Back to resultsExercise and QUality Diet After Leukemia: The EQUAL Study
Primary Purpose
Adult Survivors of Childhood Leukemia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional prevention trial for Adult Survivors of Childhood Leukemia focused on measuring EQUAL, Exercise, Diet, Physical activity, 14-164
Eligibility Criteria
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)
Sites / Locations
- Memorial Sloan Kettering Cancer Center
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02244411
First Posted
September 12, 2014
Last Updated
July 11, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02244411
Brief Title
Exercise and QUality Diet After Leukemia: The EQUAL Study
Official Title
Exercise and QUality Diet After Leukemia: The EQUAL Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, St. Jude Children's Research Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Survivors of Childhood Leukemia
Keywords
EQUAL, Exercise, Diet, Physical activity, 14-164
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
individual diet & physical activity counselor and website through Healthways at Hopkins
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self directed weight loss
Intervention Description
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Description
Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.
Intervention Type
Other
Intervention Name(s)
fasting blood draw, measurement of height, weight and waist circumference, and blood pressure
Intervention Description
During three time periods, at baseline and at 12 and 24 months.
Primary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaya Moskowitz, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Exercise and QUality Diet After Leukemia: The EQUAL Study
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