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2型糖尿病PULSE项目随机对照试验的过程评估:招募、参与度和总体满意度

Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

作者信息

Aguiar Elroy J, Morgan Philip J, Collins Clare E, Plotnikoff Ronald C, Young Myles D, Callister Robin

机构信息

1 Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW, Australia.

2 School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.

出版信息

Am J Mens Health. 2017 Jul;11(4):1055-1068. doi: 10.1177/1557988317701783. Epub 2017 Apr 19.

DOI:10.1177/1557988317701783
PMID:28423969
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5675346/
Abstract

BACKGROUND

Men are underrepresented in weight loss and type 2 diabetes mellitus (T2DM) prevention studies.

PURPOSE

To determine the effectiveness of recruitment, and acceptability of the T2DM Prevention Using LifeStyle Education (PULSE) Program-a gender-targeted, self-administered intervention for men.

METHODS

Men (18-65 years, high risk for T2DM) were randomized to intervention ( n = 53) or wait-list control groups ( n = 48). The 6-month PULSE Program intervention focused on weight loss, diet, and exercise for T2DM prevention. A process evaluation questionnaire was administered at 6 months to examine recruitment and selection processes, and acceptability of the intervention's delivery and content. Associations between self-monitoring and selected outcomes were assessed using Spearman's rank correlation.

RESULTS

A pragmatic recruitment and online screening process was effective in identifying men at high risk of T2DM (prediabetes prevalence 70%). Men reported the trial was appealing because it targeted weight loss, T2DM prevention, and getting fit, and because it was perceived as "doable" and tailored for men. The intervention was considered acceptable, with men reporting high overall satisfaction (83%) and engagement with the various components. Adherence to self-monitoring was poor, with only 13% meeting requisite criteria. However, significant associations were observed between weekly self-monitoring of weight and change in weight ( r = -.47, p = .004) and waist circumference ( r = -.38, p = .026). Men reported they would have preferred more intervention contact, for example, by phone or email.

CONCLUSIONS

Gender-targeted, self-administered lifestyle interventions are feasible, appealing, and satisfying for men. Future studies should explore the effects of additional non-face-to-face contact on motivation, accountability, self-monitoring adherence, and program efficacy.

摘要

背景

在减肥和2型糖尿病(T2DM)预防研究中,男性参与者人数不足。

目的

确定招募的有效性,以及使用生活方式教育预防2型糖尿病(PULSE)计划(一种针对男性的自我管理干预措施)的可接受性。

方法

将男性(18 - 65岁,T2DM高危人群)随机分为干预组(n = 53)或等待名单对照组(n = 48)。为期6个月的PULSE计划干预重点是通过减肥、饮食和运动来预防T2DM。在6个月时进行了一项过程评估问卷调查,以检查招募和筛选过程,以及干预措施的实施和内容的可接受性。使用Spearman等级相关性评估自我监测与选定结果之间的关联。

结果

一个实用的招募和在线筛查过程有效地识别出了T2DM高危男性(糖尿病前期患病率70%)。男性报告称该试验很有吸引力,因为它以减肥、预防T2DM和健身为目标,并且被认为“可行”且是为男性量身定制的。该干预措施被认为是可接受的,男性报告总体满意度较高(83%),并且参与了各个组成部分。自我监测的依从性较差,只有13%的人符合必要标准。然而,观察到每周体重自我监测与体重变化(r = -0.47,p = 0.004)和腰围变化(r = -0.38,p = 0.026)之间存在显著关联。男性报告他们更希望有更多的干预接触,例如通过电话或电子邮件。

结论

针对男性的自我管理生活方式干预措施是可行的、有吸引力的且令人满意的。未来的研究应探讨额外的非面对面接触对动机、责任感、自我监测依从性和项目效果的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a73/5675346/051864b82316/10.1177_1557988317701783-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a73/5675346/051864b82316/10.1177_1557988317701783-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a73/5675346/051864b82316/10.1177_1557988317701783-fig1.jpg

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