- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244411
Exercise and QUality Diet After Leukemia: The EQUAL Study
July 11, 2023 updated by: Memorial Sloan Kettering Cancer Center
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 Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
358
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Tennessee
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Memphis, Tennessee, United States
- St. Jude Children's Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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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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 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.
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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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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.
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 24 months
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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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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chaya Moskowitz, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
September 12, 2014
First Submitted That Met QC Criteria
September 16, 2014
First Posted (Estimated)
September 19, 2014
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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