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Adult Survivors of Childhood LeukemiaNCT02244411

Exercise and QUality Diet After Leukemia: The EQUAL Study

A study testing individual diet & physical activity counselor and website through Healthways at Hopkins, self directed weight loss and questionnaires in people with Adult Survivors of Childhood Leukemia, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Survivors of Childhood Leukemia
What is being tested?
individual diet & physical activity counselor and website through Healthways at Hopkins, self directed weight loss and questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
2 sitesUnited States
Study dates
Sep 2014to 16 Jul 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • St. Jude Children's Research Hospital

    Memphis, Tennessee

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this 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.

Being tested
individual diet & physical activity counselor and website through Healthways at Hopkins, self directed weight loss, questionnaires, fasting blood draw, measurement of height, weight and waist circumference, and blood pressure
Keywords
EQUAL, Exercise, Diet, Physical activity, 14-164
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • individual diet & physical activity counselor and website through Healthways at HopkinsBehavioural

    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 lossBehavioural

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

  • questionnairesBehavioural

    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 pressureOther

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

Study groups in NCT02244411
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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.
Receives: Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins; Behavioral: questionnaires; Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure
control groupActive comparatorParticipants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.
Receives: Behavioral: self directed weight loss; Behavioral: questionnaires; Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Loss

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion16 Jul 2025
  4. Study completion16 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02244411
Sponsor's protocol ID
14-164
Status last verified
Jul 2025
First submitted
12 Sep 2014
Last updated
24 Jul 2026

Publications

  • Friedman DN, Chou JF, Clark JM, Moskowitz CS, Ford JS, Armstrong GT, Mubdi NZ, McDonald A, Nathan PC, Sklar CA, Ramanathan LV, Robison LL, Oeffinger KC, Tonorezos ES. Exercise and QUality Diet after Leukemia: A Randomized Weight Loss Trial among Adult Survivors of Childhood Leukemia in the Childhood Cancer Survivor Study. Cancer Epidemiol Biomarkers Prev. 2024 Sep 3;33(9):1158-1166. doi: 10.1158/1055-9965.EPI-23-1601.

    PubMed 38652494

Questions about this trial

What is this clinical trial studying?

A study testing individual diet & physical activity counselor and website through Healthways at Hopkins, self directed weight loss and questionnaires in people with Adult Survivors of Childhood Leukemia, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02244411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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