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Exercise and QUality Diet After Leukemia: The EQUAL Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02244411
Recruitment Status : Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Johns Hopkins University
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
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

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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 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.
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.
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.




Primary Outcome Measures :
  1. 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
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)

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Johns Hopkins University
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Emily Tonorezos, MD, MPH Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02244411     History of Changes
Other Study ID Numbers: 14-164
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
EQUAL
Exercise
Diet
Physical activity
14-164

Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms