes in outcomes. Teens in the attention control group also will receive the sessions in their required health class. The difference between the two programs will lie in the content of the sessions, with the Healthy Teens program being focused on safety and common health topics/issues for teens (e.g., road safety, skin care, acne, sun safety).</description>
    <arm_group_label>Healthy Teens Attention Control Program</arm_group_label>
    <other_name>Educational</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Teens and parents of any gender, ethnicity/race, or socioeconomic status.&#xD;
&#xD;
          -  Teens 14 to 16 years of age who are freshmen and sophomores taking a health class at&#xD;
             one of the participating high schools.&#xD;
&#xD;
          -  Teens who assent to participation.&#xD;
&#xD;
          -  Teens with a custodial parent who consents for themselves and their teen's&#xD;
             participation in the study.&#xD;
&#xD;
          -  Teens who can speak and read in English (educational instruction in Arizona High&#xD;
             Schools is conducted in English)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teens who are under age 14 will be excluded because:&#xD;
&#xD;
               -  They are not likely to be enrolled in high school, and&#xD;
&#xD;
               -  They are unlikely to have sufficient cognitive development to benefit from the&#xD;
                  proposed intervention&#xD;
&#xD;
          -  Teens who are over age 16 will be excluded for two key reasons:&#xD;
&#xD;
               -  We believe that the cognitive development of and social expectations for older&#xD;
                  teens requires a more complex and flexible intervention than that proposed, and&#xD;
&#xD;
               -  Teens need to be available for 12 month follow-up sessions (our pilot studies&#xD;
                  indicated that this becomes less likely once teens are old enough to&#xD;
                  leave/graduate from high school, emancipate from parents, and/or leave home).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>School-Based Intervention</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/NCT01704768
org study id: 5R01NR012171
secondary id: 1R01NR012171-01A2
nct id: NCT01704768
lead sponsor: 
collaborator: 
has dmc: Yes
The prevention and treatment of obesity and mental health disorders in adolescence are two
      major public health problems in the United States today. To address the increasing incidence
      and adverse health outcomes associated with both obesity and mental health problems, a
      theory-based 15 session intervention program entitled COPE (Creating Opportunities for
      Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions & Exercise), will
      be delivered within high school health classes in order to improve the physical and mental
      health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).
The prevention and treatment of obesity and mental health disorders in adolescence are two
      major public health problems in the United States (U.S.) today. The incidence of adolescents
      who are overweight or obese has increased dramatically over the past 20 years, with
      approximately 17.1 percent of teens now being overweight or obese. Furthermore, approximately
      15 million children and adolescents (25 percent) in the U.S. have a mental health problem
      that is interfering with their functioning at home or at school, but less than 25 percent of
      those affected receive any treatment for these disorders. The prevalence rates of obesity and
      mental health problems are even higher in Hispanic teens, with studies suggesting that the
      two conditions often coexist in many youth. However, despite the rapidly increasing incidence
      of these two public health problems with their related health disparities and adverse health
      outcomes, there has been a paucity of theory based intervention studies conducted with
      adolescents in high schools to improve their healthy lifestyle behaviors as well as their
      physical and mental health outcomes. Unfortunately, physical and mental health services
      continue to be largely separated instead of integrated in the nation's healthcare system,
      which often leads to inadequate identification and treatment of these significant adolescent
      health problems.

      Therefore, the goal of the proposed randomized controlled trial is to test the efficacy of
      the COPE(Creating Opportunities for Personal Empowerment)/Healthy Lifestyles TEEN (Thinking,
      Feeling, Emotions & Exercise) Program, an educational and cognitive-behavioral skills
      building intervention guided by cognitive behavior theory, on the healthy lifestyle behaviors
      and depressive symptoms of 800 culturally diverse adolescents enrolled in Phoenix, Arizona
      high schools. The specific aims of the study are to: (1) Use a randomized controlled trial to
      test the short- and more long-term efficacy of the COPE TEEN Program on key outcomes,
      including healthy lifestyles behaviors, depressive symptoms and body mass index percentage,
      (2) Examine the role of cognitive beliefs and perceived difficulty in leading a healthy
      lifestyle in mediating the effects of COPE on healthy lifestyle behaviors and depressive
      symptoms; and (3) Explore variables that may moderate the effects of the intervention on
      healthy lifestyle behaviors and depressive symptoms, including race/ethnicity, gender, SES,
      acculturation, and parental healthy lifestyle beliefs and behaviors. Six prior pilot studies
      support the need for this full scale clinical trial and the use of cognitive-behavioral
      skills building in promoting healthy lifestyles beliefs, behaviors and optimal mental health
      in teens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in Body Mass Index Percentage (BMI%)
time frame: Change from Baseline to 12-Month Post intervention
description: Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
measure: Change in Healthy Lifestyle Behaviors
time frame: Change from Baseline to 12-Month Post intervention
description: Healthy lifestyle behaviors will be measured with the Healthy Lifestyle Behaviors Scale developed for use in our preliminary studies. we also will employ pedometers to objectively quantify activity. Teens will be trained in the use of the pedometer. Pedometers provide a valid and reliable means to measure habitual physical activity in youth to be used as a measure of the students Healthy Lifestyles Behaviors.
