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Diet & Exercise Counseling for Weight Loss in Survivors of Childhood Leukemia
N/A
Waitlist Available
Led By Emily Tonorezos, MD, MPH
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with acute lymphoblastic leukemia < 18 years of age
Cancer free at time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will compare two ways of helping people who are overweight or obese lose weight.
Who is the study for?
The EQUAL study is for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are now overweight or obese. Participants must be at least 18 years old, have a BMI of 25 or higher, internet access with an email account, and be cancer-free at enrollment. They can't join if they've had total body irradiation, conditions where weight loss isn't advised, used weight loss meds recently, or have certain heart diseases.Check my eligibility
What is being tested?
This study tests whether diet and exercise guidance helps adult survivors of childhood ALL lose weight and improve health. Over two years, it compares personalized counseling with website support against self-directed weight loss efforts using questionnaires and health measurements.See study design
What are the potential side effects?
There may not be direct side effects from the interventions since they involve lifestyle changes like dieting and exercising. However, participants might experience general discomforts such as muscle soreness from new physical activities or hunger from dietary restrictions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with leukemia before turning 18.
Select...
I am currently free of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight loss
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment3 Interventions
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.
Group II: control groupActive Control3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
questionnaires
2008
Completed Phase 2
~3450
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,264 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,295 Total Patients Enrolled
St. Jude Children's Research HospitalOTHER
427 Previous Clinical Trials
5,306,219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and do not have a condition like anorexia or bulimia that affects my weight.I was diagnosed with leukemia before turning 18.I am currently free of cancer.I have undergone total body irradiation.I have not used prescription weight loss drugs in the last 6 months.I am 18 years old or older.I have a history of heart issues, including heart failure or heart attack.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this research study still available to participants?
"According to the details reported on clinicaltrials.gov, this specific medical study is no longer recruiting participants. Initially posted in September 2014 and last updated in July 2022, it has been superseded by 1411 other trials actively seeking volunteers at present."
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