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Completed

NCT Number: NCT02244411

Exercise and QUality Diet After Leukemia: The EQUAL Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

individual diet & physical activity counselor and website through Healthways at Hopkins

Behavioral

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.

self directed weight loss

Behavioral

Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.

Questionnaires

Behavioral

Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.

fasting blood draw, measurement of height, weight and waist circumference, and blood pressure

Other

During three time periods, at baseline and at 12 and 24 months.

Primary outcomes

  1. Weight Loss

    Time frame: 24 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 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Johns Hopkins University
  • St. Jude Children's Research Hospital

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2014
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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