Nutrition and Dietetics, School of Health Sciences, Faculty of Health, The University of Newcastle, Callaghan, NSW, 2308 Australia.
BMC Public Health. 2010 Nov 3;10:669. doi: 10.1186/1471-2458-10-669.
Obesity rates in adults continue to rise and effective treatment programs with a broad reach are urgently required. This paper describes the study protocol for a web-based randomized controlled trial (RCT) of a commercially available program for overweight and obese adult males and females. The aim of this RCT was to determine and compare the efficacy of two web-based interventions for weight loss and maintenance of lost weight.
METHODS/DESIGN: Overweight and obese adult males and females were stratified by gender and BMI and randomly assigned to one of three groups for 12-weeks: waitlist control, or basic or enhanced online weight-loss. Control participants were re-randomized to the two weight loss groups at the end of the 12-week period. The basic and enhanced group participants had an option to continue or repeat the 12-week program. If the weight loss goal was achieved at the end of 12, otherwise on completion of 24 weeks of weight loss, participants were re-randomized to one of two online maintenance programs (maintenance basic or maintenance enhanced), until 18 months from commencing the weight loss program. Assessments took place at baseline, three, six, and 18 months after commencing the initial weight loss intervention with control participants repeating the initial assessment after three month of waiting. The primary outcome is body mass index (BMI). Other outcomes include weight, waist circumference, blood pressure, plasma markers of cardiovascular disease risk, dietary intake, eating behaviours, physical activity and quality of life.Both the weight loss and maintenance of lost weight programs were based on social cognitive theory with participants advised to set goals, self-monitor weight, dietary intake and physical activity levels. The enhanced weight loss and maintenance programs provided additional personalized, system-generated feedback on progress and use of the program. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention programs, assessments and statistical analyses are described.
Importantly, this paper describes how an RCT of a currently available commercial online program in Australia addresses some of the short falls in the current literature pertaining to the efficacy of web-based weight loss programs.Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12610000197033.
成年人的肥胖率持续上升,迫切需要能够广泛覆盖的有效治疗方案。本文介绍了一项基于网络的随机对照试验(RCT)的研究方案,该试验针对超重和肥胖的成年男性和女性,评估一种商业化的在线项目的效果。本 RCT 的目的是确定和比较两种基于网络的干预措施在减肥和维持减肥效果方面的疗效。
方法/设计:根据性别和 BMI 将超重和肥胖的成年男性和女性分层,然后将他们随机分为三组,进行为期 12 周的干预:等待对照组、基础在线减肥组或强化在线减肥组。对照组参与者在 12 周结束时重新随机分配到两个减肥组。基础组和强化组的参与者可以选择继续或重复进行 12 周的方案。如果在 12 周结束时达到减肥目标,则进入下一步;如果未达到,则在完成 24 周的减肥后,参与者将重新随机分配到两个在线维持方案之一(维持基础或维持强化),直到从开始减肥方案起 18 个月。在开始初始减肥干预后的基线、3 个月、6 个月和 18 个月进行评估,等待 3 个月的对照组参与者重复初始评估。主要结局指标是体重指数(BMI)。其他结局指标包括体重、腰围、血压、心血管疾病风险的血浆标志物、膳食摄入量、饮食行为、身体活动和生活质量。减肥和维持减肥方案均基于社会认知理论,建议参与者设定目标、自我监测体重、膳食摄入量和身体活动水平。强化减肥和维持方案提供了额外的个性化、系统生成的进度反馈和方案使用反馈。本文详细介绍了招募、纳入标准、随机化、干预方案、评估和统计分析等方面的方法学细节。
本文重要地描述了澳大利亚一项目前可用的商业化在线项目的 RCT 如何解决当前关于基于网络的减肥方案疗效的文献中的一些不足之处。
澳大利亚新西兰临床试验注册中心(ANZCTR)编号:ACTRN12610000197033。