Impact of a Weight Loss Intervention on 1-Year Weight Change in Women With Stage II/III Breast Cancer: Secondary Analysis of the Breast Cancer Weight Loss (BWEL) Trial.

Scalable interventions are needed to promote weight loss in this population.

需要可扩展的干预措施来促进这一人群的减重。

Background

To evaluate the impact of a remotely delivered weight loss intervention (WLI) on weight change at 1 year in patients with breast cancer and obesity and to explore factors associated with weight change.

评估远程体重减轻干预（WLI）对乳腺癌和肥胖患者一年内体重变化的影响，并探讨与体重变化相关的因素。

DESIGN, SETTING, AND PARTICIPANTS: The Breast Cancer Weight Loss trial is a phase 3, randomized clinical trial evaluating the impact of a telephone-based WLI on invasive disease-free survival and other outcomes in women with obesity and early breast cancer at 637 sites across the US and Canada.

设计、环境和参与者：乳腺癌减重试验是一项第三阶段的随机临床试验，评估电话远程体重减轻干预（WLI）对肥胖和早期乳腺癌女性侵袭性疾病无病生存期和其他结果的影响，在美国和加拿大的637个地点进行。

Participants were enrolled to the study between August 2016 and February 2021.

参与者在2016年8月至2021年2月期间被纳入研究。

Participants included women with stage II to III, ERBB2-negative breast cancer and a body mass index (BMI) of 27 or higher.

参与者包括患有II至III期、ERBB2阴性乳腺癌且体重指数（BMI）为27或更高的女性。

Methods

Participants were randomized to a 2-year, telephone-based WLI plus health education or health education alone control group.

参与者被随机分配到一个为期2年的电话基础体重减轻干预（WLI）加健康教育或仅健康教育对照组。

main_outcome_and_measures

The primary end point for this prespecified secondary analysis was weight change at 1 year.

这项预先指定的次要分析的主要终点是1年时的体重变化。

Weight was measured at baseline and 1 year, and changes in weight were compared between groups.

在基线和1年时测量体重，并比较了各组之间的体重变化。

Weight change was evaluated with a linear mixed-effects model including treatment group, weight over time, a time-by-group interaction, menopausal status, race and ethnicity, and hormone receptor status.

通过线性混合效应模型评估体重变化，该模型包括治疗组、随时间变化的体重、时间与组别的交互作用、绝经状态、种族和民族以及激素受体状态。

Results

A total of 3180 women with breast cancer and BMI of 27 and higher were included in the study; 1591 were randomized to the WLI and 1589 to the control group.

本研究共纳入了3180名BMI为27及以上的乳腺癌女性患者；其中1591名被随机分配至体重减轻干预组（WLI），1589名被分配至对照组。

At baseline, the mean (SD) age of participants was 53.4 (10.6), and the mean (SD) BMI was 34.4 (5.6).

在基线时，参与者的平均（标准差）年龄为53.4（10.6）岁，平均（标准差）BMI为34.4（5.6）。

The racial and ethnic breakdown included 406 (12.8%) Black, 231 (7.3%) Hispanic or Latino, 2906 (91.4%) non-Hispanic, and 2555 (80.3%) White participants.

种族和民族构成包括406名（12.8%）黑人，231名（7.3%）西班牙裔或拉丁裔，2906名（91.4%）非西班牙裔，以及2555名（80.3%）白人参与者。

WLI participants lost a mean of 4.3 kg (95% CI 3.9-4.6 kg), or 4.7% (95% CI, 4.3%-5.0%) of baseline body weight at 1 year vs control participants, who gained 0.9 kg (95% CI, 0.5-1.3 kg), or 1.0% (95% CI 0.1%-1.4%) of baseline body weight (P < .001).

WLI参与者在1年内平均减轻了4.3公斤（95%置信区间3.9-4.6公斤），占基线体重的4.7%（95%置信区间，4.3%-5.0%），而对照组参与者增加了0.9公斤（95%置信区间，0.5-1.3公斤），占基线体重的1.0%（95%置信区间0.1%-1.4%）（P < .001）。

Participants randomized to WLI experienced significant weight loss (vs control group participants) across demographic and tumor factors.

随机分配到体重减轻干预（WLI）的参与者在人口统计学和肿瘤因素方面经历了显著的体重减轻（与对照组参与者相比）

WLI effect differed significantly by menopausal status, with postmenopausal participants having greater weight loss than premenopausal participants, and by race and ethnicity, with Black and Hispanic participants having less weight loss compared to other races and ethnicities.

WLI的效果因绝经状态而显著不同，绝经后参与者的体重减轻大于绝经前参与者，种族和民族也存在显著差异，黑人和西班牙裔参与者的体重减轻比其他种族和民族的参与者少。

conclusions_and_relevance

In this secondary analysis of a randomized clinical trial, a telephone-based WLI induced significant weight loss in patients with breast cancer with overweight and obesity across demographic and treatment factors.

在这项随机临床试验的二次分析中，基于电话的体重减轻干预（WLI）在具有超重和肥胖的乳腺癌患者中诱导了显著的体重减轻，这一效果跨越了人口统计学和治疗因素的差异。

Further follow-up of the Breast Cancer Weight Loss trial will evaluate whether the WLI improves disease outcomes.

乳腺癌体重减轻试验的进一步随访将评估WLI是否改善疾病结果。

trial_registration

ClinicalTrials.gov Identifier: NCT02750826.

临床试验注册号：NCT02750826。