12-Month Outcomes and Process Evaluation of the SHED-IT RCT: An Internet-Based Weight Loss Program Targeting Men

12-Month Outcomes and Process Evaluation of the SHED-IT RCT: An Internet-Based Weight Loss Program Targeting Men
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DOI:
10.1038/oby.2010.119
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发表时间:
2011-01-01
期刊:
影响因子:
6.9
通讯作者:
Callister, Robin
Callister, Robin
中科院分区:
医学2区
文献类型:
--
作者:
Morgan, Philip J.;Lubans, David R.;Callister, Robin

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本文报道了SHED-IT(自助,运动和饮食使用信息技术)试验的12个月随访结果和过程评估,这是一个专门针对男性的基于互联网的减肥计划。65名超重/肥胖的男性工作人员和学生在纽卡斯尔大学(卡拉汉,澳大利亚)(平均值(s.d.)年龄= 35.9(11.1)岁; BMI = 30.6(2.8))被随机分配到(i)互联网组(n = 34)或(ii)仅信息对照组(n = 31)。两人都收到了一次面对面的信息会议和一本节目手册。互联网组的参与者被指示使用研究网站3个月。参与者在基线、3个月、6个月和12个月随访时评估体重、腰围、BMI、血压和静息心率。3个月和12个月的保留率分别为85%和71%。使用线性混合模型进行的意向治疗(ITT)分析显示,12个月时互联网组体重显著持续减轻,为-5.3 kg(95%置信区间(CI):-7.5,-3.0),对照组为-3.1 kg(95% CI:-5.4,-0.7),无组间差异。所有结果均存在显著的时间效应(P < 0.001)。符合方案分析显示,体重、腰围、BMI和收缩压存在显著的组-时间相互作用。互联网组依从者(按照指导进行自我监测)在12个月时保持了比不依从者(-1.9 kg; 95% CI-4.8,1.0)和对照组(-3.0 kg; 95% CI-5.2,-0.9)更大的体重减轻(-8.8 kg; 95% CI-11.8,-5.9)。通过问卷调查和访谈的定性分析强调了SHED-IT的可接受性和满意度。低剂量减肥方法是可行的,可接受的,并且在随访1年后可以在男性中实现临床上重要的体重减轻。
This article reports the 12-month follow-up results and process evaluation of the SHED-IT (Self-Help, Exercise, and Diet using Information Technology) trial, an Internet-based weight loss program exclusively for men. Sixty-five overweight/obese male staff and students at the University of Newcastle (Callaghan, Australia) (mean (s.d.) age = 35.9 (11.1) years; BMI = 30.6 (2.8)) were randomly assigned to either (i) Internet group (n = 34) or (ii) Information only control group (n = 31). Both received one face-to-face information session and a program booklet. Internet group participants were instructed to use the study website for 3 months. Participants were assessed at baseline, 3-, 6-, and 12-month follow-up for weight, waist circumference, BMI, blood pressure, and resting heart rate. Retention at 3-and 12-months was 85% and 71%, respectively. Intention-to-treat (ITT) analysis using linear mixed models revealed significant and sustained weight loss of -5.3 kg (95% confidence interval (CI): -7.5, -3.0) at 12 months for the Internet group and -3.1 kg (95% CI: -5.4, -0.7) for the control group with no group difference. A significant time effect was found for all outcomes (P < 0.001). Per-protocol analysis revealed a significant group-by-time interaction for weight, waist circumference, BMI, and systolic blood pressure. Internet group compliers (who self-monitored as instructed) maintained greater weight loss at 12 months (-8.8 kg; 95% CI -11.8, -5.9) than noncompliers (-1.9 kg; 95% CI -4.8, 1.0) and controls (-3.0 kg; 95% CI -5.2, -0.9). Qualitative analysis by questionnaire and interview highlighted the acceptability and satisfaction with SHED-IT. Low-dose approaches to weight loss are feasible, acceptable, and can achieve clinically important weight loss in men after 1-year follow-up.