<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/NCT03776552</url>
  </required_header>
  <id_info>
    <org_study_id>GoLow</org_study_id>
    <nct_id>NCT03776552</nct_id>
  </id_info>
  <brief_title>Effectiveness of Gradual Versus Rapid Weight Loss</brief_title>
  <acronym>GoLow</acronym>
  <official_title>Comparative Effectiveness of a Gradual Weight Loss Program and a Rapid Weight Loss Program (Including a Low Energy Diet) on 1-year Weight Loss in Subjects With Obesity - A Randomized, Parallel-group, Superiority Trial. (The GoLow Study).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital of Vestfold</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roede AS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital of Vestfold</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid&#xD;
      weight loss (RWL) program and a gradual weight loss (GWL) program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of at least 286 participants will be randomized to either a 16-week rapid weight loss&#xD;
      (RWL) program; [an 8-week low-energy-diet (&lt;1000 kcal/day) - followed by an 8-week gradual&#xD;
      increase in energy intake (4 weeks &lt;1300 kcal/day and 4 weeks &lt;1500 kcal/day)], or a 16-week&#xD;
      gradual weight loss (GWL) program (controls); [estimated total energy expenditure minus&#xD;
      800-1000 kcal/day]. Thereafter, all participants (both groups) will undergo a 36-week&#xD;
      comprehensive weight maintenance program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Actual">September 16, 2021</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>
    <intervention_model_description>Randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor was masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight from baseline to 12 months</measure>
    <time_frame>Baseline to 1-year</time_frame>
    <description>Percent total body weight loss (%TBWL) at 12 months follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in anthropometric measures</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Waist and hip circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition 1</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition 2</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Dual-energy X-ray Absorptiometry (DXA) in selected participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipids</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Systolic and diastolic blood pressure (mm/Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glucose parameters</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>HbA1c (mmol/mol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CRP</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>CRP (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Health Related Quality of Life 1</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Generic questionnaire: Short Form-36 Health Survey, SF36. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Health Related Quality of Life 2</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Obesity specific questionnaire: IWQOL-lite. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Health Related Quality of Life 3</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero (&quot;not at all&quot;) to six (&quot;bothers a very great deal&quot;). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in symptoms of depression and anxiety</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in eating behavior</measure>
    <time_frame>4-month and 1-year</time_frame>
    <description>The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight from baseline to 4 months</measure>
    <time_frame>4-month</time_frame>
    <description>Percent total body weight loss (%TBWL) at 4 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week</measure>
    <time_frame>1-year</time_frame>
    <description>TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">293</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Rapid weight loss (RWL) program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16-week rapid weight loss (RWL) program [8-week LED (&lt;1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks &lt;1300 kcal/day and 4 weeks &lt;1500 kcal/day)] followed by a 36-weight loss maintenance program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gradual weight loss (GWL) program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rapid weight loss (RWL) program</intervention_name>
    <description>16-week rapid weight loss (RWL) program (8-week low energy diet (LED) followed by 8-week gradual increased energy intake) and a subsequent 36-week weight-maintenance follow-up</description>
    <arm_group_label>Rapid weight loss (RWL) program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gradual weight loss (GWL) program</intervention_name>
    <description>16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up</description>
    <arm_group_label>Gradual weight loss (GWL) program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Willing and able to give informed consent for participation in the study&#xD;
&#xD;
               -  Living in the eastern part of Norway, mainly Oslo, Buskerud, Vestfold and&#xD;
                  Akershus&#xD;
&#xD;
               -  Understanding Norwegian language written and spoken easily&#xD;
&#xD;
               -  BMI ≥30.0 kg/m2&#xD;
&#xD;
               -  Stable body weight (&lt;5 kg self-reported weight change) during the last 3 months&#xD;
                  before inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnancy and breast-feeding mothers&#xD;
&#xD;
               -  Suspected non-compliance with regards to visits and/or diet&#xD;
&#xD;
               -  Severe chronic disease (endocrine disease, heart disease, neurological disease,&#xD;
                  lung disease, disease in the gastrointestinal tract, kidney disease, rheumatism&#xD;
                  or cancer).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jøran Hjelmesæth, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital of Vestfold</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vestfold Hospital Trust</name>
      <address>
        <city>Tønsberg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital of Vestfold</investigator_affiliation>
    <investigator_full_name>Jøran Hjelmesæth</investigator_full_name>
    <investigator_title>Professor, Head</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776552
org study id: GoLow
nct id: NCT03776552
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid
      weight loss (RWL) program and a gradual weight loss (GWL) program.
