Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team
Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team
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DOI：
10.1002/osp4.57
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发表时间：
2016-09-01
影响因子：
2.2
通讯作者：
Digenio, A.
中科院分区：
文献类型：
--
作者：
Delahanty, L. M.;Riggs, M.;Digenio, A.
在减肥药的长期临床试验中观察到高损耗率。我们评估了一个创新的保留项目对1年retention.MethodsThree的3期全球多中心临床试验的影响评估了CB 1受体拮抗剂的有效性和安全性与BMI ≥ 27 kg/m（2）的受试者。在来自四个亚群的4,410名受试者中评估了多方面保留计划的影响，包括营养师筛选访谈，全面的文化适应生活方式改变计划，以及营养师支持系统，以最大限度地坚持生活方式（非美国英语国家，非英语国家，美国-没有营养师筛选和美国-营养师筛选），包括208个中心，从15个countries.ResultsThe中位比例保留在第一年的三个协议之间的主题是82%。非英语国家的保留率（89%）高于美国（73%）和非美国英语国家（81%）。在美国，行为筛查与辍学率下降29%;每五个月的电话会议出席以上11，有一个32%的下降dropout rate.ConclusionsThis新的保留方案大大提高后，报告的保留率与其他减肥药进行长期临床试验的研究。其有效性应在今后的试验中得到证实。
ObjectiveHigh-attrition rates have been observed in long-term clinical trials of weight loss agents. We evaluated the impact of an innovative retention programme on 1-year retention.MethodsThree Phase 3 global multicentre clinical trials evaluated the efficacy and safety of a CB1 receptor antagonist in subjects with BMI >= or = 27 kg/m(2). he impact of a multifaceted retention programme including a dietitian screening interview, a comprehensive culturally adapted lifestyle modification programme, and a dietitian support system to maximize lifestyle adherence, was evaluated in 4,410 subjects from four subpopulations (non-US English-speaking, non-English-speaking, US-without dietitian screening and US-with dietitian screening) comprising 208 centres from 15 countries.ResultsThe median proportion retained over the first year among subjects in three protocols was 82%. Non-English-speaking countries showed higher retention rates (89%) compared with the USA (73%) and non-US English-speaking (81%) countries. Within the USA, behavioural screening was associated with 29% reduction in dropout rate; for every five monthly teleconferences attended above 11, there was a 32% decrease in dropout rate.ConclusionsThis novel retention programme greatly improved upon reported retention rates of studies conducted with other weight loss agents in long-term clinical trials. Its effectiveness should be confirmed in future trials.