<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/NCT01700309</url>
  </required_header>
  <id_info>
    <org_study_id>2010/2978</org_study_id>
    <nct_id>NCT01700309</nct_id>
  </id_info>
  <brief_title>Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents.</brief_title>
  <acronym>YFH</acronym>
  <official_title>Young Fit and Happy - Meaningful Physical Activity as Means to Improve Quality of Life and Prevent Weight Gain in Over-weight and Obese Adolescents. A Web-based Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen&#xD;
      as one of the most important public health threats because of the significant impact of&#xD;
      chronic conditions associated with obesity. Obesity during adolescence is a strong precursor&#xD;
      of obesity and related morbidity in adulthood.&#xD;
&#xD;
      Interventions aimed directly at reducing weight or preventing increase in weight shows&#xD;
      limited results on long term effects and it is shown that increase in activity has more&#xD;
      impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an&#xD;
      appropriate measure of therapeutic interventions for growing children. The hypothesis of this&#xD;
      study is that focusing on increasing meaningful physical activity through individual tailored&#xD;
      counselling will have positive effects on the adolescents' fitness (health) and quality of&#xD;
      life. Thus, the overall purpose of the study is to examine the extent to which a web-based&#xD;
      intervention influences physical activity, fitness and quality of life in over-weight and&#xD;
      obese adolescents Further, the aim is to explore and describe how adolescents experience&#xD;
      being over-weight and obese, what they perceive as meaningful physical activity and finally&#xD;
      how adolescents experience lifestyle changes as demanded in the intervention study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The target group is overweight adolescents, meaning their BMI is over or equal to the 95th&#xD;
      percentile (BMI&gt;25) and they should not have severe health problems as a result of their&#xD;
      overweight. For adults, BMI (Body Mass Index; weight in kilograms divided by the square of&#xD;
      height in meters) values at or above 25 indicate overweight and a BMI at or above 30 defines&#xD;
      obesity. No such generally accepted definitions exist for children and adolescents. However,&#xD;
      international standardized cut points have been proposed, among others by Cole et al (2000)&#xD;
      and experts support the use of BMI cutoff points for children. The cut points proposed by&#xD;
      Cole et al (2000) are widely used and take age, gender and sex into consideration in the&#xD;
      estimation. The focus is primarily to prevent a negative development, and the aim is that the&#xD;
      school health service in the future might implement a modified version of this strategy for&#xD;
      working with overweight adolescents.&#xD;
&#xD;
      The design of the study is a complex intervention study with a multi-method design,&#xD;
      consisting of a quasi-experimental trial and a qualitative study. The sample will be drawn&#xD;
      from schools in Oslo. Overweight adolescents will be selected and placed in the intervention&#xD;
      group or control group respectively. The sampling will be based on objective measures of&#xD;
      weight and height and using Cole's index to define overweight and obesity. Weight and height&#xD;
      will be measured by the school nurse and will be coordinated with her regular meetings with&#xD;
      the adolescents in 8th grade.. The study group will receive the web-based intervention and&#xD;
      the control group will receive standard care. At baseline, 3 months and 1 year both the&#xD;
      experimental group and the control group will be measured at relevant variables. In the&#xD;
      qualitative part of the study, in depth interviews with the adolescents in the intervention&#xD;
      group will be performed and they will write daily unstructured blogs on the web. The sampling&#xD;
      procedure for the qualitative part of the study will follow the sampling procedure of the&#xD;
      intervention study. From the intervention group, a strategic or purposive sample of&#xD;
      adolescents will be asked to participate in the qualitative part (Gerrish and Lacey 2006). A&#xD;
      sample of maximum variation according to gender and sosio-demographic variables is intended.&#xD;
      Sampling continues until saturation is reached and the adolescents will be interviewed in&#xD;
      depth before the intervention starts, further at 3 and 12 months after the intervention is&#xD;
      ended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fitness</measure>
    <time_frame>One year</time_frame>
    <description>It Hypothesised that weekly individual web-counseling will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness.&#xD;
Fitness is measured with a maximal multistage 20 m shuttle run test (Leger et al., 1988)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>one year</time_frame>
    <description>It is our assumption that weekly individual web-counseling, based on theories of coping and motivation, will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness (health) and their quality of life.&#xD;
Measured with Kidscreen 52.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Motivation for Physical activity and exercise, BMI, Self-efficacy</measure>
    <time_frame>One Year</time_frame>
    <description>Motivation for Physical activity and exercise measured by the Behavioural Regulation In Exercise Questionnaire (BREQ2). BMI is calculated based on objective measures of height and weight. Self-efficacy is measured with Schwarzer 8 item questionaire.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young and Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will recieve web-based health counselling through the web-site Young and Active.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Young and Active</intervention_name>
    <description>The intervention will consist of three meetings between the adolescent, the parents and the researchers, and weekly web-based health-counselling. The adolescents will set goals and make an individual activity plan on the web-page. During the study period all activity will be registered by the adolescents. The researchers will perform weekly counseling based on Selfdetermination Theory and Motivational Interviewing. The webiste also allows for the adolescents to communicate with eacother and with the counsler through a blog.</description>
    <arm_group_label>Young and Active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  overweight/obese adolescents in 8th grade&#xD;
&#xD;
          -  BMI is over or equal to the 95th percentile (BMI&gt;25 according to Cole's index)(height&#xD;
             and weight measured by the school nurse)&#xD;
&#xD;
          -  school population&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  not have severe health problems as a result of their overweight&#xD;
&#xD;
          -  not be in another treatment program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sølvi Helseth, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo Metropolitan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo and Akershus University College</name>
      <address>
        <city>Oslo</city>
        <zip>0130</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwegian School of Sport Sciences</name>
      <address>
        <city>Oslo</city>
        <zip>0806</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>April 14, 2015</last_update_submitted>
  <last_update_submitted_qc>April 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo Metropolitan University</investigator_affiliation>
    <investigator_full_name>Sølvi Helseth</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity prevention; Adolescent; Physical activity; Health counselling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT01700309
org study id: 2010/2978
nct id: NCT01700309
lead sponsor: 
collaborator: 
has dmc: No
The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen
      as one of the most important public health threats because of the significant impact of
      chronic conditions associated with obesity. Obesity during adolescence is a strong precursor
      of obesity and related morbidity in adulthood.

