Exercise and QUality Diet After Leukemia: The EQUAL Study

NCT ID: NCT02244411

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2025-07-16

Brief Summary

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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

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Conditions

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Adult Survivors of Childhood Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

questionnaires

Intervention Type BEHAVIORAL

Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.

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

Intervention Type OTHER

During three time periods, at baseline and at 12 and 24 months.

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.

Group Type ACTIVE_COMPARATOR

self directed weight loss

Intervention Type BEHAVIORAL

Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.

questionnaires

Intervention Type BEHAVIORAL

Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.

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

Intervention Type OTHER

During three time periods, at baseline and at 12 and 24 months.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chaya Moskowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-164

Identifier Type: -

Identifier Source: org_study_id

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