A total of at least 286 participants will be randomized to either a 16-week rapid weight loss
      (RWL) program; [an 8-week low-energy-diet (<1000 kcal/day) - followed by an 8-week gradual
      increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)], or a 16-week
      gradual weight loss (GWL) program (controls); [estimated total energy expenditure minus
      800-1000 kcal/day]. Thereafter, all participants (both groups) will undergo a 36-week
      comprehensive weight maintenance program.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessor was masked
measure: Change in body weight from baseline to 12 months
time frame: Baseline to 1-year
description: Percent total body weight loss (%TBWL) at 12 months follow-up
measure: Changes in anthropometric measures
time frame: 4-month and 1-year
description: Waist and hip circumference (cm)
measure: Changes in body composition 1
time frame: 4-month and 1-year
description: Bioelectrical Impedance Analysis (BIA)
measure: Changes in body composition 2
time frame: 4-month and 1-year
description: Dual-energy X-ray Absorptiometry (DXA) in selected participants
measure: Changes in lipids
time frame: 4-month and 1-year
description: Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l)
measure: Changes in blood pressure
time frame: 4-month and 1-year
description: Systolic and diastolic blood pressure (mm/Hg)
measure: Changes in glucose parameters
time frame: 4-month and 1-year
description: HbA1c (mmol/mol)
measure: Changes in CRP
time frame: 4-month and 1-year
description: CRP (mg/L)
measure: Changes in Health Related Quality of Life 1
time frame: 4-month and 1-year
description: Generic questionnaire: Short Form-36 Health Survey, SF36. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated
measure: Changes in Health Related Quality of Life 2
time frame: 4-month and 1-year
description: Obesity specific questionnaire: IWQOL-lite. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.
measure: Changes in Health Related Quality of Life 3
time frame: 4-month and 1-year
description: Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero ("not at all") to six ("bothers a very great deal"). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120.
measure: Changes in symptoms of depression and anxiety
time frame: 4-month and 1-year
description: Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21.
measure: Changes in eating behavior
time frame: 4-month and 1-year
description: The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating.
measure: Change in weight from baseline to 4 months
time frame: 4-month
description: Percent total body weight loss (%TBWL) at 4 months follow-up
measure: Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
time frame: 1-year
description: TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up
arm group label: Rapid weight loss (RWL) program
arm group type: Active Comparator
description: 16-week rapid weight loss (RWL) program [8-week LED (<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)] followed by a 36-weight loss maintenance program.
arm group label: Gradual weight loss (GWL) program
arm group type: Active Comparator
description: 16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.
intervention type: Other
intervention name: Rapid weight loss (RWL) program
description: 16-week rapid weight loss (RWL) program (8-week low energy diet (LED) followed by 8-week gradual increased energy intake) and a subsequent 36-week weight-maintenance follow-up
arm group label: Rapid weight loss (RWL) program
intervention type: Other
intervention name: Gradual weight loss (GWL) program
description: 16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up
arm group label: Gradual weight loss (GWL) program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jøran Hjelmesæth, Professor
role: Principal Investigator
affiliation: The Hospital of Vestfold
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: The Hospital of Vestfold
investigator full name: Jøran Hjelmesæth
investigator title: Professor, Head
mesh term: Obesity
mesh term: Weight Loss
sharing ipd: No