Xu Miao, Chattopadhyay Kaushik, Li Jialin, Rai Nanin, Chen Yanshu, Hu Fangfang, Chu Jianping, Li Li
Department of Endocrinology and Metabolism, Ningbo First Hospital, Ningbo, China.
Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
Front Public Health. 2019 Dec 18;7:388. doi: 10.3389/fpubh.2019.00388. eCollection 2019.
To investigate the feasibility of conducting a randomized controlled trial (RCT) of a weight management programme in Ningbo, China. A pre- and post-intervention study was conducted in Ningbo. The study duration was from 01 July 2015 to 30 September 2017. Those aged 18-65 years of age, with a body mass index (BMI) of ≥24 kg/m (i.e., overweight/obese) and were willing to comply with the weight management programme were included in the study. The programme, focusing on lifestyle modification, was delivered by a multidisciplinary team over a period of 3-months. The study parameters were recruitment rate, follow-up rates at 3- and 6-month and standard deviation (SD) of the outcome measure (i.e., BMI). Out of 261 people who gave written informed consent and were screened for eligibility, 193 (74%) were found eligible and were enrolled on to the programme. Those who enrolled on to the programme, 185 (96%) and 169 (88%) were followed up at 3- and 6-month, respectively. The SD of the outcome measure was 4.85. BMI reduced at 3-month follow-up (-1.98, 95% CI -2.19 to -1.79, < 0.001) and at 6-month follow-up (-2.42, -2.71 to -2.11, <0.001). Based on the promising recruitment and follow-up rates in this study, it would be feasible to undertake the RCT of the weight management programme for overweight and obese adults in Ningbo. The SD of the outcome measure is used to calculate the sample size of the RCT. www.ClinicalTrials.gov, identifier: ChiCTR1900025861.
为研究在中国宁波开展一项体重管理计划随机对照试验（RCT）的可行性。在宁波进行了一项干预前后研究。研究时间为2015年7月1日至2017年9月30日。纳入研究的对象为年龄在18 - 65岁、体重指数（BMI）≥24 kg/m²（即超重/肥胖）且愿意遵守体重管理计划的人群。该计划侧重于生活方式改变，由多学科团队在3个月的时间内实施。研究参数包括招募率、3个月和6个月时的随访率以及结果指标（即BMI）的标准差（SD）。在261名签署书面知情同意书并接受资格筛查的人中，193人（74%）被判定符合条件并纳入该计划。纳入该计划的人群中，分别有185人（96%）和169人（88%）在3个月和6个月时接受了随访。结果指标的标准差为4.85。在3个月随访时BMI降低（-1.98，95%可信区间-2.19至-1.79，<0.001），在6个月随访时BMI降低（-2.42，-2.71至-2.11，<0.001）。基于本研究中可观的招募率和随访率，对宁波超重和肥胖成年人开展体重管理计划的随机对照试验是可行的。结果指标的标准差用于计算随机对照试验的样本量。www.ClinicalTrials.gov，标识符：ChiCTR1900025861。
