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HOMBRE:一项随机对照试验,比较两种针对超重和肥胖拉丁裔男性的减肥方法(Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas;有改善健康和降低慢性病风险选择的男性)。

HOMBRE: A randomized controlled trial to compare two approaches to weight loss for overweight and obese Latino men (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; men with choices to improve well-being and decrease chronic disease risk).

作者信息

Rosas Lisa G, Lv Nan, Azar Kristen M J, Xiao Lan, Hooker Steven P, Lewis Megan A, Zavella Patricia, Venditti Elizabeth M, Ma Jun

机构信息

Stanford University, 1070 Arastradero Rd. Suite 200, Palo Alto, CA 94304, United States.

Stanford University, 1070 Arastradero Rd. Suite 200, Palo Alto, CA 94304, United States.

出版信息

Contemp Clin Trials. 2018 May;68:23-34. doi: 10.1016/j.cct.2018.02.019. Epub 2018 Mar 2.

Abstract

Latino men bear a disproportionate burden of obesity, diabetes, and cardiovascular disease.However, limited behavioral lifestyle intervention research has focused on Latino men. This trial compares two approaches to weight loss for overweight and obese Latino men: 1) HOMBRE is a culturally adapted intervention that provides individual choice of either self-directed online videos, coach-facilitated in-person groups, and coach-facilitated online groups; and 2) a minimal intensity intervention that uses online videos with a coach available, if solicited by the participant.Latino men with a Body Mass Index (BMI) of ≥27 kg/m and one or more cardiometabolic risk factors (n = 424) will be randomly assigned to receive one of the two approaches.The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guides the planned evaluations.The primary aim is to determine the effectiveness of the HOMBRE intervention (the "E" in RE-AIM) on clinically significant weight loss (≥5% of baseline weight) at 18 months. We hypothesize that a significantly higher proportion of HOMBRE participants will maintain ≥5% of weight loss compared with those in the minimal intensity intervention.Secondary aims are to determine the effectiveness of HOMBRE on cardiometabolic risk factors (e.g., blood pressure, waist circumference), health behaviors (e.g., diet and physical activity), and psychosocial well-being (e.g., quality of life and depressive symptoms) and to evaluate the other attributes of RE-AIM. These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for Latino men in primary care.

摘要

拉丁裔男性承受着与肥胖、糖尿病和心血管疾病不相称的负担。然而,针对拉丁裔男性的行为生活方式干预研究有限。本试验比较了两种针对超重和肥胖拉丁裔男性的减肥方法:1)HOMBRE是一种经过文化调适的干预措施,提供三种选择:自主在线视频、教练指导的线下小组以及教练指导的在线小组;2)一种最低强度的干预措施,即使用在线视频,参与者如有需求可获得教练指导。体重指数(BMI)≥27 kg/m²且有一个或多个心脏代谢风险因素的拉丁裔男性(n = 424)将被随机分配接受这两种方法中的一种。RE-AIM(覆盖、效果、采纳、实施和维持)框架指导计划中的评估。主要目的是确定HOMBRE干预措施(RE-AIM中的“E”)在18个月时对临床上显著的体重减轻(≥基线体重的5%)的有效性。我们假设,与最低强度干预组相比,HOMBRE参与者中体重减轻≥5%的比例显著更高。次要目的是确定HOMBRE对心脏代谢风险因素(如血压、腰围)、健康行为(如饮食和体育活动)以及心理社会幸福感(如生活质量和抑郁症状)的有效性,并评估RE-AIM的其他属性。这些研究结果具有实际应用价值,对临床医生、患者以及其他考虑在初级保健中为拉丁裔男性制定有效糖尿病预防计划的决策者具有参考意义。

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