Exercise and QUality Diet After Leukemia: The EQUAL Study
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ClinicalTrials.gov Identifier: NCT02244411 |
Recruitment Status :
Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : July 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Adult Survivors of Childhood Leukemia | Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins Behavioral: self directed weight loss Behavioral: questionnaires Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 358 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Exercise and QUality Diet After Leukemia: The EQUAL Study |
Actual Study Start Date : | September 2014 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
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Experimental: Intervention group
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.
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Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins
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. Behavioral: questionnaires Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months. Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure During three time periods, at baseline and at 12 and 24 months. |
Active Comparator: control group
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.
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Behavioral: self directed weight loss
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity. Behavioral: questionnaires Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months. Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure During three time periods, at baseline and at 12 and 24 months. |
- 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 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244411
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States |
Principal Investigator: | Chaya Moskowitz, PhD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT02244411 |
Other Study ID Numbers: |
14-164 |
First Posted: | September 19, 2014 Key Record Dates |
Last Update Posted: | July 12, 2022 |
Last Verified: | July 2022 |
EQUAL Exercise Diet Physical activity 14-164 |
Leukemia Neoplasms by Histologic Type Neoplasms |