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临床试验/NCT05556577
NCT05556577撤回不适用

Weight Cycle Impacted by Health Lifestyle Post Pharmacotherapy Intervention

Shanghai Zhongshan Hospital0 个研究点开始时间: 2022年9月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
the change in body weight

研究概览

简要总结

The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.

详细描述

This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study.

Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

排除标准

  • Those in the SURMOUNT-CN trial who denied to participant.

结局指标

主要结局

the change in body weight

时间窗: at week 65 and week 78 from study baseline

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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