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Exercise and QUality Diet After Leukemia: The EQUAL Study

Not Applicable
Completed
Conditions
Adult Survivors of Childhood Leukemia
Registration Number
NCT02244411
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
358
Inclusion Criteria

Eligibility will be confirmed via the CCSS-based medical record and by a series of questions on the EQUAL website, prior to consent.

  • Participation in the CCSS cohort
  • Diagnosed with acute lymphoblastic leukemia < 18 years of age
  • Cancer free at time of study enrollment
  • Current age ≥ 18 years
  • A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by self-reported height and weight on the most recent CCSS questionnaire
  • Internet access and a personal email account
  • Able to read and comprehend informed consent
Exclusion Criteria
  • Prior history of congestive heart failure, coronary artery disease, myocardial infarction, stroke, or unstable angina;
  • Medical condition for which weight loss might be contraindicated or which would cause weight loss, such as pregnancy, anorexia or bulimia;
  • Use of prescription weight loss medication within the previous 6 months
  • History of total body irradiation (TBI)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Weight loss24 months

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

St. Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States

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