Exercise and QUality Diet After Leukemia: The EQUAL Study
1 other identifier
interventional
358
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 12, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2025
CompletedJuly 22, 2025
July 1, 2025
10.9 years
September 12, 2014
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 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.
24 months
Study Arms (2)
Intervention group
EXPERIMENTALParticipants 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 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.
Interventions
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.
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.
During three time periods, at baseline and at 12 and 24 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Johns Hopkins Universitycollaborator
- St. Jude Children's Research Hospitalcollaborator
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaya Moskowitz, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2014
First Posted
September 19, 2014
Study Start
September 1, 2014
Primary Completion
July 16, 2025
Study Completion
July 16, 2025
Last Updated
July 22, 2025
Record last verified: 2025-07