| Registry | NCT02244411 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 358 (Actual) |
| Sponsor | Memorial Sloan Kettering Cancer Center (Other); collaborators: Johns Hopkins University, St. Jude Children's Research Hospital |
| Conditions | Adult Survivors of Childhood Leukemia |
| Interventions | individual diet & physical activity counselor and website through Healthways at Hopkins, self directed weight loss, questionnaires, fasting blood draw, measurement of height, weight and waist circumference, and blood pressure (Behavioral, other) |
| Dates | start 2014-09-01, primary completion 2025-07-16, completion 2025-07-16, first posted 2014-09-19, last updated 2026-07-24 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Adult Survivors of Childhood Leukemia All trials of individual diet & physical activity counselor and website through Healthways at Hopkins All trials of self directed weight loss
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group | Experimental | Behavioral: individual diet & physical activity counselor and website through Healthways at Hopkins; Behavioral: questionnaires; Other: 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 | Active comparator | Behavioral: self directed weight loss; Behavioral: questionnaires; Other: 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. |
Sex: All, ages: 18 Years to any
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)
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 181 | 177 |
| Completed | 165 | 170 |
| Not completed | 16 | 7 |
Time frame: 24 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Intervention Group | 0/181 (0.0%) | 0/181 (0.0%) | 0/181 (0.0%) |
| Control Group | 1/177 (0.6%) | 1/177 (0.6%) | 0/177 (0.0%) |
| Term | Organ system | Intervention Group | Control Group |
|---|---|---|---|
| Death NOS | General disorders | 0/181 | 1/177 |
| Facility | City | Country | Status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York | United States | |
| St. Jude Children's Research Hospital | Memphis, Tennessee | United States |