<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/NCT01675713</url>
  </required_header>
  <id_info>
    <org_study_id>KKD1</org_study_id>
    <nct_id>NCT01675713</nct_id>
  </id_info>
  <brief_title>Lifestyleintervention for the Treatment of Severe Obesity</brief_title>
  <official_title>Intensive Lifestyleintervention for the Treatment of Severe Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hjelp24</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian School of Sport Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (&gt; 1&#xD;
      year) term effects on body composition and psychological health after a 10 to 14-weeks&#xD;
      comprehensive lifestyle modification program for the treatment of severe obesity.&#xD;
&#xD;
      The aims of the PhD project are to investigate whether an intensive lifestyle intervention&#xD;
      leads to acute and short term (&lt; 1 year) changes in:&#xD;
&#xD;
        1. The BMI/Weight&#xD;
&#xD;
        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and&#xD;
           visceral fat area)&#xD;
&#xD;
        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and&#xD;
           health-related quality of life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity&#xD;
      Clinic, which is an inpatient program to address morbid obesity in adults. The study is a&#xD;
      non-randomized clinical trial comparing the acute and long-term effects on physical and&#xD;
      psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification&#xD;
      program for the treatment of morbidly obese patients.&#xD;
&#xD;
      In between the inpatient stay, the patients are followed up either by telephone, occasional&#xD;
      mail and/or structured / weekly email.&#xD;
&#xD;
      In this project we prospectively follow two groups of patient included in the treatment&#xD;
      programme in September 2010 and January 2011, respectively. In addition a control group with&#xD;
      waiting-list patients is also included in the study, and they were recruited in&#xD;
      October-November 2011&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in Health related quality of life from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in Health related quality of life from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in Health related quality of life from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge Eating</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in binge eating from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge eating</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in binge eating from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge eating</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in binge eating from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in anxiety from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in depression from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in depression from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in depression from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in physical activity from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in physical activity from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in physical activity from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in physical fitness from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in physical fitness from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in physical fitness from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in Systolic Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in Systolic Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in Systolic Blood Pressure from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>Week 10-14</time_frame>
    <description>Change in glucose from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>Week 26</time_frame>
    <description>Change in glucose from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>Week 52</time_frame>
    <description>Change in glucose from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore the participants experiences with physical activity prior to, during and after the treatment programme</measure>
    <time_frame>2-3 years post treatment</time_frame>
    <description>In depth interviews</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10-14 weeks intensive lifestyle intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment, waiting list</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive lifestyle intervention</intervention_name>
    <description>Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies</description>
    <arm_group_label>Lifestyle intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  morbidly obese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not able to walk slowly for 20 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sverre Mæhlum, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hjelp24</affiliation>
  </overall_official>
  <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>
  <reference>
    <citation>Maehlum S, Danielsen KK, Heggebo LK, Schioll J. The Hjelp24 NIMI Ringerike obesity clinic: an inpatient programme to address morbid obesity in adults. Br J Sports Med. 2012 Feb;46(2):91-4. doi: 10.1136/bjsm.2010.071894. Epub 2010 May 10.</citation>
    <PMID>20460258</PMID>
  </reference>
  <results_reference>
    <citation>Danielsen KK, Sundgot-Borgen J, Maehlum S, Svendsen M. Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Ann Med. 2014 Aug;46(5):273-82. doi: 10.3109/07853890.2013.874660. Epub 2014 Feb 4. Erratum In: Ann Med. 2014 Nov;46(7):566.</citation>
    <PMID>24491067</PMID>
  </results_reference>
  <results_reference>
    <citation>Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.</citation>
    <PMID>23710347</PMID>
  </results_reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 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>Norwegian School of Sport Sciences</investigator_affiliation>
    <investigator_full_name>Professor Jorunn Sundgot-Borgen</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <keyword>Lifestyle</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</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/NCT01675713
org study id: KKD1
nct id: NCT01675713
lead sponsor: 
collaborator: 
has dmc: Yes
The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1
      year) term effects on body composition and psychological health after a 10 to 14-weeks
      comprehensive lifestyle modification program for the treatment of severe obesity.

