A randomized trial of a multimodal lifestyle intervention in cancer survivors
Abstract
Introduction Cancer survivors are often insufficiently physically active, have overweight or obesity, and suboptimal cardiorespiratory fitness. The Small Steps study evaluated a multimodal intervention to address these modifiable risk factors. Methods The study randomized 33 cancer survivors to a 10-week multimodal lifestyle intervention (MLI) of exercise training and nutritional counseling or waitlist control (WLC). The co-primary endpoints included body weight and cardiorespiratory fitness capacity; secondary and exploratory endpoints included cardiometabolic and patient-reported measures. Endpoints were analyzed using analysis of covariance. Results Participants had a mean (SD) age of 60.3 (14.0) years, 26 (79%) were White, and 18 (55%) were survivors of breast cancer. At baseline, the mean body weight was 94.9 (18.3) kg, and the submaximal cardiopulmonary fitness was 16.4 (5.0) mL/kg/min. As compared with WLC, MLI reduced body weight [−2.3 kg (95% CI: −3.6, −0.9); P = 0.0013; −2.8% (95% CI: −4.3, −1.3)] and increased cardiopulmonary fitness [2.0 mL/kg/min (95% CI: 0.3, 3.8); P = 0.022]. MLI reduced waist circumference [−2.9 cm (95% CI: −5.5, −0.3); P = 0.029], fat mass [−1.7 kg (95% CI: −2.9, −0.5); P = 0.005], visceral adipose tissue [−168.0 cm3 (95% CI: −380.4, −27.7); P = 0.019], and improved self-reported vitality [12.2 points (95% CI: 1.6, 22.8); P = 0.024] and social functioning [14.2 points (95% CI: 1.1, 27.4); P = 0.034]. MLI did not reduce lean mass [−0.2 kg…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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