Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial.

Being overweight or obese (OW/OB) during B-cell acute lymphoblastic leukemia (B-ALL) induction is associated with chemoresistance as quantified by minimal residual disease (MRD). We hypothesized that caloric and nutrient restriction from diet/exercise could lessen gains in fat mass (FM) and reduce postinduction MRD. The Improving Diet and Exercise in ALL (IDEAL) trial enrolled patients 10 to 21 years old, newly diagnosed with B-ALL (n = 40), in comparison with a recent historical control (n = 80). Designed to achieve caloric deficits ≥20% during induction, reduce fat intake/glycemic load, and increase activity, IDEAL's end points were FM gain (primary), MRD ≥0.01%, and adherence/feasibility. Integrated biology explored biomarkers of OW/OB physiology. IDEAL intervention did not significantly reduce median FM change from baseline overall (+5.1% [interquartile range [IQR], 15.8] vs +10.7% [IQR, 16.0]; P = .13), but stratified analysis showed benefit in those OW/OB (+1.5% [IQR, 6.6] vs +9.7% [IQR, 11.1]; P = .02). After accounting for prognostic factors, IDEAL intervention significantly reduced MRD risk (odds ratio, 0.30; 95% confidence interval, 0.09-0.92; P = .02). The trial exceeded its adherence (≥75% of overall diet) and feasibility (≥80% completed visits) thresholds. Integrated biology found the IDEAL intervention increased circulating adiponectin and reduced insulin resistance. The IDEAL intervention was feasible, decreased fat gain in those OW/OB, and reduced MRD. This is the first study in any hematologic malignancy to demonstrate potential benefit from caloric restriction via diet/exercise to augment chemotherapy efficacy and improve disease response. A prospective, randomized trial is warranted for validation. These trials were registered at www.clinicaltrials.gov as #NCT02708108 (IDEAL trial) and #NCT01317940 (historical control).

Development and validation of the mindful eating questionnaire.

"Mindful eating" describes a nonjudgmental awareness of physical and emotional sensations associated with eating. This article reports the development of a mindful eating questionnaire (MEQ) to support rigorous scientific inquiry into this concept. An item pool was developed based on hypothesized domains of mindful eating. A cross-sectional survey examined associations of MEQ scores with demographic and health-related characteristics. The MEQ was distributed to seven convenience samples between January and May 2007, with an overall response rate of 62% (n=303). Participants were mostly women (81%) and white (90%), and had a mean age of 42+/-14.4 years (range 18 to 80 years). Exploratory factor analysis was used to identify factors, which were defined as the mean of items scored one to four, where four indicated higher mindfulness; the mean of all factors was the summary MEQ score. Multiple regression analysis was used to measure associations of demographic characteristics, obesity, yoga practice, and physical activity with MEQ scores. Domains of the final 28-item questionnaire were: disinhibition, awareness, external cues, emotional response, and distraction. The mean MEQ score was 2.92+/-0.37, with a reliability (Chronbach's alpha) of .64. The covariate-adjusted MEQ score was inversely associated with body mass index (3.02 for body mass index <25 vs 2.54 for body mass index >30, P<0.001). Yoga practice, but neither walking nor moderate/intense physical activity, was associated with higher MEQ score. In this study sample, the MEQ had good measurement characteristics. Its negative association with body mass index and positive association with yoga provide evidence of construct validity. Further evaluation in more diverse populations is warranted.