Adult Survivors of Childhood Leukemia
Conditions
Keywords
EQUAL, Exercise, Diet, Physical activity, 14-164
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.
Interventions
BEHAVIORALindividual 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.
BEHAVIORALself directed weight loss
Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
BEHAVIORALquestionnaires
Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.
OTHERfasting blood draw, measurement of height, weight and waist circumference, and blood pressure
During three time periods, at baseline and at 12 and 24 months.
Sponsors
Memorial Sloan Kettering Cancer Center
Johns Hopkins University
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChaya Moskowitz, PhD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 352 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 326 Participants |
| Region of Enrollment United States | 358 Participants |
| Sex: Female, Male Female | 210 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 1 / 177 |
| other Total, other adverse events | 0 / 181 | 0 / 177 |
| serious Total, serious adverse events | 0 / 181 | 1 / 177 |
Outcome results
None listed