Effect of a comprehensive lifestyle intervention program on body weight and health behavior in women with breast cancer: Results from a randomized controlled trial
Abstract
BACKGROUND
Both overweight/obesity and a Western lifestyle are associated with a poorer prognosis in women with breast cancer. The primary aim of this analysis was to examine the effect of a telephone-delivered lifestyle intervention program on reducing body weight and waist circumference, decreasing cardiovascular risk factors and improving lifestyle.
DESIGN
Data is derived from an open-label, randomized, controlled phase III study that evaluated two chemotherapy regimens and the impact of a 2-year lifestyle intervention on disease-free survival and secondary outcomes in women with intermediate-risk to high-risk breast cancer. Initially, 2292 women with a body mass index (BMI) between 24 and 40 kg/m2 were randomized into one of two arms of the lifestyle intervention study. After accounting for dropout, 1785 participants remained: 776 in the intervention group (IG) who received a telephone-delivered lifestyle intervention supported by mailed materials, and 1009 in the low-level intervention group (LLIG) who received only mailed educational materials with general recommendations for a healthy lifestyle. Body weight, waist circumference, dietary intake, physical activity, and cardiovascular disease risk parameters were measured repeatedly throughout the intervention and a subsequent 2-year follow-up period. Linear mixed models for repeated measures were used to assess differences in study outcomes between the LLIG and IG at each measured time point.
RESULTS
IG participants…
How strong is the evidence?
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. Reported size: 2,292 participants or records.
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