<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/NCT04453072</url>
  </required_header>
  <id_info>
    <org_study_id>19-001992</org_study_id>
    <secondary_id>NCI-2020-02687</secondary_id>
    <nct_id>NCT04453072</nct_id>
  </id_info>
  <brief_title>A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant</brief_title>
  <official_title>Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>eHealth International, INC.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This early phase I trial studies how well a behavioral weight loss intervention consisting of&#xD;
      a smartphone application and coaching works for the promotion of weight loss in adolescents&#xD;
      and young adults after a stem cell transplant. This study may help researchers learn more&#xD;
      about how adolescents and young adults can lose weight and develop healthy eating habits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as&#xD;
      a smartphone application (app) with telephone coaching, on weight outcomes of overweight and&#xD;
      obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the changes in metabolic parameters and physical activity levels, in addition&#xD;
      to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.&#xD;
&#xD;
      II. To evaluate the feasibility, adherence, and satisfaction of this intervention.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh&#xD;
      themselves and food daily. Patients interact with coaches via text messages for 4 days weekly&#xD;
      and receive weekly 15 minute phone calls for appointment reminders, emotional support,&#xD;
      progress discussion, and follow up on items discussed in a prior visit or phone call.&#xD;
      Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4&#xD;
      months to elicit both positive and negative impacts on weight management and to identify&#xD;
      barriers such as emotional eating, displacement behaviors, poor coping skills to life&#xD;
      stressors, and social challenges. Patients who opt to extend the intervention until month 12&#xD;
      attend an additional telemedicine meeting with the coach. Patients also complete&#xD;
      questionnaires over approximately 1.5 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass index (BMI) status</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: HbA1c</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: Total cholesterol</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is &lt; 170 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: Low density lipoprotein</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is &lt;100 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: High density lipoprotein</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is &gt; 45 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: triglycerides</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is &lt; 150 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: aspartate/alanine aminotransferase</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lab test analysis: glucose</measure>
    <time_frame>At four months up to 12 months</time_frame>
    <description>Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale Food Addiction Scale</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for epidemiologic studies depression scale</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress scale</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Likert Scale (0: never to 4:very often). Higher scores suggests higher stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with program</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Measured by &quot;Satisfaction Survey&quot;. This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food craving questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge eating disorder screen</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S weight</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height encounters questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Obesity</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Participate in interviews</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Media Intervention</intervention_name>
    <description>Receive iPhone with W8Loss2Go app</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete questionnaires</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scale Device</intervention_name>
    <description>Receive body scale and food scale</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
    <other_name>Scale</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive telephone calls</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text Message</intervention_name>
    <description>Receive text message</description>
    <arm_group_label>Supportive Care (app, scales, coaching, questionnaire)</arm_group_label>
    <other_name>Short Message Service (SMS) Text</other_name>
    <other_name>SMS Text Message</other_name>
    <other_name>Text</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of HSCT of any type, at least 100 days post-transplant at&#xD;
             initial consultation of the study, will be eligible for the study&#xD;
&#xD;
          -  Patients must classify as obese, represented as body mass index (BMI) &gt;= 85th&#xD;
             percentile for age and gender&#xD;
&#xD;
          -  Patients must also be able to read English since the app intervention is only&#xD;
             available in English form&#xD;
&#xD;
          -  No patients will be excluded for any specific underlying medical condition, but&#xD;
             decisions will be made on a case by case basis if a patient's functioning is deemed to&#xD;
             significantly interfere with intervention participation&#xD;
&#xD;
          -  PARENT:&#xD;
&#xD;
          -  His/her child meets all inclusion criteria&#xD;
&#xD;
          -  &gt;= 18 years of age&#xD;
&#xD;
          -  Can speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are &lt; 100 days post-transplant at initial consultation will not be&#xD;
             eligible for the study, but may become eligible if they are &gt; 100 days post-transplant&#xD;
             at their next consultation that falls within the enrollment window&#xD;
&#xD;
          -  Patients whose BMI does not fall under the obese category will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodore B Moore</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theodore B. Moore</last_name>
      <phone>310-794-8929</phone>
      <email>tbmoore@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Theodore B. Moore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Weight Loss</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/NCT04453072
org study id: 19-001992
secondary id: NCI-2020-02687
nct id: NCT04453072
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This early phase I trial studies how well a behavioral weight loss intervention consisting of
      a smartphone application and coaching works for the promotion of weight loss in adolescents
      and young adults after a stem cell transplant. This study may help researchers learn more
      about how adolescents and young adults can lose weight and develop healthy eating habits.
PRIMARY OBJECTIVE:

      I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as
      a smartphone application (app) with telephone coaching, on weight outcomes of overweight and
      obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.

