<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/NCT02244411</url>
  </required_header>
  <id_info>
    <org_study_id>14-164</org_study_id>
    <nct_id>NCT02244411</nct_id>
  </id_info>
  <brief_title>Exercise and QUality Diet After Leukemia: The EQUAL Study</brief_title>
  <official_title>Exercise and QUality Diet After Leukemia: The EQUAL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic&#xD;
      leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and&#xD;
      exercise can help people lose weight and improve other health problems. This two year study&#xD;
      will compare two methods of informing participants about ways to lose weight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>24 months</time_frame>
    <description>Weight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured at each time points (0, 12 months and 24 months after randomization) as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">358</enrollment>
  <condition>Adult Survivors of Childhood Leukemia</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned an individual diet &amp; physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website &amp; email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables &amp; low-fat dairy products. Calorie goals are based upon weight at study entry &amp; whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing &amp; gradually adding bouts of ≥ 10 minutes in length. Monitoring &amp; Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, &amp; physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits &amp; questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>individual diet &amp; physical activity counselor and website through Healthways at Hopkins</intervention_name>
    <description>Phone and web-based weight loss intervention (via Healthways at Hopkins counselor and website) focused on increasing physical activity and adhering to a healthy diet. Participants will log diet, physical activity, and weight in web-hub. Counselors will have access to this information to direct participants to goals and achievements.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self directed weight loss</intervention_name>
    <description>Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <description>Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fasting blood draw, measurement of height, weight and waist circumference, and blood pressure</intervention_name>
    <description>During three time periods, at baseline and at 12 and 24 months.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligibility will be confirmed via the CCSS-based medical record and by a series of&#xD;
        questions on the EQUAL website, prior to consent.&#xD;
&#xD;
          -  Participation in the CCSS cohort&#xD;
&#xD;
          -  Diagnosed with acute lymphoblastic leukemia &lt; 18 years of age&#xD;
&#xD;
          -  Cancer free at time of study enrollment&#xD;
&#xD;
          -  Current age ≥ 18 years&#xD;
&#xD;
          -  A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by&#xD;
             self-reported height and weight on the most recent CCSS questionnaire&#xD;
&#xD;
          -  Internet access and a personal email account&#xD;
&#xD;
          -  Able to read and comprehend informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of congestive heart failure, coronary artery disease, myocardial&#xD;
             infarction, stroke, or unstable angina;&#xD;
&#xD;
          -  Medical condition for which weight loss might be contraindicated or which would cause&#xD;
             weight loss, such as pregnancy, anorexia or bulimia;&#xD;
&#xD;
          -  Use of prescription weight loss medication within the previous 6 months&#xD;
&#xD;
          -  History of total body irradiation (TBI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chaya Moskowitz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EQUAL</keyword>
  <keyword>Exercise</keyword>
  <keyword>Diet</keyword>
  <keyword>Physical activity</keyword>
  <keyword>14-164</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</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/NCT02244411
org study id: 14-164
nct id: NCT02244411
lead sponsor: 
collaborator: 
collaborator: 
The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic
      leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and
      exercise can help people lose weight and improve other health problems. This two year study
      will compare two methods of informing participants about ways to lose weight.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Weight loss
time frame: 24 months
description: Weight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured at each time points (0, 12 months and 24 months after randomization) as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm.
arm group label: Intervention group
arm group type: Experimental
description: Participants will be assigned an individual diet & physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website & email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables & low-fat dairy products. Calorie goals are based upon weight at study entry & whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing & gradually adding bouts of ≥ 10 minutes in length. Monitoring & Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, & physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits & questionnaires.
arm group label: control group
arm group type: Active Comparator
description: Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.
intervention type: Behavioral
intervention name: individual diet & physical activity counselor and website through Healthways at Hopkins
description: Phone and web-based weight loss intervention (via Healthways at Hopkins counselor and website) focused on increasing physical activity and adhering to a healthy diet. Participants will log diet, physical activity, and weight in web-hub. Counselors will have access to this information to direct participants to goals and achievements.
arm group label: Intervention group
intervention type: Behavioral
intervention name: self directed weight loss
description: Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
arm group label: control group
intervention type: Behavioral
intervention name: questionnaires
description: Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.
arm group label: Intervention group
arm group label: control group
intervention type: Other
intervention name: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure
description: During three time periods, at baseline and at 12 and 24 months.
arm group label: Intervention group
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chaya Moskowitz, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Leukemia