      Interventions aimed directly at reducing weight or preventing increase in weight shows
      limited results on long term effects and it is shown that increase in activity has more
      impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an
      appropriate measure of therapeutic interventions for growing children. The hypothesis of this
      study is that focusing on increasing meaningful physical activity through individual tailored
      counselling will have positive effects on the adolescents' fitness (health) and quality of
      life. Thus, the overall purpose of the study is to examine the extent to which a web-based
      intervention influences physical activity, fitness and quality of life in over-weight and
      obese adolescents Further, the aim is to explore and describe how adolescents experience
      being over-weight and obese, what they perceive as meaningful physical activity and finally
      how adolescents experience lifestyle changes as demanded in the intervention study.
The target group is overweight adolescents, meaning their BMI is over or equal to the 95th
      percentile (BMI>25) and they should not have severe health problems as a result of their
      overweight. For adults, BMI (Body Mass Index; weight in kilograms divided by the square of
      height in meters) values at or above 25 indicate overweight and a BMI at or above 30 defines
      obesity. No such generally accepted definitions exist for children and adolescents. However,
      international standardized cut points have been proposed, among others by Cole et al (2000)
      and experts support the use of BMI cutoff points for children. The cut points proposed by
      Cole et al (2000) are widely used and take age, gender and sex into consideration in the
      estimation. The focus is primarily to prevent a negative development, and the aim is that the
      school health service in the future might implement a modified version of this strategy for
      working with overweight adolescents.

      The design of the study is a complex intervention study with a multi-method design,
      consisting of a quasi-experimental trial and a qualitative study. The sample will be drawn
      from schools in Oslo. Overweight adolescents will be selected and placed in the intervention
      group or control group respectively. The sampling will be based on objective measures of
      weight and height and using Cole's index to define overweight and obesity. Weight and height
      will be measured by the school nurse and will be coordinated with her regular meetings with
      the adolescents in 8th grade.. The study group will receive the web-based intervention and
      the control group will receive standard care. At baseline, 3 months and 1 year both the
      experimental group and the control group will be measured at relevant variables. In the
      qualitative part of the study, in depth interviews with the adolescents in the intervention
      group will be performed and they will write daily unstructured blogs on the web. The sampling
      procedure for the qualitative part of the study will follow the sampling procedure of the
      intervention study. From the intervention group, a strategic or purposive sample of
      adolescents will be asked to participate in the qualitative part (Gerrish and Lacey 2006). A
      sample of maximum variation according to gender and sosio-demographic variables is intended.
      Sampling continues until saturation is reached and the adolescents will be interviewed in
      depth before the intervention starts, further at 3 and 12 months after the intervention is
      ended.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fitness
time frame: One year
description: It Hypothesised that weekly individual web-counseling will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness.
Fitness is measured with a maximal multistage 20 m shuttle run test (Leger et al., 1988)
measure: Quality of Life
time frame: one year
description: It is our assumption that weekly individual web-counseling, based on theories of coping and motivation, will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness (health) and their quality of life.
Measured with Kidscreen 52.
measure: Motivation for Physical activity and exercise, BMI, Self-efficacy
time frame: One Year
description: Motivation for Physical activity and exercise measured by the Behavioural Regulation In Exercise Questionnaire (BREQ2). BMI is calculated based on objective measures of height and weight. Self-efficacy is measured with Schwarzer 8 item questionaire.
arm group label: Control group
arm group type: No Intervention
description: Treatment as usual
arm group label: Young and Active
arm group type: Experimental
description: This arm will recieve web-based health counselling through the web-site Young and Active.
intervention type: Behavioral
intervention name: Young and Active
description: The intervention will consist of three meetings between the adolescent, the parents and the researchers, and weekly web-based health-counselling. The adolescents will set goals and make an individual activity plan on the web-page. During the study period all activity will be registered by the adolescents. The researchers will perform weekly counseling based on Selfdetermination Theory and Motivational Interviewing. The webiste also allows for the adolescents to communicate with eacother and with the counsler through a blog.
arm group label: Young and Active
criteria: 
gender: All
minimum age: 12 Years
maximum age: 14 Years
healthy volunteers: No
last name: Sølvi Helseth, PhD
role: Principal Investigator
affiliation: Oslo Metropolitan University
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo Metropolitan University
investigator full name: Sølvi Helseth
investigator title: Professor
mesh term: Obesity
mesh term: Overweight