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癌症幸存者及其伴侣的基于网络的双联随机对照减肥干预试验的原理和方法:DUET 研究。

Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study.

机构信息

Department of Health Behavior, University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.

O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), Birmingham, AL 35294, USA.

出版信息

Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.

DOI:10.3390/nu13103472
PMID:34684474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8539255/
Abstract

Scalable, effective interventions are needed to address poor diet, insufficient physical activity, and obesity amongst rising numbers of cancer survivors. Interventions targeting survivors and their friends and family may promote both tertiary and primary prevention. The design, rationale, and enrollment of an ongoing randomized controlled trial (RCT) (NCT04132219) to test a web-based lifestyle intervention for cancer survivors and their supportive partners are described, along with the characteristics of the sample recruited. This two-arm, single-blinded RCT randomly assigns 56 dyads (cancer survivor and partner, both with obesity, poor diets, and physical inactivity) to the six-month DUET intervention vs. wait-list control. Intervention delivery and assessment are remotely performed with 0-6 month, between-arm tests comparing body weight status (primary outcome), and secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation). Despite COVID-19, targeted accrual was achieved within 9 months. Not having Internet access was a rare exclusion (<2%). Inability to identify a support partner precluded enrollment of 42% of interested/eligible survivors. The enrolled sample is diverse: ages 23-81 and 38% racial/ethnic minorities. Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.

摘要

需要可扩展且有效的干预措施来解决越来越多癌症幸存者中不良饮食、身体活动不足和肥胖的问题。针对幸存者及其朋友和家人的干预措施可能同时促进三级和一级预防。本文介绍了一项正在进行的随机对照试验(RCT)(NCT04132219)的设计、原理和入组情况,该试验旨在测试一种针对癌症幸存者及其支持性伴侣的基于网络的生活方式干预措施,同时还介绍了招募的样本特征。这是一项两臂、单盲 RCT,将 56 对(癌症幸存者和伴侣,均肥胖、饮食不良且身体活动不足)随机分配到为期 6 个月的 DUET 干预组和等候名单对照组。通过远程进行干预和评估,在 0-6 个月时进行组间比较,比较身体体重状况(主要结局)以及次要结局(腰围、健康指标和葡萄糖稳态、脂质调节和炎症的生物标志物)。尽管受到 COVID-19 的影响,但在 9 个月内实现了目标入组。没有互联网接入是罕见的排除因素(<2%)。无法确定支持伙伴导致 42%有兴趣/符合条件的幸存者无法入组。入组样本多样化:年龄 23-81 岁,38%为少数族裔。研究结果支持针对癌症幸存者的基于网络的生活方式干预措施的可及性和吸引力,但一些癌症幸存者难以招募支持伙伴,可能需要替代策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/109e/8539255/7d2c69f1de7c/nutrients-13-03472-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/109e/8539255/7d2c69f1de7c/nutrients-13-03472-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/109e/8539255/7d2c69f1de7c/nutrients-13-03472-g001.jpg

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