Exercise and QUality diet After Leukemia (The EQUAL Study): An intervention trial in the Childhood Cancer Survivor Study (CCSS)

10015 Background: Survivors of childhood acute lymphoblastic leukemia (ALL) are at risk for obesity and cardiovascular (CV) disease. Exposure to cranial radiotherapy (CRT) increases risks. We tested whether a weight loss intervention that was successful in the general population could result in weight loss or improvements CV risk factors for ALL survivors. Methods: Obese and overweight 5-year ALL survivors diagnosed < age 21 from CCSS were randomized to a 24-month remotely delivered diet/physical activity intervention or self-directed weight loss (control), stratified by CRT. The intervention emphasized a low calorie DASH diet and physical activity via an app, a website, and weekly coach calls. The primary endpoint was difference in weight loss after 24 months, using an intent-to-treat analysis. Secondary endpoints: differences in changes in blood pressure, cholesterol, and triglycerides. Analyses were performed using linear mixed effects; the study was designed to detect a difference of 2.75 kg. Results: Of 358 survivors (59% female, 91% White non-Hispanic, median age 37, IQR: 33-43), 181 were randomized to the intervention and 177 to control. Baseline mean (SD) weight was 98.6 kg (24.0) for intervention and 94.9 kg (20.3) for controls. 55 (30%) of intervention participants were adherent beyond one year. At 12 months, after controlling for CRT, sex, race/ethnicity, and age, the adjusted mean (SE) change in weight from baseline was -1.83kg (0.7) for intervention and -0.16kg (0.64) for control participants. At 24 months, the adjusted mean (SE) change in weight was -0.36kg (0.78) for intervention and +0.18kg (0.66) for control participants with the average difference of -0.54 kg (95%CI: -2.5,1.5, p=0.59) between the arms. A small proportion had at least 5% weight loss at 24 months (intervention 24%; control 17%). No significant differences in CV risk factors were observed. Conclusions: A 24-month phone and app/web-based diet and physical activity intervention that was successful for weight loss in the general population did not result in greater weight loss or improvement in CV risk factors among adult survivors of childhood ALL. Reduced adherence to the intervention beyond 12 months, or lack of ALL survivor-specific tailoring, may account for these findings. Clinical trial information: NCT02244411. [Table: see text]