      The aims of the PhD project are to investigate whether an intensive lifestyle intervention
      leads to acute and short term (< 1 year) changes in:

        1. The BMI/Weight

        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and
           visceral fat area)

        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and
           health-related quality of life
The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity
      Clinic, which is an inpatient program to address morbid obesity in adults. The study is a
      non-randomized clinical trial comparing the acute and long-term effects on physical and
      psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification
      program for the treatment of morbidly obese patients.

      In between the inpatient stay, the patients are followed up either by telephone, occasional
      mail and/or structured / weekly email.

      In this project we prospectively follow two groups of patient included in the treatment
      programme in September 2010 and January 2011, respectively. In addition a control group with
      waiting-list patients is also included in the study, and they were recruited in
      October-November 2011
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health
time frame: three years
measure: Body composition
time frame: Week 10-14
description: Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
measure: Body composition
time frame: Week 26
description: Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
measure: Body composition
time frame: Week 52
description: Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
measure: Health related quality of life
time frame: Week 10-14
description: Change in Health related quality of life from baseline
measure: Health related quality of life
time frame: Week 26
description: Change in Health related quality of life from baseline
measure: Health related quality of life
time frame: Week 52
description: Change in Health related quality of life from baseline
measure: Binge Eating
time frame: Week 10-14
description: Change in binge eating from baseline
measure: Binge eating
time frame: Week 26
description: Change in binge eating from baseline
measure: Binge eating
time frame: Week 52
description: Change in binge eating from baseline
measure: Anxiety
time frame: Week 10-14
description: Change in anxiety from baseline
measure: Depression
time frame: Week 10-14
description: Change in depression from baseline
measure: Depression
time frame: Week 26
description: Change in depression from baseline
measure: Depression
time frame: Week 52
description: Change in depression from baseline
measure: Physical Activity
time frame: Week 10-14
description: Change in physical activity from baseline
measure: Physical activity
time frame: Week 26
description: Change in physical activity from baseline
measure: Physical activity
time frame: Week 52
description: Change in physical activity from baseline
measure: Physical fitness
time frame: Week 10-14
description: Change in physical fitness from baseline
measure: Physical fitness
time frame: Week 26
description: Change in physical fitness from baseline
measure: Physical fitness
time frame: Week 52
description: Change in physical fitness from baseline
measure: Systolic Blood Pressure
time frame: Week 10-14
description: Change in Systolic Blood Pressure
measure: Systolic Blood Pressure
time frame: Week 26
description: Change in Systolic Blood Pressure
measure: Systolic Blood Pressure
time frame: Week 52
description: Change in Systolic Blood Pressure from baseline
measure: Lipids
time frame: Week 10-14
description: Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
measure: Lipids
time frame: Week 26
description: Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
measure: Lipids
time frame: Week 52
description: Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
measure: Glucose
time frame: Week 10-14
description: Change in glucose from baseline
measure: Glucose
time frame: Week 26
description: Change in glucose from baseline
measure: Glucose
time frame: Week 52
description: Change in glucose from baseline
measure: Explore the participants experiences with physical activity prior to, during and after the treatment programme
time frame: 2-3 years post treatment
description: In depth interviews
arm group label: Lifestyle intervention
arm group type: Experimental
description: 10-14 weeks intensive lifestyle intervention
arm group label: Controls
arm group type: No Intervention
description: No treatment, waiting list
intervention type: Behavioral
intervention name: Intensive lifestyle intervention
description: Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies
arm group label: Lifestyle intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sverre Mæhlum, MD, PhD
role: Study Director
affiliation: Hjelp24
facility: 
country: Norway
citation: Maehlum S, Danielsen KK, Heggebo LK, Schioll J. The Hjelp24 NIMI Ringerike obesity clinic: an inpatient programme to address morbid obesity in adults. Br J Sports Med. 2012 Feb;46(2):91-4. doi: 10.1136/bjsm.2010.071894. Epub 2010 May 10.
PMID: 20460258
citation: Danielsen KK, Sundgot-Borgen J, Maehlum S, Svendsen M. Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Ann Med. 2014 Aug;46(5):273-82. doi: 10.3109/07853890.2013.874660. Epub 2014 Feb 4. Erratum In: Ann Med. 2014 Nov;46(7):566.
PMID: 24491067
citation: Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.
PMID: 23710347
responsible party type: Principal Investigator
investigator affiliation: Norwegian School of Sport Sciences
investigator full name: Professor Jorunn Sundgot-Borgen
investigator title: Professor, PhD
mesh term: Obesity
mesh term: Obesity, Morbid