      SECONDARY OBJECTIVES:

      I. To evaluate the changes in metabolic parameters and physical activity levels, in addition
      to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.

      II. To evaluate the feasibility, adherence, and satisfaction of this intervention.

      OUTLINE:

      Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh
      themselves and food daily. Patients interact with coaches via text messages for 4 days weekly
      and receive weekly 15 minute phone calls for appointment reminders, emotional support,
      progress discussion, and follow up on items discussed in a prior visit or phone call.
      Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4
      months to elicit both positive and negative impacts on weight management and to identify
      barriers such as emotional eating, displacement behaviors, poor coping skills to life
      stressors, and social challenges. Patients who opt to extend the intervention until month 12
      attend an additional telemedicine meeting with the coach. Patients also complete
      questionnaires over approximately 1.5 hours.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in body mass index (BMI) status
time frame: Baseline up to 12 months
description: The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies.
measure: Adherence
time frame: Up to 12 months
description: Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly.
measure: Fasting lab test analysis: HbA1c
time frame: At four months up to 12 months
description: HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6%
measure: Fasting lab test analysis: Total cholesterol
time frame: At four months up to 12 months
description: Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is < 170 mg/dL
measure: Fasting lab test analysis: Low density lipoprotein
time frame: At four months up to 12 months
description: LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is <100 mg/dL
measure: Fasting lab test analysis: High density lipoprotein
time frame: At four months up to 12 months
description: HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is > 45 mg/dL
measure: Fasting lab test analysis: triglycerides
time frame: At four months up to 12 months
description: TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is < 150 mg/dL
measure: Fasting lab test analysis: aspartate/alanine aminotransferase
time frame: At four months up to 12 months
description: AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L.
measure: Fasting lab test analysis: glucose
time frame: At four months up to 12 months
description: Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL
measure: Yale Food Addiction Scale
time frame: Up to 12 months
description: visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating
measure: Center for epidemiologic studies depression scale
time frame: Up to 12 months
description: 4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression
measure: Perceived stress scale
time frame: Up to 12 months
description: Likert Scale (0: never to 4:very often). Higher scores suggests higher stress
measure: Satisfaction with program
time frame: Up to 12 months
description: Measured by "Satisfaction Survey". This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention.
measure: Demographic questionnaire
time frame: Up to 12 months
description: 10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned.
measure: Food craving questionnaire
time frame: Up to 12 months
description: Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings
measure: Binge eating disorder screen
time frame: Up to 12 months
description: 4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder
measure: Physical activity questionnaire
time frame: Up to 12 months
description: participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc.
measure: S weight
time frame: Up to 12 months
description: Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight
measure: Height encounters questionnaire
time frame: Up to 12 months
description: six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned.
arm group label: Supportive Care (app, scales, coaching, questionnaire)
arm group type: Experimental
description: Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.
intervention type: Other
intervention name: Interview
description: Participate in interviews
arm group label: Supportive Care (app, scales, coaching, questionnaire)
intervention type: Other
intervention name: Media Intervention
description: Receive iPhone with W8Loss2Go app
arm group label: Supportive Care (app, scales, coaching, questionnaire)
intervention type: Other
intervention name: Questionnaire Administration
description: Complete questionnaires
arm group label: Supportive Care (app, scales, coaching, questionnaire)
intervention type: Other
intervention name: Scale Device
description: Receive body scale and food scale
arm group label: Supportive Care (app, scales, coaching, questionnaire)
other name: Scale
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive telephone calls
arm group label: Supportive Care (app, scales, coaching, questionnaire)
intervention type: Other
intervention name: Text Message
description: Receive text message
arm group label: Supportive Care (app, scales, coaching, questionnaire)
other name: Short Message Service (SMS) Text
other name: SMS Text Message
other name: Text
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Theodore B Moore
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Weight Loss