Exercise and QUality Diet After Leukemia: The EQUAL Study

Adult Survivors of Childhood Leukemia Clinical Trial

Official title:

Exercise and QUality Diet After Leukemia: The EQUAL Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02244411
• Other study ID #: 14-164
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adult Survivors of Childhood Leukemia
• Leukemia

Intervention

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.
• self directed weight loss
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Johns Hopkins University, St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center