xml: <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/NCT05963971</url>
    </required_header>
    <id_info>
      <org_study_id>AAAU5938</org_study_id>
      <secondary_id>AAAU5938</secondary_id>
      <nct_id>NCT05963971</nct_id>
    </id_info>
    <brief_title>A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors</brief_title>
    <acronym>PEDALL</acronym>
    <official_title>A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Columbia University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of this study is determine the effectiveness of a six-month virtually-delivered&#xD;
        dietary education intervention (PEDALL) on the prevention of overweight and obesity (OW/OB)&#xD;
        during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia&#xD;
        (ALL).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute lymphoblastic leukemia (ALL) has been referred to as a &quot;pre-obese state&quot;, with many&#xD;
        studies describing the onset of obesity during treatment. Weight gain typically begins within&#xD;
        the first month of ALL diagnosis, stabilizes, and then resumes at the beginning of&#xD;
        maintenance and continues into survivorship. Children and adolescents with healthy weight at&#xD;
        diagnosis are the most vulnerable to weight gain; up to 70% develop overweight/obesity&#xD;
        (OW/OB) by the end of treatment (EOT). Weight gain during treatment is one of the most&#xD;
        consistently reported risk factors for weight gain in survivorship and is associated with an&#xD;
        increased odds of being OW/OB 5-years post-EOT. Significant clinical ramifications are&#xD;
        associated with being OW/OB. A meta-analysis led by the Children's Oncology Group nutrition&#xD;
        committee found that OW/OB is associated with a 31% increased risk of mortality in ALL.&#xD;
  &#xD;
        The objective of the study team is to prevent the development of OW/OB during maintenance&#xD;
        chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in&#xD;
        English and Spanish speaking families of children and adolescents undergoing treatment for&#xD;
        ALL. Once enrolled, subjects will be randomized to PEDALL or standard of care (SOC). Subjects&#xD;
        in the PEDALL group will receive 26 contact hours of specialized nutrition education and&#xD;
        counseling via a virtual platform.&#xD;
  &#xD;
        The purpose of this study is to determine the effectiveness of a virtually-delivered dietary&#xD;
        education intervention in the prevention of OW/OB compared to SOC during maintenance&#xD;
        chemotherapy. The clinical impact of this study will improve the understanding of&#xD;
        pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight&#xD;
        gain among patients treated for ALL. Study findings may lead to the allocation of limited&#xD;
        clinical resources to individuals most susceptible to OW/OB. Information obtained from this&#xD;
        study may also direct the refinement of counseling techniques to enhance the likelihood of&#xD;
        success over the course of treatment for ALL and into survivorship. The long-term goal is to&#xD;
        enhance the likelihood of success of weight maintenance during therapy thereby mitigating&#xD;
        excess toxicities during treatment and reducing nutrition-related late-effects associated&#xD;
        with OW/OB among survivors of childhood ALL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 23, 2023</start_date>
    <completion_date type="Anticipated">June 23, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 23, 2026</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>All participants who are randomized to the intervention group will receive the same virtually-delivered nutrition educational intervention.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To prevent the development of OW/OB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL.</measure>
      <time_frame>3.5 years</time_frame>
      <description>Number of participants with overweight or obesity as assessed by body mass index (BMI) for age z-scores &gt;1 will change from baseline following 6 month virtual diet education intervention. BMI z-score will be evaluated at the end of 6-month intervention in the maintenance phase of ALL therapy. BMI z-scores will be classified by comparing age, sex, height and weight to CDC growth charts. OW is defined as BMI z-score ≥ +1.04 , and OB is defined as BMI z-score ≥ +1.645 . For participants ≥20 years of age, adult classifications will be used to determine weight status as recommended by the CDC and include BMI &lt; 19 underweight; BMI 19-&lt;25 healthy weight; BMI ≥ 25 - &lt;30 overweight; BMI ≥ 30 obese.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors.</measure>
      <time_frame>4 years</time_frame>
      <description>The proportion of OW/OB based on BMI (measured in kilograms per meters squared) at the end of treatment (EOT) for ALL and at one-year post-EOT for ALL will be analyzed as the exploratory outcomes measure of interest. The change in outcome at EOT to 1-year post EOT using a similar analytical approach to the Primary Objective will be analyzed also.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL intervention</measure>
      <time_frame>4 years</time_frame>
      <description>The modifying effect of GPS score will be calculated based on an algorithm optimized for trans-ethnic application both as a continuous variable and a dichotomized variable (&lt;median value vs ≥ median value based on PEDALL cohort), on the efficacy of PEDALL for the prevention of OW/OB at EOT and at one-year post EOT, as well as the change in outcome between the two timepoints using repeated measure ANOVA and generalized estimating equation (GEE) modeling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.</measure>
      <time_frame>4 years</time_frame>
      <description>Multi-level modeling will be used to examine the modifying effect of variables known to influence dietary behaviors on the efficacy of PEDALL for the prevention of the primary outcome. Social demographic variables to be considered for this objective are self-reported race (white vs other) and ethnicity (Hispanic vs non-Hispanic), foreign-born status (yes/no), food security (0-1 high or marginal food security vs 2-4 low food security vs 5-6 very low food security), and home food environments measured at study entry using a social demographic survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.</measure>
      <time_frame>4 years</time_frame>
      <description>Data will be collected from 24 hour diet recalls and PROMIS® survey responses and dietary and lifestyle indices will be operationalized based on the WCRF/AICR recommendations. The adapted WCRF/AICR score ranges from 0-7 and is based on 7 dietary components. Participants will receive 1 point, 0.5 points, or 0 points when the recommendation is met, partially met, or not met, respectively, within each group, with a higher score indicating greater adherence. Overall adherence scores will be analyzed by comparing the distribution of scores across arms using Wilcoxon ranked sign tests and the van Elteren test to adjust for the stratification factors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at sites</measure>
      <time_frame>4 years</time_frame>
      <description>Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa &gt;0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.</measure>
      <time_frame>4 years</time_frame>
      <description>Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa &gt;0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">376</enrollment>
    <condition>Acute Lymphoblastic Leukemia</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>PEDALL</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group (PEDALL) will receive twenty-six contact hours of virtually-delivered nutrition education. Participants and/or caregivers will meet with their nutrition educator once weekly for one hour for six months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care (SOC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects randomized to SOC will receive printed educational materials at study entry and will continue to receive nutritional education/care per their institution's standards of care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PEDALL</intervention_name>
      <description>twenty-six hour nutrition education intervention delivered virtually over a six month period</description>
      <arm_group_label>PEDALL</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of care</intervention_name>
      <description>Nutrition education per institutional standard of care</description>
      <arm_group_label>Standard of Care (SOC)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 5-21 years old at enrollment&#xD;
  &#xD;
            -  Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation&#xD;
               chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.&#xD;
  &#xD;
            -  Timing: Patient is eligible for entry only if it is feasible to start the study&#xD;
               intervention during the first month of the maintenance phase of ALL therapy.&#xD;
  &#xD;
            -  Language: Fluency in English or Spanish&#xD;
  &#xD;
            -  Weight Status: Healthy weight at baseline as determined by BMI z-score &lt; 1.04 and&#xD;
               &gt;-1.04 for those under 5-18, and BMI between 19 and 25 for those &gt;18.&#xD;
  &#xD;
            -  Ethnicity: Hispanic or Non-Hispanic of any race.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients on nutrition support (enteral or parenteral nutrition)&#xD;
  &#xD;
            -  Patients with a history of eating disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elena Ladas, PhD, RD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Columbia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Erin Corsi, RD</last_name>
      <phone>607-745-8916</phone>
      <email>ec3510@cumc.columbia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elena J. Ladas, PhD, RD</last_name>
      <phone>212-305-7835</phone>
      <email>ejd14@cumc.columbia.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Columbia University Medical Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Erin Corsi, RD</last_name>
        <phone>607-745-8916</phone>
        <email>ec3510@cumc.columbia.edu</email>
      </contact>
      <contact_backup>
        <last_name>Elena Ladas, PhD, RD</last_name>
        <phone>212-305-7835</phone>
        <email>ejd14@cumc.columbia.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Elena Ladas, PhD, RD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Justine Kahn, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Columbia University</investigator_affiliation>
      <investigator_full_name>Elena Ladas</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Acute Lymphoblastic Leukemia</keyword>
    <keyword>Obesity</keyword>
    <keyword>Childhood Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
      <mesh_term>Leukemia, Lymphoid</mesh_term>
      <mesh_term>Weight Gain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963971
  org study id: AAAU5938
  secondary id: AAAU5938
  nct id: NCT05963971
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is determine the effectiveness of a six-month virtually-delivered
        dietary education intervention (PEDALL) on the prevention of overweight and obesity (OW/OB)
        during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia
        (ALL).
  Acute lymphoblastic leukemia (ALL) has been referred to as a "pre-obese state", with many
        studies describing the onset of obesity during treatment. Weight gain typically begins within
        the first month of ALL diagnosis, stabilizes, and then resumes at the beginning of
        maintenance and continues into survivorship. Children and adolescents with healthy weight at
        diagnosis are the most vulnerable to weight gain; up to 70% develop overweight/obesity
        (OW/OB) by the end of treatment (EOT). Weight gain during treatment is one of the most
        consistently reported risk factors for weight gain in survivorship and is associated with an
        increased odds of being OW/OB 5-years post-EOT. Significant clinical ramifications are
        associated with being OW/OB. A meta-analysis led by the Children's Oncology Group nutrition
        committee found that OW/OB is associated with a 31% increased risk of mortality in ALL.
  
        The objective of the study team is to prevent the development of OW/OB during maintenance
        chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in
        English and Spanish speaking families of children and adolescents undergoing treatment for
        ALL. Once enrolled, subjects will be randomized to PEDALL or standard of care (SOC). Subjects
        in the PEDALL group will receive 26 contact hours of specialized nutrition education and
        counseling via a virtual platform.
