Voils C I, Grubber J M, McVay M A, Olsen M K, Bolton J, Gierisch J M, Taylor S S, Maciejewski M L, Yancy W S
Center for Health Services Research in Primary Care Durham Veterans Affairs Medical Center Durham NC USA; Department of Medicine Duke University Medical Center Durham NC USA.
Center for Health Services Research in Primary Care Durham Veterans Affairs Medical Center Durham NC USA.
Obes Sci Pract. 2016 Dec;2(4):355-365. doi: 10.1002/osp4.58. Epub 2016 Aug 26.
A weight loss maintenance trial involving weight loss prior to randomization is challenging to implement due to the potential for dropout and insufficient weight loss. We examined rates and correlates of non-initiation, dropout, and insufficient weight loss during a weight loss maintenance trial.
The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg. Psychosocial measures were administered during a screening visit. Weight was obtained at the first group session and 16 weeks later to determine eligibility for randomization.
Of 573 patients who screened as eligible, 69 failed to initiate the weight loss program. In adjusted analyses, failure to initiate was associated with lower age, lack of a support person, and less encouragement for making dietary changes. Among participants who initiated, 200 dropped out, 82 lost insufficient weight, and 222 lost sufficient weight for randomization. Compared to losing sufficient weight, dropping out was associated with younger age and tobacco use, whereas losing insufficient weight was associated with non-White race and controlled motivation for physical activity.
Studies should be conducted to evaluate strategies to maximize recruitment and retention of subgroups that are less likely to initiate and be retained in weight loss maintenance trials.
由于存在失访风险和体重减轻不足的可能性,一项涉及随机分组前进行体重减轻的体重维持试验实施起来具有挑战性。我们研究了体重维持试验期间未开始、失访和体重减轻不足的发生率及相关因素。
MAINTAIN试验包括一个为期16周的体重减轻计划,随后对体重减轻至少4千克的参与者进行随机分组。在筛查访视期间进行社会心理测量。在第一次小组会议时及16周后测量体重,以确定随机分组的资格。
在573名筛查合格的患者中,69人未开始体重减轻计划。在调整分析中,未开始与年龄较小、缺乏支持人员以及饮食改变的鼓励较少有关。在开始计划的参与者中,200人退出,82人体重减轻不足,222人体重减轻足够可进行随机分组。与体重减轻足够相比,退出与年龄较小和吸烟有关,而体重减轻不足与非白人种族和有控制的身体活动动机有关。
应开展研究以评估策略,从而最大限度地招募和留住那些在体重维持试验中不太可能开始并坚持下去的亚组人群。