Exercise and QUality Diet After Leukemia: The EQUAL Study

Not Applicable

Active, not recruiting

• Conditions: Adult Survivors of Childhood Leukemia
• Interventions: 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

• Registration Number: NCT02244411
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 358

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	individual diet & physical activity counselor and website through Healthways at Hopkins	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.
Intervention group	questionnaires	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.
control group	self directed weight loss	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.
control group	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.
Intervention group	fasting blood draw, measurement of height, weight and waist circumference, and blood pressure	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.
control group	fasting blood draw, measurement of height, weight and waist circumference, and blood pressure	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.

Primary Outcome Measures

Name	Time	Method
Weight loss	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.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States