Exercise and QUality Diet After Leukemia: The EQUAL Study

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Adult Survivors of Childhood Leukemia

Treatments: Behavioral: questionnaires; Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure; Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins; Behavioral: self directed weight loss

Study type: Interventional

Funder types: Other

Identifiers

NCT02244411

14-164

Details and patient eligibility

About

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.

Enrollment: 358 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins

Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure

Behavioral: questionnaires

control group

Active Comparator group

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.

Treatment:

Behavioral: self directed weight loss

Other: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure

Behavioral: questionnaires