measure: Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 15-Week Post intervention
description: Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.
measure: Social Skills
time frame: 15-Week Post
description: Social Skills are measured utilizing the Social Skills Rating System (SSRS), a commercial tool that is commonly utilized in research. The SSRS is completed by the student's health teacher.
measure: Academic Performance
time frame: 15-Week Post
description: Academic performance is measured utilizing the student's health class grades
measure: Change in Body Mass Index Percentile (%)
time frame: Change from Baseline to 6-Month post intervention
description: Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
measure: Change in Healthy Lifestyle Behaviors
time frame: Change from Baseline to 6-Month Post intervention
description: Healthy lifestyle behaviors will be measured with the Healthy Lifestyle Behaviors Scale developed for use in our preliminary studies. we also will employ pedometers to objectively quantify activity. Teens will be trained in the use of the pedometer. Pedometers provide a valid and reliable means to measure habitual physical activity in youth to be used as a measure of the students Healthy Lifestyles Behaviors.
measure: Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 6-Month Post intervention
description: Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.
measure: Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 12-Month Post intervention
description: Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.
measure: Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 15-Week Post intervention
description: Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 15-Week Post intervention
description: Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
measure: Change in Triglycerides (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.
measure: Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 6-Months Post intervention
description: Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
measure: Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 12-Month Post intervention
description: Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 6-Month Post intervention
description: Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 12-Month Post intervention
description: Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
measure: Change in Total Cholesterol (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.
measure: Change in High-Density Lipoprotein (HDL)(Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).
measure: Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).
measure: Change in Triglycerides (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.
measure: Change in Total Cholesterol (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.
measure: Change in High-Density Lipoprotein (HDL) (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).
measure: Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
description: Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).
arm group label: COPE/Healthy Lifestyles TEEN Program
arm group type: Experimental
description: COPE is a manualized 15-session educational and cognitive-behavioral skills building program guided by Cognitive Behavioral Theory with physical activity as a component of each session.
arm group label: Healthy Teens Attention Control Program
arm group type: Placebo Comparator
description: Healthy Teens is an attention control program that controls for the time spent with the adolescents in the COPE group is essential to determining the efficacy of the experimental program.
intervention type: Behavioral
intervention name: COPE/Healthy Lifestyles TEEN Program.
description: The COPE Program is the intervention curriculum delivered to one arm of the study. Each session of COPE contains 15 to 20 minutes of physical activity (e.g., walking, dancing), not as an exercise training program, but rather to build beliefs/confidence in the teens that they can engage in and sustain some level of physical activity on a regular basis. Those healthy lifestyle intervention programs that have employed exercise interventions only have not led to sustained changes in healthy lifestyle behaviors. Our program is designed to enhance healthy lifestyle behaviors and sustain them because life-long cognitive-behavioral skills are taught in the program. Because the COPE TEEN program is completely manualized for the teens and instructors, it can be easily implemented by health teachers in high school settings.
arm group label: COPE/Healthy Lifestyles TEEN Program
other name: Cognitive-Behavioral Skills Building
intervention type: Behavioral
intervention name: Healthy Teens Attention Control Program
description: The Healthy Teens program is an attention control program that will assist in ruling out alternative explanations of the mechanism by which the intervention works. It will be standardized like the COPE program to insure that it can be evaluated. It will be administered in a format like that of the COPE intervention program, and will include the same number and length of sessions, except for that it will not include the theoretical active components of CBT and will not include theoretical mechanisms to produce our hypothesized changes in outcomes. Teens in the attention control group also will receive the sessions in their required health class. The difference between the two programs will lie in the content of the sessions, with the Healthy Teens program being focused on safety and common health topics/issues for teens (e.g., road safety, skin care, acne, sun safety).
arm group label: Healthy Teens Attention Control Program
other name: Educational
criteria: 
gender: All
minimum age: 14 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Sponsor