JAMA:对肥胖男性进行经济激励的短信:一项随机临床试验

2024-05-17 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

原文链接:https://doi.org/10.1001/jama.2024.7064

摘要内容如下:

重要性

肥胖男性需要有效的减肥干预。

目的

确定在12个月的随访中,与对照组相比,将短信与经济激励相结合的干预是否获得了显著的体重减轻,以及在12个月的随访中,与对照组相比,单独的短信干预是否获得了显著的体重减轻。

设计、设置和参与者

在英国贝尔法斯特、布里斯托尔和格拉斯哥地区进行的一项评估者盲法随机临床试验。在2021年7月至2022年5月期间,共有585名身体质量指数(BMI)为30或以上的男性入组。最后一次随访发生在2023年6月。

干预措施

参与者被随机分配到12个月的以行为为重点的短信与经济激励相结合(n=196),12个月的单独以行为为重点的短信(n=194),或等待名单(对照组;n=195)。经济激励包括金钱奖励,如果没有达到减肥目标,就会失去金钱奖励。所有参与者在基线时都接受了体重管理信息和计步器。

主要成果和措施

两个主要比较是12个月参与者体重变化的比较,一是有经济激励的短信组和对照组之间的比较,二是单独短信组和对照组之间的比较(最小临床重要差异,3%)。每个比较的统计学显著性定义的P值为P<.025。

结果

585名男性(平均[SD]年龄,50.7[13.3]岁;平均体重118.5[19.9]公斤;平均BMI,37.7[5.7];525名[90%]白人),227名(39%)居住在社会经济地位较低的邮政编码地区,426名(73%)完成了12个月的随访。在12个月的随访中,与对照组相比,发短信和金钱激励组的平均体重百分比变化显著更大(平均差异,-3.2%;97.5%可信区间,-4.6%~-1.9%;P<.001),但在单独的短信组中没有显著增加(平均差异,-1.4%;97.5%CI,-2.9%至0.0,P=.05)。有财务激励的短信组的平均(SD)体重变化为-5.7(7.4)kg,单独短信组为-3.0(7.5)kg,对照组为-1.5(6.6)kg。与基线相比,12个月的平均(SD)体重变化百分比为:有财务激励的短信组为-4.8%(6.1%),单独短信组为-2.7%(6.3%),对照组为-1.3%(5.5%)。在报告的366例不良事件中,最常见的是感染(83[23%])。在23例严重不良事件(6.3%)中,12例(52%)发生在有经济激励的短信组,5例(22%)发生在单纯短信组,6例(26%)发生在对照组。没有人被认为与参加试验组有关。

结论和相关性

在患有肥胖症的男性中,与对照组相比,有金钱激励的短信干预显著改善了体重减轻,而单独发短信并没有显著优于对照组。这些发现支持短信与经济激励相结合,以实现肥胖男性的减肥。

试用注册

.org标识符:ISRCTN91974895。

英文原文如下:

Abstracts

Importance  Effective weight loss interventions are needed for men with obesity.

Objective  To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group.

Design, Setting, and Participants  An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023.

Interventions  Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline.

Main Outcomes and Measures  The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison.

Results  Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group.

Conclusion and Relevance  Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity.

Trial Registration  isrctn.org Identifier: ISRCTN91974895.

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