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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Adult Survivors of Childhood Leukemia
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. 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 group | Active comparator | 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. 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.
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.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Survivors of Childhood LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaya Moskowitz, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
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
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and QUality Diet After Leukemia: The EQUAL Study
- ClinicalTrials.gov ID
- NCT02244411
- Acronym / sponsor ID
- 14-164
- Conditions
- Adult Survivors of Childhood Leukemia
- Keywords
- EQUAL, Exercise, Diet, Physical activity, 14-164
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, St. Jude Children's Research Hospital
- Study start
- Sep 2014 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | 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 pressureParticipants 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. |
| control group | Active comparator | Behavioral: self directed weight loss, Behavioral: questionnaires, Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressureParticipants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual diet & physical activity counselor and website through Healthways at HopkinsPhone 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. | Behavioural | Intervention group |
| self directed weight lossParticipants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity. | Behavioural | control group |
| questionnairesParticipants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months. | Behavioural | Intervention group, control group |
| fasting blood draw, measurement of height, weight and waist circumference, and blood pressureDuring three time periods, at baseline and at 12 and 24 months. | Other | Intervention group, control group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38652494Friedman 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Active, not recruitingObservational study
A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Acute Lymphoblastic Leukemia, Brain Tumor
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Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae
Childhood Non-Hodgkin Lymphoma, Childhood Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaya Moskowitz, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
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.