  
        The purpose of this study is to determine the effectiveness of a virtually-delivered dietary
        education intervention in the prevention of OW/OB compared to SOC during maintenance
        chemotherapy. The clinical impact of this study will improve the understanding of
        pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight
        gain among patients treated for ALL. Study findings may lead to the allocation of limited
        clinical resources to individuals most susceptible to OW/OB. Information obtained from this
        study may also direct the refinement of counseling techniques to enhance the likelihood of
        success over the course of treatment for ALL and into survivorship. The long-term goal is to
        enhance the likelihood of success of weight maintenance during therapy thereby mitigating
        excess toxicities during treatment and reducing nutrition-related late-effects associated
        with OW/OB among survivors of childhood ALL.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: All participants who are randomized to the intervention group will receive the same virtually-delivered nutrition educational intervention.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: To prevent the development of OW/OB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL.
  time frame: 3.5 years
  description: Number of participants with overweight or obesity as assessed by body mass index (BMI) for age z-scores >1 will change from baseline following 6 month virtual diet education intervention. BMI z-score will be evaluated at the end of 6-month intervention in the maintenance phase of ALL therapy. BMI z-scores will be classified by comparing age, sex, height and weight to CDC growth charts. OW is defined as BMI z-score ≥ +1.04 , and OB is defined as BMI z-score ≥ +1.645 . For participants ≥20 years of age, adult classifications will be used to determine weight status as recommended by the CDC and include BMI < 19 underweight; BMI 19-<25 healthy weight; BMI ≥ 25 - <30 overweight; BMI ≥ 30 obese.
  measure: The effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors.
  time frame: 4 years
  description: The proportion of OW/OB based on BMI (measured in kilograms per meters squared) at the end of treatment (EOT) for ALL and at one-year post-EOT for ALL will be analyzed as the exploratory outcomes measure of interest. The change in outcome at EOT to 1-year post EOT using a similar analytical approach to the Primary Objective will be analyzed also.
  measure: The modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL intervention
  time frame: 4 years
  description: The modifying effect of GPS score will be calculated based on an algorithm optimized for trans-ethnic application both as a continuous variable and a dichotomized variable (<median value vs ≥ median value based on PEDALL cohort), on the efficacy of PEDALL for the prevention of OW/OB at EOT and at one-year post EOT, as well as the change in outcome between the two timepoints using repeated measure ANOVA and generalized estimating equation (GEE) modeling.
  measure: The modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.
  time frame: 4 years
  description: Multi-level modeling will be used to examine the modifying effect of variables known to influence dietary behaviors on the efficacy of PEDALL for the prevention of the primary outcome. Social demographic variables to be considered for this objective are self-reported race (white vs other) and ethnicity (Hispanic vs non-Hispanic), foreign-born status (yes/no), food security (0-1 high or marginal food security vs 2-4 low food security vs 5-6 very low food security), and home food environments measured at study entry using a social demographic survey.
  measure: The effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.
  time frame: 4 years
  description: Data will be collected from 24 hour diet recalls and PROMIS® survey responses and dietary and lifestyle indices will be operationalized based on the WCRF/AICR recommendations. The adapted WCRF/AICR score ranges from 0-7 and is based on 7 dietary components. Participants will receive 1 point, 0.5 points, or 0 points when the recommendation is met, partially met, or not met, respectively, within each group, with a higher score indicating greater adherence. Overall adherence scores will be analyzed by comparing the distribution of scores across arms using Wilcoxon ranked sign tests and the van Elteren test to adjust for the stratification factors.
  measure: Understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at sites
  time frame: 4 years
  description: Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa >0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.
  measure: Understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.
  time frame: 4 years
  description: Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa >0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.
  arm group label: PEDALL
  arm group type: Experimental
  description: The intervention group (PEDALL) will receive twenty-six contact hours of virtually-delivered nutrition education. Participants and/or caregivers will meet with their nutrition educator once weekly for one hour for six months.
  arm group label: Standard of Care (SOC)
  arm group type: Active Comparator
  description: Subjects randomized to SOC will receive printed educational materials at study entry and will continue to receive nutritional education/care per their institution's standards of care.
  intervention type: Behavioral
  intervention name: PEDALL
  description: twenty-six hour nutrition education intervention delivered virtually over a six month period
  arm group label: PEDALL
  intervention type: Other
  intervention name: Standard of care
  description: Nutrition education per institutional standard of care
  arm group label: Standard of Care (SOC)
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 21 Years
  healthy volunteers: No
  last name: Elena Ladas, PhD, RD
  role: Principal Investigator
  affiliation: Columbia University
  last name: Erin Corsi, RD
  phone: 607-745-8916
  email: ec3510@cumc.columbia.edu
  last name: Elena J. Ladas, PhD, RD
  phone: 212-305-7835
  email: ejd14@cumc.columbia.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Columbia University
  investigator full name: Elena Ladas
  investigator title: Principal Investigator
  mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  mesh term: Leukemia, Lymphoid
  mesh term: Weight Gain
  sharing ipd: Undecided